California’s Titan Pharmaceuticals Announces FDA Advisory Committee Recommends Approval of Probuphine for the Treatment of Adult Patients With Opioid Dependence

Circle Connections: New Products & Services Titan Pharmaceuticals, Inc. 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 . . .