FDA Delays PDUFA Date for Titan’s Opioid Addiction Treatment

The FDA has extended the PDUFA date on Titan Pharmaceuticals’ Probuphine NDA for maintenance treatment of opioid addiction.

The new action date for the subdermal buprenorphine implant was moved from Feb. 27 to May 27.

Following a Psychopharmacologic Advisory Committee meeting in January, the FDA requested additional changes to the Risk Evaluation and Mitigation Strategy portion of the NDA, which the agency said qualified as a major amendment to the NDA. The advisory committee recommended approval of the opioid dependence implant.