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Valeant submits NDA for oral Relistor tablets for opioid-induced constipation

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Valeant Pharmaceuticals and Progenics Pharmaceuticals have announced the submission of a New Drug Application to the FDA for orally administered Relistor tablets for the treatment of adults with chronic non-cancer pain suffering from opioid-induced constipation, according to a press release.

Relistor (methylnaltrexone bromide), a peripherally acting mu-opioid receptor antagonist, prevents constipation caused by opioid pain medications without impacting the analgesic effect as it does not cross the blood-brain barrier, the release said.

Relistor subcutaneous injection was approved in 2008 for opioid-induced constipation in patients with advanced illness receiving palliative care, and in 2014 for the same indication in patients with chronic non-cancer pain.

Progenics has exclusively licensed development and commercialization rights for Relistor to Valeant, according to the release.