The National Alliance of Advocates
for Buprenorphine Treatment

Buprenorphine (Suboxone®, Subutex®3, Zubsolv™4, Probuphine®5) is an opioid medication used to treat opioid addiction in the privacy of a physician's office.1 Buprenorphine can be dispensed for take-home use, by prescription.1 This, in addition to the pharmacological and safety profile of buprenorphine, makes it an attractive treatment for patients addicted to opioids.2

FDA protects us from lifesaving drug

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FDA says no to safer, longer lasting, form of buprenorphine that cannot be lost, stolen, sold or accidentally ingested by children.


Background: Buprenorphine is the active ingredient in Suboxone and Subutex and their generic equivalents and considered to be the most significant new development in the treatment of opioid addiction in the last 50 years and the current standard of care. Buprenorphine essentially suppresses cravings and withdrawal symptoms enabling the patients to make long-term behavioral changes and rebuild their lives and ultimately achieve sustained addiction remission. –- more about the purpose of buprenorphine treatment

Imagine a form of buprenorphine which could not be lost stolen or sold, delivered a consistent daily dose (could not be overdosed or underdosed), ensured at least 6 months of medication compliance, had absolutely no risk of accidental pediatric exposure, and would still be effective at treating opioid addiction. Sounds like a miracle, or at least a major step forward, right? Not according to the FDA who earlier this year rejected such an advancement in treatment and for reasons largely unrelated to the medication’s lifesaving potential. Meanwhile, the CDC reports 45 people a day die from prescription opioid overdose.


In April, 2013 the FDA rejected Probuphine®, a new mode of administration of buprenorphine in the treatment of opioid addiction. Probuphine is a buprenorphine impregnated rod that is inserted just below the skin and provides a steady dose of buprenorphine for 6 months. On September 4th, Titan Pharmaceuticals, the manufacturer, requested a meeting to review the decision with the FDA to urge them to reverse their decision. This medication would fill the needs of an underserved population who desperately need it; and we believe the FDA should reconsider. UPDATE: The FDA has agreed to a November 19th meeting. Update: Meeting Results

The FDA’s decision to reject Probuphine was a surprise. Not only because it was inconsistent with the recommendation of their own appointed advisory committee which voted to approve it, but also because it was in contrast to epidemic warnings from the CDC; the stated policy of the ONDCP; diversion concerns of the DEA; industry safety trends; and statements from the FDA itself.

  • The CDC characterized the prescription opioid overdose problems as an epidemic killing 45 people a day (that’s more suicides, US combat deaths, and even Chicago killings). More stunning is that 45 people a day figure does NOT include heroin overdoses – it's prescription opioid medications only.

  • The ONDCP is committed to expanding evidence-based treatments, prevent diversion and reduce accidental overdose deaths.

  • The DEA is so concerned about diversion of buprenorphine film and tablets (a topic for another day) that they use their scarce resources to make unannounced inspections of certified physicians treating opioid addiction with buprenorphine, even though the DEA is not required to do so by law.

  • The manufacturer of the popular Suboxone Tablets recently took them off the market (in favor of their film version) citing mounting concerns of accidental pediatric exposure. And tried to get the FDA to block any future tablet versions.

The Probuphine implant cannot be diverted; cannot be stolen, sold or lost; cannot be abruptly stopped by the patient; carries no risk of accidental pediatric exposure; and cannot be accidentally overdosed. This new, safer form of buprenorphine appears to be the answer to many of the stated concerns of the CDC, DEA, ONDCP and the industry. Even more confounding, the rejection was not based on whether or not the medication is safe and effective or could save lives (which is undisputed and supported not only by the clinical trials of Probuphine but by a decade of clinical experience with buprenorphine); instead the rejection was based on superfluous details that could be resolved (if even necessary) post approval.

Here’s the additional information that the FDA insisted was needed before they can allow this medication to be available to save lives. A delay that requires further clinical trials could prove too expensive for the company and in effect kill the drug.

  • -The ability of Probuphine to provide opioid blockade of relevant doses of opioid agonists

    Buprenorphine’s ability to block the effects of other opioids is a secondary benefit, not a primary attribute. The main purpose of buprenorphine is to stop cravings and withdrawal, not to block opioids. When dosed correctly and with cravings suppressed, the patient isn’t taking any other opioids which would need to be blocked. Unlike Naltrexone which primarily blocks opioids, buprenorphine has two much more significant effects: suppression of cravings and suppression of withdrawal.

  • -Human factors testing of the training associated with Probuphine's insertion and removal- they felt the training was inadequate

    Probuphine is implanted just below the skin in a 10 minute in-office procedure not much more complicated than inserting an IV. See for yourself.

    Importantly, the implant isn’t mandatory - nobody is forcing doctors who would be uncomfortable to insert the implants. Those physicians who do have the facility, proficiency, and inclination will gravitate to the implant. Probuphine may actually bring new physicians to addiction treatment; i.e. dermatologists, OBGYNs, and surgical specialists who are adept at the minor procedure to implant the buprenoprhine rods. Additionally, physicians have existing motivation to be competent at installing the implants (ethics and lawyers).

  • -The effect of higher doses of Probuphine, ideally doses more closely approximating the blood plasma levels associated with sublingual doses of buprenorphine of 12 to 16 mg / day

    This is probably the most valid of the concerns, but the reason there isn’t definitive data is partly because the absorption characteristic of the film (or tablet) vary from person to person. What they are asking for is more related to the inconsistent absorption characteristics of other products than to Probuphine which has much more consistent bioavailability from person to person. This is something that clinical experience would resolve as clinicians discover best practices and share the findings with colleagues, not something dictated by the FDA, at the expense of delayed approval.

The reasons to approve this medication are significant and this form of buprenorphine provides a unique tool to physicians that is not intended to replace current treatments, but will be a very helpful option to some patients with specific needs. Those needs include:

  • Patients who need to travel abroad. Some countries prohibit buprenorphine by law.

  • Truck drivers, flight attendants and others whose work requires that they travel. Currently they must now choose between treatment and their job since, monthly visits to the pharmacy may not be possible. (Although buprenorphine is a Schedule III medication, few physicians are willing to write refills to accommodate these patients.)

  • Some patients do not remain in treatment long enough to achieve sustained addiction remission. The Probuphine implant virtually assures medication compliance for at least the first 6 months of treatment, arguably the most important period.

  • Telemedicine is an emerging technology that can provide state-of-the-art care without the need for a physical visit to the doctor’s office. This technology is bringing addiction treatment to those in rural communities and those who may otherwise be unable to get to a doctor’s office or pharmacy on a regular basis. The Probuphine implant will help these patients and likely help expand efficient cost-effective telemedicine technology

  • The ritual of taking a medication daily can be a trigger in and of itself for some patients. A monthly trip to the pharmacy, opening the tablet bottle daily and taking daily medication can remind patients of active addiction making it harder to implement changes in behavior. The implant erases that trigger.

  • Patients with a history of diversion or non-compliance, or in a controlled environment, such as prison, could be treated with confidence.

Finally, reducing the probability of diversion might lead to policy changes and much greater access to treatment for all buprenorphine patients. By Federal law, certified physicians are limited in the number of opioid addicted patients they can treat with buprenorphine. Up to 30, at any one time, for the first year after becoming certified and then up to 100 thereafter. This artificial distortion to the supply of treatment has fostered a black market for those who cannot find treatment and have no choice but to self-medicate their addiction. This diversion is then misinterpreted as abuse and cited to support the existing rationing policy and to argue for even less access. The implant would greatly reduce diversion concerns and perhaps pave the way for repealing the current patient limits facing those seeking to end their addictions.

Although the FDA has recently approved other buprenorphine products, none fill the specific needs that the implant can, especially one that cannot be diverted, cannot be overdose on, cannot be stolen, sold or lost, cannot be abruptly stopped by the patient, and carries no risk of accidental pediatric exposure. Making buprenorphine treatment safer seems like something the FDA should be in favor of. This lifesaving tool should not be withheld from those who need it.

You Can Help: Please voice your opinion directly to the FDA and ask them to reconsider keeping this important new tool from those who would benefit. Here’s how

19 responses to “FDA protects us from lifesaving drug”

  1. Dr. Robert Ben Mitchell, D.O. Says:
    From: Dr. Robert Ben Mitchell, D.O.
    Office Based Opioid Treatment Program
    16375 NE 18th Avenue, Suite #310
    North Miami Beach, Florida 33162
    786 - 262 - 5750

    September 19, 2013

    To:    Janet Woodcock, MD
       Director, Center for Drug Evaluation and Research (CDER)
       Food and Drug Administration
       White Oak Complex
       Building 51; Room 6133
       10903 New Hampshire Avenue
       Silver Spring, MD 20993

    Re:    NDA 204442 for Probuphine for Subdermal Use

    Dear Dr. Woodcock:

    I run one of the largest SAMHSA regulated Office Based Opioid Treatment (OBOT) programs in Southeast Florida. In my opinion, Probuphine® a SHOULD BE BANNED by the FDA because of the following:

    1. Buprenorphine treatment for opioid dependence should be administered when, and only when the patient has cravings or withdrawal symptoms. That way, as they undergo counseling and behavioral modification, they can slowly wean themselves off this medication. Giving 24 hour dosing is "overdosing" the patient as they are getting round the clock administration of the drug even when they don’t have cravings and withdrawals which defeats the whole purpose of treatment. All you are doing with Probuphine® is keeping them dependent 24/7 on the buprenorphine for 6 months unnecessarily.

    2. If a person with Probuphine® under their skin is in a medical crisis that requires emergency treatment (i.e. - surgery) where pain medications would be medically indicated and appropriate, the Probuphine® will block the pain medications from providing effective relief. Even if removed from under the skin, these types of sub-dermal depot treatments usually leave 3 or more days of medication inside the skin tissue. Could you imagine have an emergency appendectomy and not being able to receive effective opioid analgesia for 3 or more days afterwards? You might as well skip the anesthesia during the operation as well.

    3. Anyone who thinks that subcutaneous insertion of Probuphine® will make it safe from diversion does not know the addict population very well. People who abuse opioids commonly inject and cut themselves, so digging under their skin to retrieve a 6 month supply of re-sellable opioids would be of little consequence to them. I find the concept of placing 6 months of medication out on the street with any patient a terribly bad idea.

    4. While any death, especially a pediatric one is regrettable, as documented by the Florida Department of Law Enforcement's annual reports on Drugs Identified in Deceased Persons, more people die on Ambien than on buprenorphine products each year in the State of Florida. In fact, except for Demerol, more people die annually on all other opioids (i.e. - oxycodone, hydrocodone, morphine, methadone, etc.) than on buprenorphine. Why this great concern over buprenophine when there isn't a peep about any of these other drugs which are far more dangerous and cause far more deaths?

    For the above reasons, I applaud the FDA for rejecting Probuphine® and I encourage them to continue rejecting it.


    (signed copies mailed September 20, 2013)

    Dr. Robert Ben Mitchell, D.O.
    16375 NE 18 Avenue, Suite, #310
    North Miami Beach, FL 33162
    phone: 786-262-5750

    Dr. Margaret Hamburg, Commissioner
    Food and Drug Administration
    White Oak Building One
    10903 New Hampshire Avenue; Room 2217
    Silver Spring, MD 20993
  2. Terry Says:
    Sorry, I totally agree with the FDA on this decision for personal reasons. I personally have experience with Buprenorphine and do NOT agree with any type of implant for buprenorphine. Everything I've read about the FDA's choice to not approve Probuphrine is correct to me. Remember, this is from personal experience....
    I can not support approval of this drug/implant.
  3. Maggie Haupt Says:
    I really think the FDA should reconsider the refusal of the new drug Probupine. I think it's the best thing that's come out since the suboxone pill years ago. I've been taking suboxone for years. I live in Broome County New York and its so hard to find a doctor in this area. I'm going to the doctor once a week and its such a pain in the butt. I have 3 young boys from the age of 7 to 1 month. It does worry me that my kids might get in the script but honestly it's the least of my worries. I want to find a doctor that will keep me on suboxone for a while because its a miracle drug for me. Not only have I been clean since 2007 but I don't even think about getting high AT ALL! It completely motivates me and makes me who I want to be a clean and sober mom and wife that's takes care of her family. This new drug would be unbelievable if it got out onto the market. There's such a market for suboxone out there and there would be no more illegal sales of it on the street. I think it would make those who buy it off the street go find a doctor themselves. I think it would help in so many different ways. I just think you should consider all the options first before you just overlook the goodness it could do for soooo many people. The FDA wouldn't have to look into these doctors so much, they wouldn't have these drug sales, the patient couldn't stop taking it for at least 6 months so they can't get high. There's so many more reasons out there. I just strongly disagree with your decision and strongly strongly hope you reconsider the greatness this could do for so many different people's sake. Thanks
  4. NAABT Says:
    Response to: Dr. Robert Ben Mitchell, D.O. comment above

    I can understand a physician choosing not to prescribe a particular drug for some reason, but to deny the same option to other physicians who want to prescribe it is perplexing. If opposed to it, don’t use it, but don’t go out of your way to deny its benefits to others.

    1)   Your philosophy of addiction treatment (at least as indicated above) is entirely contrary to the current body of evidence. The purpose of buprenorphine treatment is precisely to provide steady suppression of cravings and withdrawal thus enabling the patients to make long-term behavioral changes. By administering buprenorphine only when patients are suffering and craving, you may be activating the craving/reward cycle and reinforcing the addiction instead of helping. It’s the repetition of the craving/reward cycle which alters the brain making the reflex reaction to pain/stress/and anxiety to seek the reward-providing substance. Buprenorphine, when administered correctly, stops that cycle and allows the patients to break the pain/reward association through deliberate behavioral changes. See the purpose of buprenorphine treatment
    and Neurobiology of addiction

    2)   Your argument is not specific to the implant but applies to all buprenorphine products since all of them have effects that can last days after administration. In the rare event of unanticipated acute pain, where opioid medication may be required, as you mentioned the rods can be removed. Although buprenorphine can block most opioids days after administration, certain opioids can be used in higher than normal doses and monitored closely until the remaining buprenorphine metabolizes and opioid medication becomes full y effective. Plus it’s important to note that buprenorphine is itself a potent analgesic and often given in hospitals in injection form (Buprenex) to treat postoperative pain, making removal of the rods unnecessary in some cases. Clearly the know risks from untreated opioid addiction (death) outweigh the unlikely inconvenience of the need to treat unanticipated acute pain.

    3)   This offensive stigmatizing generalization overlooks an important aspect of the implant. Due to steady-state constant administration of medication and better absorption with direct blood contact of the implant, much less medication is required when compared to tablets or film. In fact each rod contains only 80mgs of buprenorphine. With 4 rods expected as the typical dose, that’s 320mgs total for the six month period. In contrast, 6 months of tablets or film at the typical dose of 12mgs/day = 2,160mgs. Clearly the much lower amount of medication (6.7 times less) coupled with the deterrent of a painful extraction process and the formidable obstacle of chemically separating the buprenorphine from the rod matrix, makes the implant considerably less of a diversion concern. Anyone intent on selling their buprenorphine will avoid the implant like the plague. In fact it’s more a remedy for suspected diverters than a significant diversion risk itself.

    4)   I too am surprised that the safety record of buprenorphine is not lauded given how few deaths have occurred when compared to other opioids or even common OTC drugs. Still, according to the CDC, a disproportionate amount of children are exposed to buprenorphine than to other more widely prescribed opioids. In situations where physicians sense a high risk to children, having this option available can only be a positive prospect and physicians should not be denied this option.
  5. Dr. Robert Ben Mitchell, D.O. Says:
    Response to NAABT:

    To your point 1: I strongly disagree. The point of treatment is to use buprenorphine if and only if there are cravings or withdrawal symptoms. This "only if" method provides coverage when needed while providing an automatic mechanism for self-weaning when the patient is ready. Twenty-four hour dosing totally defeats this goal.

    To your point 2: Eight mg of oral Buprenorphine has the analgesic capacity of about 800 mg of oral ibuprofen. At best it is good for mild to moderate pain. For severe, post-operative pain it would be totally inadequate and it would block other, more effective analgesics.

    To your point 3: Pain is no deterrent to many of my patients. Eight mg of buprenorphine sells for upwards of $30-40 on the street. With each rod having 80 mgs, that's $300-400 per rod, or $1200-1600 per extraction of 4 rods. There are many addicts who would gladly endure the pain involved in extracting 4 rods for a $1600 pay day. And, if the average street person can turn Sudafed into meth-amphetamine, they'll surely figure out how to extract the buprenorphine from those rods.

    4. Buprenorphine has a great track record as an sub-lingual treatment for opioid dependence. Oxycodone once had a great track record too, until it was introduced as Oxycontin. I don't want to see this kind of far reaching, tragic mistake made with buprenorphine. Probuphine should remained banned by the FDA.
  6. NAABT Says:
    Response #2 to: Dr. Robert Ben Mitchell, D.O.

    1) Although cravings are undeniably part of the initial diagnosis criteria and would certainly exist prior to the start of treatment, once treatment begun, the cravings and withdrawal should NOT reemerge. Suppressing the cravings so they don’t distract the patients from making behavioral changes is the whole point of the treatment. The brain changes associated with addiction cannot be reversed while the craving/reward cycle is active. In the last 10 years I have never encountered another physician with a similar view to yours. Clearly we have no hope of agreement on this point.

    2) From the Official FDA Buprenex label link posted above- “Buprenex is indicated for the relief of moderate to severe pain”, and from the TIP-40 (page 6) - “At analgesic doses, buprenorphine is 20–50 times more potent than morphine” But this is a moot point anyways; because your alternative is no buprenorphine i.e. untreated addiction while the patient anticipates an unlikely acute pain event. We know untreated opioid addiction has a high mortality rate. So the risk of likely death weighed against the risk of an unlikely pain episode, clearly should lead to a decision to treat the addiction with buprenorphine, and deal with any acute pain situation should it ever occur.

    3) Using your figures and assumptions, don’t you think a patient intent on diversion would chose $8100 ((12mgs/day(tablets or film) X 180 days)/8mgs X $30) over the $1600 payday from selling the implants? Again, why would any diverter agree to an implant when tablets and film are available? Plus, removing the implant is a one shot deal for diverters, they can’t go back to the doctor for another one, because with no record of removal the diversion is exposed. Lastly, $1600 would satisfy maybe 2 weeks of active addiction, what will they do for the next 24 weeks, now that relief from the implant is eliminated?

    4) Isn't it clear that Probuphine is substantially LESS likely to be diverted than tablets or films? From your own argument you should be in favor of it. It’s providing 320mgs of possible diverted buprenorphine every six months instead of 2160mgs of the tablets or film. Now add in the deterrent of pain of digging it out of the skin and chemically extracting the buprenorphine and you must agree that would translate to LESS buprenorphine on the street not more. Based on the facts I can’t understand how anyone could conclude that Probuphine is a greater diversion risk than film or tablets.

    Respectfully; I think in your original response you were unaware of just how little buprenorphine was actually in the implants. I think you should reexamine the evidence and reconsider your position.

  7. Brett Martin Says:
    This is a response to Dr. Ben Mitchell's September 19th published response to Probuphine. I respect freedom of speech; however, I am concerned about Dr. Mitchell's first point that Suboxone should be taken symptomatically only when cravings or withdrawal are present. Readers, PLEASE be weary of this assertion. Do your own research and see what the body of evidence says, and see how these medications were intended to be used. As I said earlier, I respect freedom of speech, but please understand that Dr. Mitchell's personal view is not the standard of care. Buprenorphine medications used for maintenance therapy are the standard of care for opioid dependence today.
  8. Ethical MD Says:
    I agree with the doctor. Since adding Suboxone treatment to my practice I have never experienced such a deceptive and manipulative group of patients. I too believe that such people are not above carving into their own flesh for some extra cash. The idea that six month doses of buprenorphine are appropriate defeats the point of any type of structured care for the addicted who need to be managed closely throughout the course of their medical management. Take for example an addict who gets some benzodiazepines or other illicit substances during bup treatment. Treating an addict with depot buprenorphine is akin to handing a thief a bag of money so they won't steal.
  9. NAABT Says:
    "Ethical MD",
    It’s so disheartening to read the stigmatizing generalizations you make of buprenorphine patients. Such attitudes make it harder for people to seek treatment and less likely for doctors to want to treat addiction. This is another reason why we don’t need patient limits or restricted access to care, because it limits patient’s choice making it difficult or impossible for them to shop around and choose a more compassionate provider.

    But beyond the stigmatizing characterization, your logic is flawed. Although it is certainly possible for someone to dig an implant out of their arm, it is far less likely than simply selling a bottle of tablets or film as is the current option. Plus, despite the fact that an implant provides six months of treatment, it only contains the equivalent of one month of buprenorphine. The steady dose administration and the better bioavailability mean much less buprenorphine is required. Each rod contains 80mgs of buprenorphine, 4 rods are thought to be a typical dose and equivalent to 12-16mgs/day of film or tablet. Do the math and you’ll find the typical implanted dose contains 320mgs of buprenorphine while six months of tablets or film amount to 2160mgs – 2880mgs. You’re telling me that 320mgs imbedded under the skin is a greater diversion risk than 2160mgs+ of convenient tablets or film? Clearly you haven’t thought this through.

    Additionally, the implant doesn’t absolve physicians of good judgment. Not all patients would be appropriate for the implant especially those who, as you point out, need frequent observation, therapy, monitoring, or whatever needs they may have. Providers would have to make judgments on who is appropriate for the implant LIKE THEY DO WITH EVERY OTHER MEDICATION. Citing inappropriate patients as reason to withhold this new tool from appropriate patients is an invalid argument.

    A possible dosing strategy might be to implant one rod and supplement with tablet or film. Clinical experience has shown that as patients stabilize they require less buprenorphine. Such a strategy could ensure patients return for monthly supplement prescriptions and therapy, while providing a minimal level of craving suppression for six months, improving the odds of compliance, and survival. Currently more than 2/3 of patients drop out of treatment within the first 6 months.

    How can you dismiss the benefits of the implant;
    •   no risk of pediatric exposure,
    •   no buprenorphine dosing errors,
    •   no lost or stolen medication,
    •   6 months of medication compliance,
    •   ability for patients to travel,
    •   elimination of the tablet-taking ritual (which might be a daily reoccurring trigger for some, as may be trips to the pharmacy),
    •   6 times less mgs of buprenorphine dispensed (if diversion really is the concern)

    …and the added deterrent of - digging it out of the skin- risking infection and relapse – chemically extracting the buprenorphine- while burning the bridge with the doctor who provided the implant, as with no record of removal the diversion is exposed and the patient is unlikely to receive further treatment from that doctor. Isn’t it clear that diversion, although possible, is extremely less likely with the implant than with current tablets or film?

    More structure is not always appropriate, actually the opposite is true, highly structured treatment was already available through methadone clinics. Buprenorphine was developed as an alternative to the highly structured environment of the clinics offering less structure and prescriptions instead of daily dosing. It worked; 3 times the number of patients are in medication-assisted treatment now than before buprenorphine was introduced.

    A cynical view (not accusing you) might be that some physicians want to preserve the status-quo and are averse to risking the loss of monthly (or even more frequent in some cases) office visits at $500/visit plus.
  10. s Says:
    my child has suffered from addiction for years. with no insurance, taking into consideration that suboxone clinics are in fact only a rip off and the only thing that works is subutex, which is impossible to get a script for, i think that the new medication implant would be a Godsend! But the government doesn't really "want" to help anyone except themselves, that is to fatten their already bursting pocketbook.
  11. s Says:
    well of course it won't be made public until its approved; maybe the moderator is paid by the gov to only print the positive comments and not the real ones?
  12. Brett Martin Says:
    Again in response to another doctor’s response to Probuphine, “Ethical MD” as you identify yourself. I do not understand why you would want to have patients in your practice that are deceptive, manipulative, and akin to thieves (your words). Unfortunately this debate was to be about a new delivery system for a medication that you admit that you prescribe in your practice. However, you have turned on your patients and are blaming them for your reason not to support the new delivery system. Shame on you!

    I believe I understand some of the same problem you see in a six month implant. If an opioid dependent patient receives a Probuphine implant, what happens over the next six months? From an MD standpoint, I can understand the concern that these patients can’t be monitored appropriately. This is just not true. Buprenorphine is meant to be prescribed along with treatment and therapy. The opioid dependent patient receiving agonist therapy should be involved with some type of a treatment program. Their progress can and should be monitored throughout this program. I work in such a program. Our opioid dependent patients receiving buprenorphine are required to be in a treatment program. Utilizing the ASAM patient placement criteria our patients may be in an inpatient program, Intensive Outpatient program, or Outpatient program, but will always be at least in outpatient settingas long as our psychiatrist is prescribing buprenorphine.

    Next we must address the elephant in the room. If Probuphine is approved, many current buprenorphine prescribing physicians will lose a tremendous revenue source. Buprenorphine patients will no longer need to be see weekly, biweekly, or monthly, instead once every six months barring in complications. This will hurt the pocketbooks of many doctors.

    Lastly, I must let “Ethical MD know that I take offense to his/her improper characterization of opioid dependent patients. I am an Addictions Professional and have been since 2003. More importantly I am a recovering addict and have been for over 17 years. Please stop seeing opioid dependent patients if you truly feel they are deceptive, manipulative and akin to thieves. You will only do more damage.

    Probuphine is buprenorphine with a new type of delivery system. There are some valid concerns over the 6 month implant. Our own staff is wrestling with the patient’s accountability portion of these concerns. I do believe that we as a staff can develop program polices and treatment rules to minimize most risk. We are also aware that a 6 month implant will not be appropriate for all.

    Brett Martin
    Certified Addictions Practitioner
  13. Dr. James McCrary, D.O. Says:
    Dr. Mitchell get real. I agree with all NAABT responses to your comments. Shame on you.
    Ethical MD, most of us know exactly what you mean but you went to far!
    We all need to wait to see what the FDA does in the end, this is not our first rodeo......
  14. Brett Martin Says:
    I have been following this topic for some time now. I have been baffled by some of lack of understanding of the disease of addiction. I have not been able to understand some of the perspectives of others above, but ran across and article today that made some sense of it. I would like to share a link to it. It is from the Addiction Professional Magazine. Here is the link.

    Brett Martin
  15. Todd Says:
    I will try to stick to the main question at hand but first I have to make a few quick points.

    NAABT - I would expect better comments that show understanding of pharmacology basics and do not confuse the lay person like forum posts on other sites tend to: “At analgesic doses, buprenorphine is 20–50 times more potent than morphine”. This is not a statement to support the drugs "pain-killing" ability. As I am sure you know "potency" is used to describe the point i.e. mg, mcg, etc drug 1 and drug 2 provide equal analgesia (though still subjective) and has nothing to do with the actual pain killing ability of the drug.

    We all know the drug received a "moderate to severe" rating when initially approved and Product Inserts (PI) tend to be written in stone with changes being increases in caution, not decreases. Most also know that, the majority of the population was drug naive to buprenorphine ,in the US, at the time of approval and in those patients very small doses DO provide mod-sev pain relief, but a majority of the time as is with most opioid dependent patients an increase in the drug (or change in freq) that they are dependent on will not be a very good analgesic (due partly to psycology of it) in a pain emergency.

    - Inserted as a PSA: ER docs, if presented with a bup patient a few drugs DO (hint:oxymorphone IV) have a higher affinity than bup and can be used at moderate dosing with many drugs able to be use at much larger dosing (but between the DEA and the real valid fear physicians have of them I doubt good pain control will be available when needed in an emergency either way).

    Now, related to NEW delivery and such...

    Anything to increase the number of patients able to be treated by "real", "interested" and "compassionate" physicians is a good thing in my book. I think the sad state of medicine in the US today (with the pipe-dream "free ride" being sold by politicians currently) many doctors are searching for revenue streams just to survive. Some with strong, uninformed opinions about those addicted and in my opinion should not be in this business because they miss the most important point. We use to have to wait till the addiction cost the patient "everything" and then put them in a prison like methadone program that does not seek to make them drug free. From that aspect we have come far, very far.

    Do not forget that this is a nasty business all around and the least sneaky people (although we all understand his points, but very one-sided) tend to be the patients. Case and point, we (our taxes) funded the creation of buprenorphine which then was held hostage by a company that finally went too far in lets just say, creative statistics and lost their disgusting battle to remain the only place in town, and won themselves a FDA request to the FTC for a criminal investigation. We finally have the market open and once the prices settles, more can be treated. The mad rush for the next patented money-making delivery system can wait, don't you think that these patient have been used enough so far? They are one of the most vulnerable populations and companies seek to monopolize on them. Before you think I am an anti-pharma kind of person, I have spent 15 years defending the prices of new medications due to the costs to bring to market but more recently I have seen how blood thirsty the best of intention companies can get when they see a possible end to new drug discovery on the horizon...totally off topic now. Sorry.

    Simple fact, the NDA was deficient in critical ways, and it is my job to have an opinion (take it for what it is, everyone has one, but mine is informed as to the real process and sometimes unexplainable decision making at the FDA).
    I do what I do to make drugs that can help people but have acceptable risk profiles. Basic research on this product (implantable bup) is missing. We have a history of horrible consequences with implantable rods. We have the FDA not even admitting the real actions of the two drugs in Suboxone and still stating the company line about opiate blocking and such. We also have some problems starting to surface from long term use of Suboxone (post marketing is when you actually find out if the drug has long term or different population problems - funny when I started in this industry post marketing studies where not required...less than twenty years ago!). Other governments raised concerns about the do no harm aspect of adding naloxone for little reason and exposing the population to it unnecessarily. It is not a benign drug and yes it is absorbed in significant amounts to be a concern, especially when treated as an excipient if not crushed and injected. I would hate to see the baby thrown out with the bathwater if it turns out that it is the naloxone causing the memory loss and headaches and they just lump the bup in with it. Lets get our ducks in a row and learn from what we now know. If you think that this bup treatment is a solution (being utilized like it should be) just do a dr. finder request and see how many physicians are willing to see you at the standard rate(although some increase is fair with the restrictions placed on amount they can see, especially year one. But $2000 to be seen, right...)

    I say no to the implant and sorry I usually am a big fan of what this site has to say (and I understand that legally you may have some hands tied about drug claims). This is another in a string of "abuse-reducing" drugs that have, for the other ones i.e. Oxycontin, been a huge failure. Plus if you think the DEA and the FDA are using any kind of logic in all this just look at the recent Opana mess. Now we have a drug in generic form that can OD someone very easily, with no other drug out there with such a difference in ROA and absorption. A drug with oral bio-availability of 10% yet after crushing the generic 40mg you have up to 80% (I know the data varies but 60%-80% still kills when someone does not know)absorption if sorted "gently", to keep as much in the sinuses as possible. Eight times the strength, just for comparison oxycodone was less bio-available when snorted. We now have a drug that can cause IV like overdoses with snorting.

    Buprenorphine, used properly by educated physicians that stay up to date on the data being seen in real practice and understand they are treating a dangerous, very likely deadly a great tool. Lets expand its proper use first.

    Thank you for your time.
  16. Terry Says:
    Response to the other Terry who states he agrees with FDA and is opposed to buprenorphine for personal experience reasons: Terry, I absolutely respect your right to your personal opinion; however, I too have personal experience with buprenorphine and it has helped me immensly. I don't think one's personal experience though should be extrapolated to suggest that everyone out there that has this terrible problem shouldn't be allowed buprenorphine based on 1 person's bad experience, nor should my positive experience either. Nor should the police state determine what is good or bad; their perspectives are highly skewed based on all the negative aspects of society they have to deal with every day, and they don't often get to experience those of us who follow the rules. We need to let the medical professionals and their individual and separate patients determine what works best for each individual. I pray for quick approval of Probuphine.
  17. Terry Says:
    In response to those above who are opposed to Probuphine and condemn buprenorphine, such as 'Dr. Mitchell' and the other anonymous 'Ethical MD', instead of condemning the medication and your purported patients, do you have any solutions to offer?

    You seem to want us to suffer. Should we all be jailed and forced to do hard labor, how about putting us in front of firing squads? Not all of us started down this path of dependence by partying with drugs. Some of us had underlying painful medical conditions, and the opioids that were prescribed didn't work well and after a period of time we found we got ourselves in a bind. For me, buprenorphine hasn't resulted in tolerence problems like the full agonists did, yet the pain from my underlying medical condition is under control. I've never cheated or lied to my doc, I've never diverted any of my prescription. I work 50+ hours a week, attend Church, pay taxes and am raising a family. Why do you want to deny me treatment? Do you have an alternative solution?

    No matter what laws are in place, no matter what you do, society will always have a certain percentage of non-compliant people. Thousands more die every year from heart attacks, strokes, diabetes, etc. than from overdoses of opioids, why don't you condemn their prior bad choices in life; junk food, soda,and cigarettes that lead them to their current conditions and deny their blood pressure and other meds for these conditions?
  18. Dr.Al Says:
    So, Im an Norwegian addict. I would like this 6 Month sub solution. Im coming right over the pond if you guys could just stop fighting about it. This is great, another solution to this addiction problem. For me, I can travel, and stay extensively in other regions of the world, trust me, this would be a life-saver. FDA, please approve it.
  19. Addiction Provider MD Says:
    I was curious to see if anyone has heard any other relevant information regarding this drug. I am interested to see the results of the ongoing trial once released.

    I know this has been beaten to death on this site, but I am firm proponent of this drug. When used in the Appropriate patient population, I feel this will be a huge benefit and additional tool. Suggesting that it is "all or nothing" or a stand-alone, day one treatment option, makes no sense. I feel you are just distracting here from the real argument. Most of my patients who take suboxone like a drug ie. taking it when they need a fix, never get better. They can't break the cycle of craving and response to craving. This will seem to overcome that problem.

    I also have noticed that my patients who want to get high... do not actually take the suboxone. In my opinion, the partial agonist effect of the medication prevents the full effect from their other drug of choice. Ensuring the patient is Actually taking the medication is often the first hurdle I face when working through a treatment algorithm.

    Diversion can be very difficult to detect in the current treatment atmosphere. It seems to reason that diverting this rod will be Very easy to detect, and solve another major hurdle.

    Your assertion that some of your patients are just going to 'show up' to your office for the first time and receive an implant seems outlandish. Obviously you will need to start a patient on pills or films and Figure out what their dose is, and then transition them to an implant if they are able to be stabilized and deemed to be reasonably stable and potentially reliable. You can eyeball them real hard and ask yourself if they plan on dicing up their arm later or not... rocket science. I would assume that anyone asking for an implant is less likely to divert to begin with... but that is clearly my own opinion.

    Anyone can do anything with any medication. I am a lot more worried about an addict selling their suboxone to an opiate-naive person or having it fall into the hands of a child. I think I would sleep better knowing that someone will have to cut something out of their arm, attempt to alter it, (and then likely never come to my office again to continue the diversion process)... to cause another human being accidental harm. It seems like much less of a tragedy than a strip of suboxone being accidentally found by an honest addict's child.

    The only realistic drawback that I see to this medication would be the point that is mentioned regarding the continued effects of opiates when someone is sick from another illness. In this regard it seems very reasonable to obtain more data about training procedures and policies for removal.

    Your point that someone would undergo an appendectomy and still be in pain due to the dosing of a suboxone-like medication is outrageous. I am also an ER attending. I am typically able to overcome the partial agonist effects and obtain adequate analgesia in a suboxone patient with higher dose morphine or a reasonable dose of fentanyl (when needed). It sounds like you have little experience in the acute treatment of pain in the addicted population, or that you are simply trying to scare people.

    There are many different types of addicts, it seems odd to insist on one variety of treatment. This seems like an ideal option for working-class, motivated people, who have demonstrated compliance and commitment to attaining sobriety. Walking into a real job every day and pulling opiate strips out of your pocket and risking misplacing them or being inadvertantly discovered as an addict seems like a very unnecessary risk when compared to this treatment option.

    I was curious if your opinion has changed any regarding this treatment option, or if you are still on the bandwagon of the failed current treatment approach. And I do emphasize failed. Google success rates (and diversion rates ha!) of our current modalities if you doubt me.

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The Purpose of Buprenorphine Treatment:

To suppress the debilitating symptoms of cravings and withdrawal, enabling the patient to engage in therapy, counseling and support, so they can implement positive long-term changes in their lives which develops into the new healthy patterns of behavior necessary to achieve sustained addiction remission. - explain -

The National Alliance of Advocates for Buprenorphine Treatment is a non-profit organization charged with the mission to:

  1. U.S. Food and Drug Administration, FDA Talk Paper, T0238, October 8, 2002, Subutex and Suboxone approved to treat opiate dependence.
  2. Center for Substance Abuse Treatment. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series 40. DHHS Publication No. (SMA) 04-3939. Rockville, Md: Substance Abuse and Mental Health Services Administration, 2004.
  3. Subutex Discontinued in the US market in late 2011.
  4. Zubsolv (bup/nx sublingual tablet) FDA approved 7/3/2013 see buprenorphine pipeline graphic -in pharmacies now.
  5. Bunavail (bup/nx bucal film) FDA approved 6/6/2014 see buprenorphine pipeline graphic -in pharmacies now.
  6. Probuphine FDA approved 5/26/2016 - FDA Probuphine press release