FDA advisory panel backs approval of Probuphine, first six-month implant to treat opioid addiction

The Psychopharmacologic Drugs Advisory Committee (PDAC) of the US Food and Drug Administration has voted 12 to five in favor of approving Probuphine, the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction, in stable patients receiving 8mg or less per day of buprenorphine.

The product has been developed by US firm Titan Pharmaceuticals (Nasdaq: TTNP), whose shares shot up 13.7% to $3.41 on the news in yesterday’s trading, in collaboration with Braeburn Pharmaceuticals.

The Committee's vote followed presentation and discussion of data regarding Probuphine's efficacy, safety, and risk-benefit profile. The New Drug Application (NDA) for Probuphine was resubmitted to the FDA in August 2015, and accepted by the FDA in September 2015. A target agency action date has been set for February 27, 2016. In 2013, the FDA rejected the original applications, despite an overall favorable review by an FDA advisory panel vote (The Pharma Letter May 1, 2013).