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METHADONE DERIVATIVE LAAM’s NDA SUBMISSION EXPECTED FROM NIDA AND BIOMETRIC RESEARCH INSTITUTE BY MARCH; NDA WILL INCLUDE RESULTS OF "REAL WORLD" STUDY

Executive Summary

An NDA submission for the use of LAAM (levo-alpha- acetylmethadol) as a maintenance treatment for opiate dependence is expected from the National Institute on Drug Abuse and the Biometric Research Institute in March, NIDA Medications Development Division Director Charles Grudzinskas, PhD, said Dec. 10 at a meeting of FDA's Drug Abuse Advisory Committee. While NIDA is sponsoring the clinical development of LAAM, the NDA will officially be submitted by BRI. The firm plans to license the rights to LAAM to Arlington, Va.-based startup Biodevelopment Corp., NIDA said. FDA has agreed to give LAAM an expedited review ("The Pink Sheet" Aug. 17, T&G-9). Pilot Drug Evaluation Staff Director John Harter, MD, said at the meeting that FDA plans to bring LAAM back before the advisory committee within 30 days after the NDA submission. The Dec. 10-11 meeting was held to "give [FDA] some very concrete advice on where to go from here because we would like to move this product along as quickly as possible," Committee Chairman Theodore Cicero, PhD, Washington University, St. Louis, said. The meeting was meant to clear up outstanding issues with the LAAM database and labeling so that the April meeting can focus primarily on the results of an ongoing "labeling validation" study. The trial protocol, designed with input from FDA's Pilot Drug Evaluation Staff, is meant to evaluate LAAM's use in a "real world" setting, NIDA Medications Development Division Deputy Director Frank Vocci, PhD, said. The study, which has enrolled over 600 patients, began in June when NIDA distributed a draft package insert for LAAM to 26 drug abuse treatment centers in the U.S. The centers, which were "real drug treatment centers, not academic centers used to doing research," were instructed to enroll a wide range of typical addiction patients. Only "end-stage AIDS patients and addicts with pending incarceration" were excluded, Vocci said. The trial has a 12-week phase followed by a one year follow-up. FDA's Harter said "the protocol for the trial essentially was the package insert." Pilot Drug Medical Officer Curtis Wright, MD, said the trial should "give us a snapshot of what will happen when this drug is approved." The controls in the non-randomized trial are historical methadone use outcome data and concurrent "real time historic cohort" of methadone users, NIDA's Grudzinskas said. Wright told the advisory committee that LAAM is the first drug to be evaluated using this type of real world protocol, but indicated that such studies could be extended to other therapeutic categories. Grudzinskas called the trial design "the wave of the future" in drug evaluation. Harter described the development of the NDA package for LAAM as "a very interactive process between NIDA and FDA." Because the non-randomized trial is not blinded and patients enter and exit the 12-week protocol at different times, NIDA and FDA receive regular updates on the trial results. The results are placed in a rolling electronic database as they appear, building up what Harter called an "electronic IND/NDA." On Dec. 11, the advisory committee indicated its belief that even though older studies of LAAM are flawed compared by today's standards, the drug should be approved, pending the results of the labeling validation trial. Acting committee chair Richard Meisch, MD/PhD, University of Texas, said: "I think that the drug at this point is approvable." Harter commented: "We look for substantial evidence, and substantial evidence is made up of this series of studies which have to be judged against the time they were done." The committee agreed that FDA and NIDA should make a recommendation to the Drug Enforcement Agency that LAAM be rated a Schedule II controlled substance. The committee also suggested changes to the treatment regulations for LAAM to be published in an upcoming Federal Register. Harter responded: "I didn't hear anything that would make me think we should hold off on any of those things."

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