SOUTH SAN FRANCISCO, CA -- (Marketwire) -- 03/21/13 -- Titan Pharmaceuticals, Inc. (OTCBB: TTNP) today announced that the majority of Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) members recognized the favorable benefit-risk profile of Probuphine® and voted for approval (10 positive votes, 4 negative votes and 1 abstention). Probuphine® is a long-acting, subdermal implant formulation of buprenorphine for the maintenance treatment of adult patients with opioid dependence. 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 December 2012, Titan announced an exclusive license agreement with Braeburn Pharmaceuticals to the commercialization rights for Probuphine in the United States and Canada.
"We are pleased the Committee recognized the favorable benefit-risk profile of Probuphine and voted in strong favor of its approval," said Kate Glassman-Beebe, Ph.D., executive vice president and chief development officer of Titan. "We look forward to working with the FDA to complete its review of Probuphine and remain committed to addressing the growing unmet needs in managing patients with opioid dependence."
The committee also voted in favor of the effectiveness (10 positive votes to 5 negative votes) and safety (12 positive votes to 2 negative votes, with 1 abstention) of Probuphine. The largest portion of committee members abstained (6 abstentions, 5 positive votes and 4 negative votes) on the vote pertaining to the Risk Evaluation and Mitigation Strategy (REMS) program, as the program is still in discussion with the FDA.
The FDA is not bound by the recommendation of its advisory committee, but will consider the committee's guidance as it evaluates the Probuphine NDA.
Titan Conference Call and Webcast
Members of the Titan management team will host a conference call to discuss this update on March 22 at 9:00 a.m. ET. Participating on the call will be Sunil Bhonsle, president, Marc Rubin, M.D., executive chairman and Katherine Glassman-Beebe, Ph.D., executive vice president and chief development officer. The live webcast of the call may be accessed by visiting the Titan website at www.titanpharm.com. The call can also be accessed by dialing 888-737-3703, Participant Code: 9448389 five minutes prior to the start time. A replay of the call will be available on the Titan website approximately two hours after completion of the call and will be archived for two weeks.
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