Cardiovascular Outcomes Trials For Opioid Agonists To Get FDA Panel Review
This article was originally published in The Pink Sheet Daily
Salix and Progenics’ appeal of FDA’s “complete response” letter for Relistor argues that potential safety issues for the opioid-induced constipation claim could be handled in a post-marketing study.
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AstraZeneca’s mid-stage pipeline includes several interesting assets, particularly in oncology, and the company is determined to accelerate development of key projects under CEO Soriot’s turn-around plan. But even if the R&D team successfully executes on faster development timelines, the reward for investors is years away.
FDA requested more clinical data on Salix/Progenics’ sNDA for approval of the subcutaneous formulation of methylnaltrexone in chronic, non-cancer pain patients with opioid-induced constipation. The regulatory setback could have implications for the companies’ planned September filing of an oral formulation in the same patient population.
Senators ask the agency to address the “regulatory loophole” permitting telehealth companies to promote prescription drugs without disclosing side effects and question if FDA has enforcement authority over third-party social media influencer promotions.