Salix Pharmaceuticals, Ltd. (SLXP) and Progenics Pharmaceuticals (PGNX) announced that the FDA has informed Salix that the supplemental New Drug Application (sNDA) for RELISTOR (methylnaltrexone bromide) Subcutaneous Injection, 20 mg/ml, for the treatment of opioid-induced constipation in patients taking opioids for chronic non-cancer pain has been assigned a user fee goal date of September 29, 2014.
RELISTOR is a Peripherally Acting Mu Opioid Receptor Antagonist (PAMORA) specifically designed to block the constipating effects of opioids in the gastrointestinal tract. RELISTOR is under license to Salix Pharmaceuticals, Inc. from Progenics Pharmaceuticals, Inc.
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