Ms. Doralie Segal

An article by Doralie Segal, who works in the Medications Development Division of the National Institute on Drug Abuse, entitled "Buprenorphine: What Interests the National Institute on Drug Abuse?", provided information about Buprenorphine."NIDA is a very strong advocate of combining treatment modalities.Pharmacological treatment addresses only one of the problems associated with drug dependence and when it is employed alone, relapse rates are very high.In fact, NIDA mandates that its clinical trials of new potential medications combine behavioral and psychosocial treatment and rehabilitative interventions in the research design."

NIDA released a new publication "Principles of Drug Addiction Treatment - A Research Based Guide", which underscores Ms. Segal's perspective.

An article by Doralie Segal, who works in the Medications Development Division of the National Institute on Drug Abuse, entitled "Buprenorphine: What Interests the National Institute on Drug Abuse?", provided information about Buprenorphine."NIDA is a very strong advocate of combining treatment modalities.Pharmacological treatment addresses only one of the problems associated with drug dependence and when it is employed alone, relapse rates are very high.In fact, NIDA mandates that its clinical trials of new potential medications combine behavioral and psychosocial treatment and rehabilitative interventions in the research design."

NIDA released a new publication "Principles of Drug Addiction Treatment – A Research Based Guide", which underscores Ms. Segal's perspective.Our Association supports such principles of drug addiction treatment and our policies have indicated that if doctors are to be involved in treating chronic opiate dependence and decide to use medications such as Buprenorphine in treating this disease, then such psychosocial or behavioral services should be provided at the medical practice setting or through referral.

"It's looking very good," says Doralie Segal of NIDA's Medications Development Division, who directs the buprenorphine project.
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While complete analyses of the specific findings from the clinical trial are not yet available, buprenorphine significantly reduced patients' craving for heroin, says Segal.Patients rated their levels of heroin craving during each week of the study by marking a visual scale, the ends of which represented minimum and maximum craving."Regardless of the dose, heroin craving dropped dramatically within 4 weeks and remained very low for the remaining 12 weeks of the study," Segal says.
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"Respiratory depression caused by buprenorphine is not of clinical concern," says Segal, "which makes it an extremely attractive treatment alternative."
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"It's certainly not our intent to supplant methadone," Segal says."Rather, NIDA wants to expand the drug treatment armamentarium and the overall number of patients in treatment."

The findings of the recently completed clinical trial soon will be submitted to the FDA for review, Segal says.However, NIDA will not submit a formal new drug application (NDA) to the FDA until late 1995 or early 1996, she says.An NDA initiates the FDA review process for all new medications.An NDA also is required by the FDA to begin the process for approving existing medications, such as buprenorphine, for uses other than those for which they were originally approved.

Segal says that NIDA will seek approval for a buprenorphine-naloxone combination tablet rather than for buprenorphine alone.The combination product is being developed by NIDA and Reckitt and Colman Pharmaceuticals, Inc., buprenorphine's manufacturer.

As a partial mu agonist, buprenorphine has some potential for misuse, making it subject to diversion--being sold by patients to other addicts.This characteristic makes it unsuitable to use as a take-home medication.Segal says the combination product is designed to address this problem.If a heroin addict attempted to abuse the combination tablet by dissolving it and injecting it intravenously, he or she would experience unpleasant withdrawal symptoms brought on by the naloxone component.However, naloxone, an opiate antagonist, does not produce these unpleasant effects when taken sublingually, beneath the tongue, in tablet form."We would like to market a product that could benefit various segments of the untreated opiate-dependent population," says Segal.

Gaining FDA approval of a buprenorphine-naloxone combination product, says Segal, will require submission of additional clinical data for the combination product.This will push the date for NDA submission to late 1995 at the earliest.Officials at NIDA, Reckitt and Colman, and the FDA currently are discussing the kinds of studies that will be necessary to include in the NDA, she says.However, once an NDA is filed, a quick decision from the FDA is expected, notes Segal.

The FDA has agreed to an expedited review of the buprenorphine compound.After an expedited review in 1993, the FDA approved LAAM, the newest medication available for treating opiate addiction, only 18 days after the NDA was submitted.A similar turnaround time would be likely with buprenorphine, says Segal.