Progenics Pharmaceuticals, Inc. (PGNX) Release: Phase 3 Clinical Study of RELISTOR Presented at American Pain Society Meeting Showed Positive Activity for the Treatment of Opioid-Induced Constipation in Chronic, Non-Cancer Pain Patients
5/7/2009 9:26:38 AM
COLLEGEVILLE, Pa. & TARRYTOWN, N.Y.--(BUSINESS WIRE)--Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced results from the one-month, double-blind portion of a phase 3 trial of RELISTOR® (methylnaltrexone bromide) subcutaneous injection that are scheduled to be presented tomorrow at the annual meeting of the American Pain Society in San Diego. The data presented from this 460-patient clinical study which evaluated RELISTOR for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain showed that significantly more patients treated with RELISTOR had laxation within four hours after the first dose compared with placebo. Results from this pivotal study would be included in a planned supplemental New Drug Application to the U.S. Food and Drug Administration. If approved for OIC in the chronic pain setting, this would add a new indication for RELISTOR in the United States. The positive outcome of this one-month, blinded portion of the study was previously announced (See original release at: www.progenics.com/releasedetail.cfm?ReleaseID=350881). A copy of the poster presentation with more information on this portion of the data is available at www.progenics.com. In addition, data from the two-month, open-label phase of this study will be presented at a future scientific meeting. Currently, RELISTOR is approved for the treatment of OIC in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.