The FDA approved two new opioids, with stated reservations from some members. A joint FDA advisory committee voted 14-to-3 to recommend approval of an abuse-deterrent formulation of extended-release hydrocodone (Vantrela) to treat severe pain, but also wished for better ways to evaluate abuse-deterrence. Meeting a second day, the same panel also voted 9-6 to “recommend” approval of a different abuse-deterrent product, this one combining extended release oxycodone with naltrexone (Troxyca). The slim margin is often seen a null recommendation.
Read more from MedPage Today here.