31 August 2015 - Titan Pharmaceuticals, Inc, a specialty pharmaceutical company developing proprietary therapeutics for the treatment of select chronic diseases utilising its ProNeura long-term drug delivery technology, today announced the resubmission by Braeburn Pharmaceuticals of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Probuphine, Titan’s subdermal implant containing buprenorphine hydrochloride for the maintenance treatment of opioid addiction. Probuphine is designed to deliver continuous, non-fluctuating levels of buprenorphine for six months following a single treatment.

"We are extremely pleased by the Braeburn and Titan teams' expeditious preparation of this NDA following the positive results of the final Phase 3 trial," said Kate Glassman Beebe, PhD, Titan's executive vice president and chief development officer. "We expect a six-month review cycle, and if approved, Probuphine would be the first marketed product to provide maintenance treatment of opioid addiction continuously for six months following a single procedure. Probuphine has the potential to increase patient compliance and decrease the risk of diversion, and could become an essential tool in the treatment of opioid addiction."

For more details, go to: http://www.titanpharm.com/press/2015/15-08-31-Titan-announces-resubmission-of-the-new-drug-application-for-probuphine.htm