Chronic Pain — 01 May 2013

Titan ImplantBy Pat Anson, Editor

Titan Pharmaceuticals, Inc. (OTCC: TTNP) has announced that it received a letter from the Food and Drug Administration delaying approval for an implantable version of buprenorphine, an opioid addiction treatment drug more widely known as Suboxone.

Titan said the FDA cannot approve the application in its present form for the Probuphine implant and asked for additional information on its effectiveness.

“Titan and our partner, Braeburn Pharmaceuticals, are extremely surprised and disappointed with the FDA’s response,” said Marc Rubin, MD, executive chairman of Titan Pharmaceuticals.

“Given the nationally-recognized, growing and devastating opioid dependence epidemic, there is critical need for new safe and effective treatments that reduce the likelihood of abuse, diversion and accidental pediatric exposure, and Titan and Braeburn remain committed to making Probuphine available for patients that need it.”

Read more at National Pain Report.


About Author

Pat Anson, Editor

Pat is Editor in Chief of American News Report. He is a veteran journalist and a former correspondent and producer for HealthWeek (PBS), Nightly Business Report (PBS) and other nationally syndicated shows. Pat has won numerous journalism awards, including a Golden Mike award for investigative reporting.

(1) Reader Comment

  1. “Surprised and disappointed” that the FDA doesn’t want to rush yet another opioid to the market? One of which, to date, reports on effectivness has not yielded the results originally hoped for. Not to mention the fact that the drug contains a very high level of bupe, cannot be titrated, cannot be easily discontinued due to adverse effects, is ridiculously expensive and so far has no plans or tested methodology for cessation. Considering the highly addictive nature of bupe, the extreme half-life of the chemical and lack of apparent protocol for medical montitoring of new patients, I think the FDA has finally made a wise decision after years of opiate tsunamis.