Titan Pharma's Probuphine gets positive backing from FDA advisory panel

The majority of Psychopharmacologic Drugs Advisory Committee (PDAC) of the US Food and Drug Administration (FDA) members recognized the favorable benefit-risk profile of US drugmaker Titan Pharmaceuticals’ (OTCBB: TTNP) Probuphine and voted for approval (10 positive votes, four negative votes and one 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 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 USA 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, executive vice president and chief development officer of Titan, adding: "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."