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The National Alliance of Advocates
for Buprenorphine Treatment

Buprenorphine (Suboxone®, Subutex®3, Zubsolv®4, Bunavail™5, Probuphine®6) 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

Treatment Law

A significant breakthrough in the treatment of opioid addiction occurred with the introduction of methadone in the 1960s. Methadone maintenance proved safe and effective and enabled patients to lead functional lives, something that was often not possible using only drug-free approaches. Within a few years of its introduction, however, new laws and regulations in the United States, including the Methadone Regulations and the Narcotic Addict Treatment Act 1972-1974, effectively limited methadone maintenance treatment to the context of the Opioid Treatment Programs (OTP) i.e., methadone clinics. These laws and regulations established a closed distribution system for methadone that required special licensing by both Federal and State authorities.

Efforts to return opioid addiction treatment to the mainstream of medical care began to take shape and gain momentum in the 1990s.

The new system made it very difficult for physicians to use methadone to treat opioid addiction in an office setting or even in a general drug rehabilitation program. To receive methadone maintenance, patients were required to attend an OTP, usually on a daily basis. The stigma and inconvenience associated with receiving methadone maintenance in the OTP setting led, in part, to the current situation in the United States in which it is estimated that fewer than 25 percent of the individuals with opioid addiction receive any form of treatment for it (National Institutes of Health 1997). Another result of the closed distribution system was that most US physicians were prevented from gaining experience and expertise in the treatment of opioid addiction.

Efforts to return opioid addiction treatment to the mainstream of medical care began to take shape and gain momentum in the 1990s. In October 2000, the Children's Health Act of 2000 was enacted into law. Title XXXV of the Act provides a "Waiver Authority for Physicians Who Dispense or Prescribe Certain Narcotic Drugs for Maintenance Treatment or Detoxification Treatment of Opioid -Dependent Patients." This part of the law is known as the Drug Addiction Treatment Act of 2000. (

Under the provisions of DATA 2000, qualifying physicians may now obtain a waiver from the special registration requirements in the Narcotic Addict Treatment Act of 1974, and its enabling regulations, to treat opioid addiction with Schedule III, IV, and V opioid medications that have been specifically approved by FDA for that indication, and to prescribe and/or dispense these medications in treatment settings other than licensed OTPs, including in office-based settings. On October 8, 2002, two new sublingual formulations of Buprenorphine – Subutex® (Buprenorphine) and Suboxone® (Buprenorphine/naloxone) – became the first and, as of this writing (1/4/2007), the only Schedule III, IV, or V medications to have received this FDA approval.

To qualify for a DATA 2000 waiver, physicians must have completed at least 8 hours of approved training in the treatment of opioid addiction or have certain other qualifications defined in the legislation (e.g., clinical research experience with the treatment medication, certification in addiction medicine) and must attest that they can provide or refer patients to necessary, concurrent psychosocial services.

Physicians who obtain DATA 2000 waivers may treat opioid addiction with Subutex or Suboxone in any appropriate clinical settings in which they are credentialed to practice medicine. The promise of DATA 2000 is to help de-stigmatize opioid addiction treatment and to enable qualified physicians to manage opioid addiction in their own practices. This greatly expands currently available treatment options and increases the overall availability of treatment.

see 30/100 Patient limit page for amendments to the DATA2000 law.

see our timeline of laws concerning opioids and treatment

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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