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Titan Pharmaceuticals announces agreement in principle with FDA for Probuphine

Titan Pharmaceuticals announced that the company and its partner, Braeburn Pharmaceuticals, have agreed in principle with the U.S. Food and Drug Administration on the design of a clinical study in support of the New Drug Application for Probuphine, the company's investigational subdermal implant for the maintenance treatment of opioid dependence. The proposed clinical study will be a randomized, double blind and double dummy design that will provide information for a non-inferiority comparison of a six-month treatment with a dose of four Probuphine implants to treatment with 8mg or less of an approved daily dosed sublingual formulation of buprenorphine. Details of the study, including size and the data analysis plan, will be established following the FDA's review of a complete study protocol, which Braeburn expects to submit within the next two weeks. Titan and Braeburn submitted a detailed clinical study synopsis to the FDA several weeks ago, following discussions with the FDA in November 2013 regarding the Complete Response Letter issued to the Probuphine NDA.