Titan Pharmaceuticals, Inc. (TTNP) and partner Braeburn Pharmaceuticals Tuesday said the Psychopharmacologic Drugs Advisory Committee or PDAC of the U.S. Food and Drug Administration voted 12 to 5 in favor of approving Probuphine, 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 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.

The FDA is not obligated to follow the recommendations of its Advisory Committee, but will consider the Committee's guidance as it completes its review of the Probuphine NDA.

For comments and feedback contact: editorial@rttnews.com

Business News