CV Trials For Symptomatic Conditions Feasible But Not Always Practical, FDA Panel Says

FDA committee members generally reject the notion that dedicated safety studies are not possible for peripherally active mu opioid receptor antagonists in chronic pain patients, but acknowledge a low background cardiovascular risk and symptomatic nature of opioid-induced constipation make such trials problematic. The advisors’ opinions on the practicality of such trials in low-risk patients with symptomatic conditions could have implications beyond PAMORAs.

Cardiovascular outcomes trials may be feasible, but not necessarily practical, in a highly symptomatic patient population with a low background rate of events, FDA’s Anesthetic and Analgesic Drug Products Advisory Committee concluded in a recent two-day meeting on peripherally active mu opioid receptor antagonists (PAMORAs).

Through their majority vote recommending against CV outcomes trials for all drugs in the PAMORA class, committee members made clear...

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