FDA
Approves
Buphrenorphine
for
Home
Addiction
Treatment
10/11/02
The US Food and Drug Administration (FDA) approved the use of the narcotic pain reliever buphrenorphine for the treatment of heroin addiction Tuesday. Buphrenorphine blocks the euphoric high of heroin while staving off withdrawal symptoms because it is an opioid. The drug could become a widely used alternative to methadone maintenance. Unlike methadone, which is dispensed at clinics operating under cumbersome federal restrictions, buphrenorphine will be available by prescription from specially licensed doctors. In other words, heroin users who wish to treat themselves with buphrenorphine will be able to go to a doctor's office, not a clinic, and be prescribed medicine from a pharmacy to be taken at home. The Drug Addiction Treatment Act of 2000 laid the legal groundwork for the shift to home treatment of addiction, which is expected to increase the number of heroin users seeking freedom from the drug. "We hope we have made a major impact on the reduction of heroin addiction," said Sen. Carl Levin (D-MI), who helped sponsor the act, at a Wednesday press conference in Washington, DC. "Currently the available medications, methadone and ORLAAM (a relative of methadone), are extremely useful but ensnared in regulations that grossly limit their potential effectiveness," added Wayne State University psychiatry professor Charles Schuster. Of an estimated one million heroin habituated heroin users in the US, only 200,000 are currently seeking treatment, according to the National Institutes on Drug Abuse. Half of all persons offered methadone maintenance refuse, citing onerous restrictions, dingy facilities, dangerous neighborhoods and a lack of say in their own treatment. The FDA approved two buphrenorphine formulations, drugs marketed under the names Subutex and Suboxone by British drug-maker Reckitt Benckiser Pharmaceuticals. Subutex is buphrenorphine alone, while Suboxone also includes naloxone, another drug that blocks the effects of opioids on the brain. "Until recently, opiate dependence treatments... like methadone could be dispensed in a very limited number of clinics that specialize in addiction treatment," the FDA noted in a Wednesday press release. "As a consequence, there have not been enough addiction treatment centers to accommodate all patients desiring therapy." Sen. Orrin Hatch (R-UT), another sponsor of the 2000 legislation, also attended the Wednesday press conference. He reiterated his opposition to legalizing drug use while arguing that drug abusers should be treated as patients, not criminals. "I hope that FDA approval will help spur the private sector to redouble its efforts to find new cures for drug addiction," said the veteran drug warrior, whose bill to remedy disparities between crack and powder cocaine sentences would do so by increasing powder penalties and slightly decreasing crack penalties. According to the US Sentencing Commission, his bill, if passed, would have freed a grand total of 67 prisoners during the last three years.
|
