Relistor Can Be Approved For Chronic Pain Patients With Constipation, FDA Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Agency grants Salix/Progenics’ appeal seeking a chronic use indication for the mu opioid receptor antagonist without the need for additional clinical data on cardiovascular safety pre-approval. Decision also bodes well for AstraZeneca’s Movantik, which has a September user fee deadline.