FDAnews
www.fdanews.com/articles/81302-progenics-achieves-enrollment-target-in-trial-of-methylnaltrexone

PROGENICS ACHIEVES ENROLLMENT TARGET IN TRIAL OF METHYLNALTREXONE

September 30, 2005

Progenics Pharmaceuticals has reached the target enrollment of patients in the second pivotal Phase III clinical trial of its investigational drug methylnaltrexone (MNTX) for the treatment of opioid-induced constipation in patients with advanced medical illness.

This study is being conducted in 33 nursing homes and hospices across North America. Patients are randomized in the two-week study to receive either placebo or MNTX by subcutaneous injection every other day. The primary efficacy endpoint is relief of constipation within four hours after receiving the medication. The trial includes a three-month open-label extension period during which patients are eligible to receive MNTX.