TTNP: Titan Pharma....INPLAY
FDA Makes New Opioid Addiction Treatment A Priority
The FDA has accepted the New Drug Application (NDA) for Titan Pharmaceuticals’ subdermal implant Probuphine®. The New Drug has been granted the distinction of Priority Review, a status given to regimens that can offer significant advances in the treatment process, whether by improving safety measures or offering treatment where there was no adequate version before. The FDA set a target date of April 30, 2013 for the review of Titan’s NDA.
Probuphine is the first subdermal implant that would provide long-acting doses of buprenorphine hydrochloride in the treatment of opioid addiction. Adult patients would receive an implant which would dispense a consistent dose of buprenorphine and hydrochloride over the course of six months.
Executive vise president and chief development officer at Titan, Katherine Beebe, Ph.D, stated in the company’s press release:
This is an important milestone for Probuphine and the Priority Review designation further underscores the critical need for new treatments for opioid dependence, With more than two million people addicted to opioids in the U.S. alone, there is a need for safe and effective treatments that also reduce the risk of abuse or accidental use. Probuphine has demonstrated clinically meaningful and statistically significant treatment benefits across several clinical trials and we look forward to supporting the NDA review process and, potentially, offering a new treatment option to patients and physicians.”
Results of a randomized trial comparing subdermal implant, oral and non-medicated treatments can be read, with subscription, at JAMA Psychiatry. Over the course of six months, three hundred and six opioid addicts attended biweekly counseling while undergoing one of three treatments:
1000-mg naltrexone implant and oral placebo
placebo implant and 50-mg oral naltrexone hydrochloride
placebo implant and oral placebo
At the end of the six months, 54 of 102 patients in the first group remained in treatment without relapse compared to 16 of 102 patients in the second group and 11 of 102 in the third group. These higher results are no doubt part of the reason for Probuphine receiving Priority Review from the FDA.
AI
