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.

�While opioids are often used to treat patients with chronic, non-cancer pain, opioid-induced constipation can complicate their use,� said lead author of the study, E. Richard Blonsky, M.D., Director of The Pain and Rehabilitation Clinic of Chicago and Clinical Professor of Neurology at Northwestern University�s Feinberg School of Medicine. �The results from this double-blind study indicate that subcutaneous RELISTOR may be a promising treatment option for this patient population.�

Study design and results: Co-primary end points achieved

The phase 3 clinical trial examined the use of RELISTOR subcutaneous injection as a treatment for OIC (less than three bowel movements per week) in chronic, non-cancer pain patients, including those with back pain, osteoarthritis, or fibromyalgia. Four-hundred-sixty-nine patients were randomized to treatment, and of these, 460 patients received RELISTOR or placebo, dosed daily (QD) or every other day (QOD) for four weeks. Patients were required to stop all laxative use prior to entering the clinical study. Only the use of rescue laxatives was permitted during the study.

The pivotal phase 3 study�s co-primary end points both met statistical significance:

  • Patients taking RELISTOR experienced rescue-free bowel movements (RFBMs, or laxations) within four hours of the first dose significantly more frequently than those taking placebo (34.2% versus 9.9%, P
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