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FDA Accepts New Drug Application for Oral Relistor Tablets for Opioid-induced Constipation
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The FDA has accepted for review the new drug application submitted for oral Relistor tablets for the treatment of opioid-induced constipation in adults with chronic noncancer pain, the manufacturer announced.
Relistor (methylnaltrexone bromide, Valeant Pharmaceuticals) is a peripherally acting mu-opioid receptor antagonist that prevents the constipating effects of opioid pain medications without affecting their analgesic effects.
According to a press release, Relistor subcutaneous injection was approved by the FDA in 2008 for opioid-induced constipation in patients with advanced illness receiving palliative care, and in 2014 for opioid-induced constipation in patients with chronic noncancer pain.
Relistor is Progenics Pharmaceuticals’ first commercial product, and the company exclusively licensed its development and commercialization rights to Valeant, the release said.
The FDA has assigned April 19, 2016, as the Prescription Drug User Fee Act (PDUFA) action date for Relistor oral tablets. Valeant and Progenics announced the NDA submission for oral Relistor on June 23.