Transdermal Buprenorphine for Opiate Antagonist Therapy

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DESCRIPTION (provided by applicant): Opiate antagonist therapy is an important treatment for recently withdrawn opiate addicts. Buprenorphine is a mixed agonist-antagonist which eliminates physiological reinforcement by blocking subjective opiate reward. Recently marketed as sublingual tablets, buprenorphine is very effective and is preferred by subjects to methadone or naltrexone. BIOTEK proposes to improve buprenorphine therapy by developing a 3-day transdermal delivery system. Such a patch would provide steady maintenance of agonist therapy to foster compliance. If such a patch can be made to contain relatively little buprenorphine, the motivation for subversion and abuse will be minimal. In vitro results on human skin obtained during Phase I strongly support the feasibility of such a patch, and rabbit irritation studies suggest that it will be non-irritating. Phase II will establish patch specifications suitable for GMP manufacture, confirm the in vitro performance of the selected formulation, prepare and characterize GMP clinical samples, initiate stability studies, submit an IND, and conduct an initial human study of safety and pharmacokinetics.