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Relistor Expansion Plans In Question Following “Complete Response” Letter

This article was originally published in The Pink Sheet Daily

Executive Summary

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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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.

Cardiovascular Outcomes Trials For Opioid Agonists To Get FDA Panel Review

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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