FDA backs post-approval CV safety trials of Movantik for Opioid Constipation - AstraZeneca

The majority of FDA Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) members voted that the FDA should not require cardiovascular outcomes trials for the peripherally-acting mu-opioid receptor antagonist (PAMORA) class of drugs, which includes Movantik (naloxegol oxalate), from AstraZeneca, a treatment for Opioid-induced Constipation (OIC) for patients with chronic non-cancer pain. This follows concerns which emerged last year that the class of drugs may have negative cardiovascular impact.

Following a clarification of the vote, the majority of the Committee suggested continued post-approval data collection for cardiovascular safety. In addition to the US, AstraZeneca has also submitted regulatory filings for the drug with health agencies in the European Union and Canada.