Relistor CRL May Trigger More Safety Concerns With Constipation Drugs

The FDA’s recent complete response letter (CRL) on Salix’s sNDA for opioid-induced constipation (OIC) drug Relistor most likely cites safety concerns and signals increased scrutiny for all makers of these drugs, analysts say. The agency may be cautious about a cardiovascular class-effect in mu-receptor antagonist candidates such as Relistor (methylnaltrexone bromide), Cantor Fitzgerald analyst Irina Rivkind writes.
Clinical Trials Advisor