FDA advisory committee recommends Probuphine to treat opioid dependence- Titan Pharmaceuticals

The Psychopharmacologic Drugs Advisory Committee (PDAC) of the FDA voted 12 to 5 in favour of approving Probuphine, from Titan Pharmaceuticals, the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction, in stable patients receiving 8 mg or less per day of buprenorphine. 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 27 February 2016.

Comment: Probuphine is an investigational subdermal implant designed to deliver buprenorphine continuously for six months following a single treatment, and to promote patient compliance and retention. Buprenorphine, which is the active ingredient in multiple FDA-approved drug products for the treatment of opioid addiction, is currently available in tablet and film formulations that require self-administration by patients on a daily basis.