An FDA advisory committee has voted 12 to 5 to recommend approval of a buprenorphine implant (Probuphine) to treat patients who are already stable on low doses of the sublingual version of the drug.
The favorable vote followed a substantial re-analysis of clinical trial data by FDA reviewers, who raised concerns about missing data and the company’s definition of a responder.
Ultimately, those re-analyses quashed drugmaker Braeburn Pharmaceutical’s suggestions that Probuphine was superior to sublingual buprenorphine, showing in conservative estimates that the company could only prove non-inferiority.
Source: MedPage Today
Filed Under: Drug Discovery