'Confused' panel declares CVOTs unnecessary for OIC drugs
This article was originally published in Scrip
Executive Summary
Chaos ruled the day at an FDA advisory committee meeting on 12 June, with some of the outside experts declaring they were confused by the agency's questions, leading to the panel reversing course – an action that in the end was a win for Salix's and Progenics' Relistor (methylnaltrexone), AstraZeneca's and Nektar's Movantik (naloxegol), Theravance's TD1211 and Develco's naloxone.