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Progenics methylnaltrexone

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

NDA submission for Progenics' subcutaneous methylnaltrexone for treatment of opioid-induced constipation in patients with advanced medical illnesses could come "as early as the end of 2005." Progenics reported pivotal trial results March 7; the Phase III study yielded highly statistically significant results for all endpoints at both dose levels of subcutaneous MNTX (0.15 mg/kg & 0.30 mg/kg). "On average, laxation occurred within about one hour in the MNTX-treated patients," the company says. Progenics is developing intravenous and oral formulations of MNTX for use in post-operative bowel dysfunction and opioid-induced constipation, respectively. Methylnaltrexone is a derivative of the alcoholism treatment naltrexone...
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