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Cardiovascular Outcomes Trials For Opioid Agonists To Get FDA Panel Review

This article was originally published in The Pink Sheet Daily

Executive Summary

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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Relistor Expansion Plans In Question Following “Complete Response” Letter

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.

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