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
Timeline of buprenorphine products past, present, and future
Orexo receives FDA approval for Zubsolv (buprenorphine/naloxone sublingual tablets) launched in September 2013
UPDATE: In pharmacies now 11/2014 – press release BioDelivery Sciences International, Inc. files NDA with the FDA for BUNAVAIL (Bup/Nx buccal soluble film) 7/31/13.
Probuphine delayed 1-2 years
Titan Pharmaceuticals, Inc. – 3/21/13 – FDA Advisory Committee recommends approval of Probuphine (long-acting, subdermal buprenorphine implant)
UPDATE – April 30, 2013 FDA says NO!
February 25, 2013
Actavis receives FDA approval 2/0.5mg and 8/2mg sublingual buprenorphine/naloxone tablets (GnrBupNx2 )
February 25, 2013
Amneal Pharmaceuticals receives FDA approval 2/0.5mg and 8/2mg sublingual buprenorphine/naloxone tablets (GnrBupNx1 )
August 20, 2012
Reckitt Benckiser Pharmaceuticals Inc. receives FDA approval for Suboxone Film 4/1mg and 12/4mg (sublingual buprenorphine/naloxone)
September 24, 2010
Hi-Tech Pharmacal Co. receives FDA approval for sublingual buprenorphine tablet (GnrBup3 )
August 31, 2010
Reckitt Benckiser Pharmaceuticals Inc. receives FDA approval for Suboxone Film 2/0.5mg and 8/4mg (sublingual buprenorphine/naloxone)
July 7, 2010
Perdue Pharma L.P. receives FDA approval for Butrans 7-day transdermal buprenorphine patch
May 25, 2010
Teva Pharmaceuticals USA Inc. receives FDA approval for sublingual buprenorphine tablet (GnrBup2 )
November 1, 2009
Midlothian Laboratories receives FDA approval for sublingual buprenorphine tablet (GnrBup4 )
October 8, 2009
Roxane Laboratories receives FDA approval for sublingual buprenorphine tablet (GnrBup1 )
October 8, 2009
Reckitt Benckiser Pharmaceuticals Inc.’s Orphan Drug Marketing Exclusivity for Suboxone and Subutex expires
December 29, 2006
DATA-2000 amended to allow 100 patients per physician certified for more than one year
August 2, 2005
DATA-2000 amended to allow 30 patients per physician in group practices – instead of 30 per practice
October 8, 2002
Reckitt Benckiser Pharmaceuticals Inc. receives FDA approval for Suboxone (sublingual buprenorphine/ naloxone) and Subutex (sublingual buprenorphine)
June 30, 1985
Reckitt Benckiser Pharmaceuticals Inc. receives FDA approval for Buprenex (0.3 mg/ml IM injectable buprenorphine)
March 18, 1969
Patent #3,433,791 issued for buprenorphine
This page was last modified on. 11/09/2014
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:
- Educate the public about the disease of opioid addiction and the buprenorphine treatment option.
- Help reduce the stigma and discrimination associated with patients with addiction disorders.
- Serve as a conduit connecting patients in need of treatment to buprenorphine treatment providers.
- U.S. Food and Drug Administration, FDA Talk Paper, T0238, October 8, 2002, Subutex and Suboxone approved to treat opiate dependence.
- 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.
- Subutex Discontinued in the US market in late 2011.
- Zubsolv (bup/nx sublingual tablet) FDA approved 7/3/2013 see buprenorphine pipeline graphic -in pharmacies now.
- Bunavail (bup/nx bucal film) FDA approved 6/6/2014 see buprenorphine pipeline graphic -in pharmacies now.
- Probuphine FDA approved 5/26/2016 – FDA Probuphine press release