The Food and Drug Administration (FDA) has approved Buprenex® ( an injectable formulation of buprenorphine) and Butrans® (buprenorphine transdermal patch) to treat pain. However, by law, Buprenex and Butrans cannot be used to treat opioid dependence(addiction), even by DATA-2000 wavered physicians. Buprenorphine: Considerations for Pain Management (study)
Buprenorphine has also been found to relieve refractory depression, but this particular use has never been approved by FDA. Refractory depression is depression that has not responded to other treatments. Some patients, who suffered from depression in the past, have experienced relief of symptoms on buprenorphine. (Bodkin,1995)
FDA has approved Subutex®( buprenorphine) and Suboxone® (buprenorphine/naloxone) to treat opioid dependence (addiction). However, neither Suboxone nor Subutex has been approved by the FDA for the treatment of depression or pain. Thus any use of Suboxone® and Subutex® for pain or depression is considered an off-label , unapproved use of these medications.
The D.E.A. articulates policy on the use of buprenorphine for pain and other off-label uses of buprenorphine products under DATA2000. Letter to Doctor Heit
Clarification: Buprenorphine is intended for the treatment of pain (as, Buprenex®) and opioid dependence (addiction) (as, Suboxone® and Subutex®). In 2001, 2005,and 2006 the Narcotic Addict Treatment Act was amended to allow qualified physicians, under certification of the DHHS, to prescribe Schedule III-V narcotic drugs (FDA approved for the indication of narcotic treatment) for narcotic addiction (up to 30 patients/physician at any time, 100 for those who meet certain criteria) outside the context of clinic-based narcotic treatment programs (Pub. L. 106-310). Suboxone®, Suboxone® Film, Subutex® (and any generic equivalents) are the only treatment drugs that meet the requirement of this exemption (not Buprenex® or its generic equivalents). Source: DEA
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 -