NDA Submitted for Oral Formulation of OIC Drug Relistor
Valeant Pharmaceuticals and Progenics Pharmaceuticals announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Oral Relistor (methylnaltrexone bromide) Tablets for the treatment of opioid-induced constipation (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. It 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 already been FDA approved to treat OIC in patients with advanced illness who are receiving palliative care, and for the treatment of OIC in patients with chronic non-cancer pain.
For more information call (877) 361-2719 or visit Valeant.com