Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Progenics Pharmaceuticals (NASDAQ:PGNX) today announced that the Food and Drug Administration (FDA or Agency) 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 (OIC) in patients taking opioids for chronic non-cancer pain has been assigned a user fee goal date of September 29, 2014.
On July 10, 2014 the FDA Office of Drug Evaluation III responded to the Company’s formal appeal filed in response to the Complete Response Letter (CRL) of July 27, 2012 to the supplemental NDA (sNDA) for RELISTOR. The Agency’s letter stated that, “Salix’s request that FDA approve the supplemental NDA for RELISTOR subcutaneous injection for the treatment of opioid-induced constipation in patients with chronic non-cancer pain based on the submitted data is granted.” In regard to the RELISTOR sNDA the Agency directed Salix to work with and submit certain information to the Division of Gastroenterology and Inborn Errors Products (DGIEP). On July 29, 2014 the FDA accepted Salix’s resubmission. On August 8, 2014 the FDA communicated to Salix that the Company’s resubmission is a complete, class 1 response to the FDA’s action letter and assigned the user fee goal date.
“The approval and availability of RELISTOR for this expanded use will be an important and welcomed advancement for treating the underlying cause of OIC experienced by many patients taking opioids for chronic non-cancer pain,” stated Bill Forbes, Executive Vice President, Medical, Research and Development and Chief Development Officer, Salix. “Frequently, opioid analgesics are prescribed to manage pain in patients suffering from chronic conditions. Unfortunately, the use of an opioid can result in debilitating constipation for a significant number of these patients. RELISTOR is a peripherally acting mu-opioid receptor antagonist (PAMORA) designed to counteract the constipating effects of opioid pain medications without affecting their ability to relieve pain.”