FDA Approves Buphrenorphine for Home Addiction Treatment 10/11/02

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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.

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Issue #258, 10/11/02 Editorial: Just Claims | Ordeal of the Pain Doctors: California Physician Still Struggling to Clear His Name, Trial Date Set for December | DRCNet Interview: Nandor Tanczos, Member of Parliament, New Zealand | California Medical Marijuana Chronicles: A Widening Conflict | MedMj Chronicles I: The Feds Are Deadly Serious: Bryan Epis Sentenced to Federal Prison | MedMj Chronicles II: San Jose Police Department Cuts Ties with DEA Task Force | MedMj Chronicles III: Marijuana Patients and Caregivers Sue the Feds, Seek Order to Stop Raids | MedMj Chronicles IV: Marijuana Rescheduling Petition Revived | FDA Approves Buphrenorphine for Home Addiction Treatment | Whose Brain on Drugs? Stanford Symposium Focuses on Addiction and Chemistry | Newsbrief: Colombian Ombudsman Petitions Government for Suspension of Herbicide Spraying | Newsbrief: RAVE Act Stalled in House, Could Be Dead for the Year | Newsbrief: Wisconsin Couple Commit Suicide After Pot and 'Shroom Bust, Forfeiture Notice | Newsbrief: Ban on Narcocorridos Spreads in Mexico | Newsbrief: School Districts Drug Testing for Tobacco, Too | Newsbrief: Leaders of Former Soviet Republics Meet to Fight Drugs and Terror, Drink Wine | Newsbrief: Canadian Researchers Seek Approval for Heroin Maintenance Study | Calling on Students to Raise Your Voices for Repeal of the HEA Drug Provision | Action Alerts: Rave Bill, Medical Marijuana, Higher Education Act Drug Provision | The Reformer's Calendar

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