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Wyeth/Progenics’ Relistor: FDA Says Yes, EU Likes It, Too

This article was originally published in The Pink Sheet Daily

Executive Summary

Compound helps bowel function in dying patients on opioids.

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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.

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.

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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