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FDA Approves Two Forms of Buprenorphine for Opiate Treatment

The U.S. Food and Drug Administration (FDA) has approved two versions of the drug buprenorphine for treating opiate dependence. Like methadone, buprenorphine can be used to treat dependence on opioid-based prescription drugs, such as OxyContin and various pain medications, as well as illicit drugs like heroin. But buprenorphine is subject to less-stringent government regulation than methadone, meaning doctors may be more willing to prescribe it to patients.

"It will still be a while before addiction medicine is truly mainstream, but this is the first step in moving towards that, and also in people understanding that addiction should be treated medically," said Joycelyn Woods, president of the National Alliance of Methadone Advocates (NAMA). "For 30 years, doctors have not able to treat addiction, so in that respect it's really a step forward."

The FDA announced on Oct. 8 that it has approved Subutex (buprenorphine hydrochloride) and Suboxone (buprenorphine combined with naloxone) for prescription and sale in the U.S. Buprenorphine is the third anti-opiate medication approved for use in the U.S., joining methadone and LAAM (Levo-Alpha-Acetyl-Methadol). Buprenorphine is less powerful than methadone but is considered to be somewhat safer and causes fewer side effects, making it especially attractive for patients who are mildly or moderately addicted. Buprenorphine is a partial opiate agonist: it blocks withdrawal and craving without producing a strong narcotic high. The FDA said Subutex should be used at the beginning of treatment, while Suboxone should be used for maintenance.

Immediately after FDA announced its approval of buprenorphine, NIDA and the Substance Abuse and Mental Health

Services Administration (SAMHSA) officially unveiled the certification and training program for physicians who want to prescribe buprenorphine -- a project that actually has been going on quietly for months.

Under the DATA law, physicians are required to have a minimum of eight hours of training to prescribe buprenorphine, and must obtain a waiver from the DEA. Physicians who are already certified as addiction specialists are exempt from the training requirements.

So far, doctors who already specialize in some form of addiction medicine, such as members of ASAM and the American Academy of Addiction Psychiatry, have been the ones most interested in buprenorphine. To spread the word more widely, SAMHSA will hold a series of informational meetings for physicians, and has set up a website and toll-free number for doctors to find out more about buprenorphine (866-BUP-CSAT).

For buprenorphine to make a real dent in opiate addiction, general practitioners need to buy in. For now, that remains one of the biggest question marks about the drug's long-term impact on opiate addiction.

Taken from Join Together On-line (www.jointogether.org)

Join Together is a project of the

Boston University School of Public Health