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 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 can be approved on the data submitted in the sNDA. 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 has directed Salix to work with and submit certain information to the Division of Gastroenterology and Inborn Errors Products (DGIEP). Salix intends to submit the requested information over the next several weeks. The requested information includes: proposed product labeling and a proposal(s) for one or more post-marketing observational cohort studies designed to assess the relative incidence of Major Adverse Cardiovascular Events (MACE) among chronic non-cancer pain patients initiating RELISTOR via subcutaneous injection for OIC versus a comparator cohort.
This request for a proposal for a post-marketing observational study is in accordance with recommendations of the June 11-12, 2014 meeting of the Anesthetic and Analgesic Drug Product Advisory Committee. Salix will work with the DGIEP in an effort to provide information to the Division that will enable the Division to approve RELISTOR for use by patients with chronic non-cancer pain and experiencing OIC.
“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. We intend to submit the requested information to the FDA in the next several weeks. We look forward to working with the GI Division to gain marketing approval for this important therapy that works precisely to address the underlying cause of OIC.”