FDA has accepted for NDA review Relistor (methylnaltrexone bromide) for Tablets to treat opioid-induced constipation (OIC) with chronic non-cancer pain- Valeant
Valeant Pharmaceuticals International, Inc. and Progenics Pharmaceuticals, Inc. announced that the FDA has accepted for review Valeant's New Drug Application for Relistor (methylnaltrexone bromide) Tablets for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of April 16, 2016. 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.
The new indication, if granted, for an oral/tablet version of Relistor will put it in a better position to compete with Movantik/Moventig (naloxegol) from AstraZeneca.
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