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news.Psychopharmacologic Drugs Advisory Committee (PDAC) of the US Food and Drug Administration (FDA) has recommended the approval of Titan Pharmaceuticals' probuphine.
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Probuphine is a long-acting, subdermal implant formulation of buprenorphine for the maintenance treatment of adult patients with opioid dependence.
Titan Pharmaceuticals executive vice president and chief development officer Kate Glassman-Beebe said, "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 FDA, which is not bound by the recommendation of its advisory committee, will consider the committee guidance as it evaluates the Probuphine new drug application (NDA).
On 29 October 2012, Titan submitted a NDA for Probuphine under Section 505(b)(2) of the Food, Drug and Cosmetic Act, referencing the approved sublingual tablet formulations of buprenorphine.