NDA Accepted for Oral Formulation of Relistor
Valeant and Progenics Pharmaceuticals announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Relistor (methylnaltrexone bromide) tablets for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.
Relistor SC Injection is FDA-approved for the treatment of OIC in patients with advanced illness who are receiving palliative care and in 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 GI tract.
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