Titan Pharmaceuticals of the USA has announced the early completion of enrollment in a Phase III clinical study of Probuphine (buprenorphine) in the treatment of opioid dependence. Enrollment was completed about one month ahead of schedule, with results from the study expected to be available by the third quarter of 2008.
This randomized, double-blind, placebo-controlled, multi-center Phase III trial will evaluate the safety and effectiveness of treatment with Probuphine in reducing opioid dependence over 24 weeks of treatment in approximately 150 patients. This study is part of a registration directed program intended to obtain marketing approval of Probuphine for the treatment of opioid dependence in the USA and Europe.
"Opioid dependence is a major health and social issue, and is a chronic medical condition that requires long-term treatment. Probuphine offers the potential to provide an additional, valuable therapy for this condition," stated Paul Casadonte, Associate Clinical Professor of Psychiatry New York University School of Medicine, USA.
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