sNDA Accepted for Relistor for Opioid Induced Constipation in Non-Cancer Patients

Progenics Pharmaceuticals and Salix Pharmaceuticals announced that the FDA has accepted for filing a supplemental New Drug Application (sNDA) for Relistor (methylnaltrexone bromide) Subcutaneous Injection to treat opioid-induced constipation (OIC) in patients with non-cancer pain. Results from 31 studies involving more than 4,000 patients supporting the safety and efficacy of Relistor in a new indication were included in the sNDA. The FDA has issued an action date of April 27, 2012 under the Prescription Drug User Fee Act.

Relistor, a peripherally acting mu-opioid receptor antagonist, counteracts the constipating effects of opioid medications in the gastrointestinal tract without affecting their ability to relieve pain. Relistor Subcutaneous Injection has been already approved to treat OIC in patients with advanced illness who are receiving palliative care with insufficient response to laxative therapy.

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