TTNP ($0.67) I would like to re-visit this one end of April or Beginning of May. …Agreement In Principle With FDA… "We expect to hear back publicly from Titan in the next month or two on things like patient enrollment numbers and the data analysis plan"
On March 3, 2014, Titan and Braeburn 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 8 mg of drug daily. This is in contrast to the original New Drug Application (NDA) that called for use of Probuphine in opioid addicts that are first starting out on therapy with buprenorphine.
The agreement includes the design of a clinical study in support of re-filing the NDA for Probuphine. Although final details of the required clinical study are yet to be finalized, Titan and Braeburn note they expect to conduct a randomized, double blind and double dummy design clinical study comparing four Probuphine implants to treatment with 8 mg or less of Suboxone, an approved daily dosed sublingual formulation of buprenorphine. The “double dummy” design incorporates an implant and oral tablet, with patient randomized to receive Probuphine plus a placebo tablet or Suboxone plus a placebo implant. The primary goal of the study is to provide information for a non-inferiority analysis of patient outcomes at six months. The FDA is currently reviewing the design protocol submitted by Braeburn. We expect to hear back publicly from Titan in the next month or two on things like patient enrollment numbers and the data analysis plan.
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