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TITAN PHARMACEUTICALS PROVIDES UPDATE ON CONFIRMATORY PHASE 3 STUDY OF PROBUPHINE
SOUTH SAN FRANCISCO, CA June 17, 2011 – Titan Pharmaceuticals, Inc. (OTC Bulletin Board:TTNP.OB) today announced the receipt of a letter from the U.S. Food and Drug Administration (FDA) on June 16, 2011, providing comments on the revised Statistical Analysis Plan (SAP) for the confirmatory Phase 3 study of Probuphine™ for patients with opioid dependence. Although the data review at all clinical sites is complete and the blinded data set is ready for analysis, Titan will need to delay the analysis of the data briefly to allow time for a discussion with the FDA and subsequent modification of the SAP as necessary.
“We are very pleased with the progress made by the clinical team and the clinical sites in completing the data review at the beginning of June, and preparing the blinded database for further analysis,” said Sunil Bhonsle, president of Titan Pharmaceuticals. “We will continue working closely with the FDA to finalize the statistical analysis plan and complete the analyses expeditiously, although it is unlikely that all this can be completed by the end of June as previously expected. We will provide an update on a revised timeline for reporting results of the study once we have spoken with the Agency in the next few days.”
The Phase 3 clinical trial is a randomized, placebo and active controlled, multi-center study conducted at 20 sites in the U.S. treating approximately 285 patients, aged 18 to 55 years across three dosing arms: Probuphine, Titan’s innovative, subcutaneous implant formulation that delivers a steady dose of the marketed drug buprenorphine over six months following a single treatment; SUBOXONE®, the approved and widely-used sublingual formulation of buprenorphine; and placebo. Patients in the trial were treated for 24 weeks and the Probuphine and placebo dosing arms were double-blinded, while the SUBOXONE arm was open-label. Titan’s first placebo controlled Phase 3 clinical trial of Probuphine was completed in 2008 with positive findings published in the Journal of the American Medical Association (JAMA) in October 2010.
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