Positive US FDA advisory panel view on PAMORAs

The majority of US Food and Drug Administration Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) members yesterday voted that the FDA should not require cardiovascular outcomes trials for the peripherally-acting mu-opioid receptor antagonist (PAMORA) class of drugs. Following a clarification of the vote, the majority of the Committee suggested continued post-approval data collection for cardiovascular safety.

The FDA convened a meeting of the AADPAC to review the class of peripherally acting opioid receptor antagonists on June 11-12, 2014. The meeting assessed the necessity, timing, design and size of cardiovascular outcomes trials to support approval of products in the class, for the proposed indication of opioid-induced constipation (OIC) in patients taking opioids for chronic non-cancer pain. The FDA is not bound by the Advisory Committee’s recommendation, but takes its advice into consideration when reviewing applications for investigational medicines.

Includes AstraZeneca’s Movantik