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www.fdanews.com/articles/75621-progenics-reports-additional-positive-results-from-methylnaltrexone-trial

PROGENICS REPORTS ADDITIONAL POSITIVE RESULTS FROM METHYLNALTREXONE TRIAL

August 22, 2005

Progenics Pharmaceuticals announced additional positive data from a previously completed pivotal Phase III clinical trial of its investigational drug, methylnaltrexone (MNTX) for the treatment of opioid-induced constipation in patients with advanced medical illness.

Final data analysis of the MNTX 301 study showed significant improvements in measures of constipation distress, bowel movement difficulty and consistency, and global impressions of clinical change. There were no increases in pain scores or opioid withdrawal symptoms in any treatment group. At both doses of MNTX tested, all prospectively defined secondary endpoints exhibited statistically significant differences compared to placebo.