SOUTH SAN FRANCISCO, CA--(Marketwired - Apr 22, 2013) - Titan Pharmaceuticals, Inc. (
American Society of Addiction Medicine (ASAM) 44th Annual Medical-Scientific Conference, April 25-28, 2013, Chicago
Walter Ling, M.D., Professor of Psychiatry, Director, Integrated Substance Abuse Programs at the David Geffen School of Medicine at UCLA, will present results of the Probuphine Phase 3 development program on Friday, April 26, 2013 at a symposium sponsored by the National Institute on Drug Abuse (NIDA): "Buprenorphine: New Formulations, Medication Combinations, Indications and Longitudinal Effects." This two-part symposium will be held at 10:30 a.m. and 2:30 p.m. CT.
American Psychiatric Association (APA) 166th Annual Meeting, May 18-22, 2013, San Francisco
Katherine Glassman-Beebe, Ph.D., Executive Vice President and Chief Development Officer of Titan, will present "Buprenorphine Implants for the Maintenance Treatment of Opioid Dependence," on Monday, May 20 at 2 p.m. PT during NIDA Symposia 74: "Advances in Pharmacotherapies for Substance Use Disorders."
Titan submitted a New Drug Application (NDA) for Probuphine on October 29, 2012 under Section 505(b)(2) of the Food, Drug and Cosmetic Act, referencing the approved sublingual tablet formulations of buprenorphine. The Probuphine NDA was granted priority review designation with a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2013. In March 2013, Titan participated in a meeting with the Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) and announced that the majority of committee members voted for approval of Probuphine. Titan has entered into an agreement with Braeburn Pharmaceuticals that grants exclusive commercialization rights for Probuphine in the United States and Canada.
Probuphine is an investigational subdermal implant designed to deliver continuous and persistent, around the clock blood levels of buprenorphine for six months following a single treatment, and to simplify patient compliance and retention. Buprenorphine, an approved agent for the treatment of opioid dependence, is currently available in the form of daily dosed sublingual tablets and film formulations, with reported 2011 sales of $1.3 billion in the United States.
Probuphine was developed using ProNeura™, Titan's continuous drug delivery system that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate (EVA) and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper arm in a simple office procedure, and removed in a similar manner at the end of the treatment period. The drug substance is released slowly and continuously through the process of dissolution resulting in a steady rate of release.
The efficacy and safety of Probuphine has been studied in several clinical trials, including a 163-patient, placebo-controlled study over a 24-week period (published in the Journal of the American Medical Association (JAMA)), and a confirmatory study of 287 patients designed to evaluate efficacy versus placebo, and non-inferiority with a currently marketed sublingual formulation of buprenorphine. Results of the confirmatory study were announced in July 2011.
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The press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the regulatory approval process, the development, testing, production and marketing of our drug candidates, patent and intellectual property matters and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
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Titan Pharmaceuticals, Inc.