Titan Pharmaceuticals Begins Probuphine Confirmatory Phase 3 Study

Titan Pharma said that the Phase 3 study will be conducted at approximately 23 sites in the US and randomise approximately 250 patients into three arms: Probuphine (100 patients), Suboxone (100 patients) and placebo (50 patients). The Probuphine and placebo arms will be double blinded, while the Suboxone arm will be open-label.

The study is designed to confirm the safety and effectiveness of treatment with Probuphine versus placebo in reducing use of illicit opioids over the 24 week treatment period, and also to perform a non-inferiority comparison of Probuphine with Suboxone which is the widely used sublingual formulation of buprenorphine, an approved drug for the treatment of opioid addiction.

Titan Pharma is planning to complete the patient enrollment by the end of 2010 and will complete the study by early Q3 2011, with results being available soon thereafter. The study is part of a registration directed program intended to obtain marketing approval of Probuphine for the treatment of opioid addiction in the US and Europe.

The National Institutes of Health (NIH) has supported this confirmatory study by awarding the company a two year $7.6m Research and Research Infrastructure Grand Opportunities grant through the American Reinvestment and Recovery Act of 2009 (ARRA), with the first year award of approximately $5.6m now available to Titan. The grant covers a little over half the cost of the study and it will be administered by the National Institute on Drug Abuse (NIDA).

Katherine Beebe, senior vice president, clinical development and medical affairs at Titan Pharma, said: “We are very pleased by the progress being made towards completion of the Probuphine Phase 3 clinical development program with the initiation of this confirmatory safety and efficacy study, and by the tremendous support for Probuphine provided by our investigators and the National Institute on Drug Abuse.”