Home » Relistor CRL May Trigger More Safety Concerns With Constipation Drugs
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
Clinical Trials Advisor
Upcoming Events
-
04Apr
-
11Apr
-
14Apr
-
25Apr
-
14May