On March 3, 2014, Titan Pharmaceuticals (NASDAQ:TTNP) and commercialization partner, privately-held Braeburn Pharmaceuticals Sprl, announced they had agreed in principle with the U.S FDA on a path forward for Probuphine, an investigational subdermal implant for the maintenance treatment of opioid dependence. The news comes a few months after Titan and Braeburn attended a face-to-face meeting with the agency in November 2013. The goals of that meeting were to review and discuss existing data, and to better understand the issues of the April 2013 complete response letter. The pathway forward agreed to with the FDA centers around testing Probuphine in experienced sublingual buprenorphine patients that are "stable" on 8mg of drug daily. This is in contrast to the...
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