Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Valeant Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for Relistor (methylnaltrexone bromide) tablets designed to treat opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.
Subscribe to our email newsletter
Progenics Pharmaceuticals has exclusively licensed development and commercialization rights for its first commercial product, Relistor, to Valeant.
Relistor is a peripherally acting mu-opioid receptor antagonist designed to block the constipating effects of opioid pain medications in the gastrointestinal tract.
The drug does not cross the blood-brain barrier and relieves the distressing effects of the constipation without affecting the analgesic effect of the opioid.
In the US, Relistor Subcutaneous Injection was approved in 2008 to treat OIC in patients with advanced illness who are receiving palliative care, and in 2014 the drug obtained approval to treat OIC in patients with chronic non-cancer pain.
The company said that Relistor Subcutaneous Injection is contraindicated in patients with known or suspected gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.