Titan Pharmaceuticals resubmits application for opioid treatment approval

Titan Pharmaceuticals Inc. on Monday announced the resubmission by Braeburn Pharmaceuticals of a New Drug Application to the U.S. Food and Drug Administration for Probuphine.

Probuphine is Titan's sub-dermal implant containing buprenorphine HCl 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," Kate Glassman Beebe, Titan's executive VP and chief development officer, said. "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."

There are approximately 2.2 million people with opioid addiction in the U.S. and approximately 20 percent of this population is addicted to illicit opioids, such as heroin, and the other 80 percent to prescription opioids, such as oxycodone, hydrocodone, methadone, hydromorphone and codeine.

Titan Pharmaceuticals Inc. is a specialty pharmaceutical company that develops proprietary therapeutics mainly for the treatment of serious medical disorders.