Valeant Pharma Announces Submission Of U.S. NDA For Oral RELISTOR - Quick Facts

(RTTNews) - Valeant Pharmaceuticals International, Inc. (VRX, VRX.TO) and Progenics Pharmaceuticals, Inc. (PGNX) announced that Valeant submitted a New Drug Application to the U.S. Food and Drug Administration for RELISTOR (methylnaltrexone bromide) Tablets for the treatment of opioid-induced constipation or OIC in adult patients with chronic non-cancer pain.

RELISTOR is a peripherally acting mu-opioid receptor antagonist specifically designed to block the constipating effects of opioid pain medications in the gastrointestinal tract. RELISTOR does not cross the blood-brain barrier, therefore relieving the distressing effects of the constipation without affecting the analgesic effect of the opioid. RELISTOR Subcutaneous Injection has been FDA approved since 2008 to treat OIC in patients with advanced illness who are receiving palliative care, and was approved in 2014 for the treatment of OIC in patients with chronic non-cancer pain.

Progenics has exclusively licensed development and commercialization rights for its first commercial product, RELISTOR, to Valeant Pharmaceuticals. RELISTOR (methylnaltrexone bromide) Subcutaneous Injection is a treatment for opioid-induced constipation approved in the United States for patients with advanced illness and chronic non-cancer pain.