FDA Committee Recommends Approval of Opioid Implant

A U.S. Food and Drug Administration committee has voted to recommend approval of Probuphine, described as the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction. The FDA’s Psychopharmacologic Drugs Advisory Committee voted 12-5 in favor of approving Probuphine for stable patients receiving 8 milligrams or less per day of buprenorphine. The implant was developed by Titan Pharmaceuticals Inc. in partnership with Braeburn Pharmaceuticals. Buprenorphine is a semi-synthetic opioid used in medication-assisted treatment to help p...