CV Outcomes Trials: FDA Actions, Announcements Paint Conflicted Picture
This article was originally published in The Pink Sheet Daily
Policy of continuing safety trials into the post-approval setting gets favorable description in FDA meeting announcement, but delay of Contrave application suggests Orexigen may need to launch a new trial.
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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.
Weight loss drug Contrave delayed by three months while sponsor and agency discuss how to handle data transparency for ongoing cardiovascular outcomes trial.
Contrave could be approved by FDA in 2014, making it the third obesity therapeutic to reach the market in the last two years. An interim analysis of the CV outcomes study LIGHT demonstrates a favorable risk-benefit profile, management said.