CV “Think Tank” Consensus Should Guide Safety Trials, Firms Tell FDA
Opioid-induced constipation drugs are best handled by the alternative approaches to cardiovascular safety data collection favored by public/private group of experts, sponsors argue.
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FDA plans a public hearing Aug. 11 on confidentiality of interim results in cardiovascular outcomes safety trials, an issue that apparently has led to regulatory delays for Orexigen’s obesity treatment Contrave and Sanofi’s antidiabetic agent lixisenatide.
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.
AstraZeneca’s peripherally acting mu-opioid receptor antagonist was not associated with an increased incidence of major cardiovascular events in Phase III studies of chronic pain patients with opioid-induced constipation. An FDA advisory committee will review CV safety data for the drug class June 11-12.