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Progenics and Wyeth Announce Positive Results from Three-Month,Clinical-Extension Study of Subcutaneous Methylnaltrexone for the,Treatment of Opioid-Induced Constipation in Patients with Advanced,Illness

M.D., Ph.D., Progenics' Founder, Chief Executive Officer and Chief Science Officer. "These data were included in the most recent submissions to the U.S. Food and Drug Administration and the European Medicines Agency. Progenics, and our collaborator, Wyeth, are encouraged by the positive effect of subcutaneous methylnaltrexone observed in our clinical trials."

Methylnaltrexone is a peripherally acting mu-opioid receptor antagonist that is designed to treat OIC without interfering with pain relief. Currently, there is no approved medication that specifically targets the underlying cause of OIC to relieve constipation in this patient population. In March 2007, Progenics submitted a New Drug Application (NDA) for subcutaneous methylnaltrexone to the United States Food and Drug Administration (FDA), followed in May 2007 by the submission of a marketing authorization application (MAA) in Europe to the European Medicines Agency (EMEA). Both regulatory submissions included the three-month open-label extension study data reported today. The NDA and MAA have been accepted and validated for review by the FDA and EMEA, respectively. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of January 30, 2008 to complete its review of the NDA, and completion of the MAA review is expected to occur in 2008.

About Opioid-Induced Constipation

Opioids provide pain relief by interacting with specific opioid receptors located in the central nervous system (CNS) - the brain and spinal cord. However, opioids also interact with the receptors outside the CNS, such as those affecting the gastrointestinal (GI) tract, altering intestinal motility and resulting in constipation that can be debilitating. Patients suffering from OIC may experience dry, hard stools, straining during evacuation, and incomplete and infrequent evacuation. Other symptoms of OIC can include nausea, vomiting and abdominal discomfort or pain. If left untreated or unresolved, OIC can lead to feca
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