Progenics Pharmaceuticals, Inc. announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) requesting approval for the use of Relistor (methylnaltrexone bromide) subcutaneous injection for the treatment of Opioid-Induced Constipation (OIC) in patients with chronic, non-cancer pain.

Relistor is the first approved medication that specifically targets the underlying cause of OIC. It is currently approved and sold in the United States, European Union, Canada, Australia and other countries for the treatment of OIC in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.

“This regulatory submission is an important milestone for Progenics as we work with our development and commercialization partner, Salix Pharmaceuticals, to make Relistor available to a broader population of patients,” said Mark R Baker, chief executive officer of Progenics.

Relistor is indicated for the treatment of OIC in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of Relistor beyond four months has not been studied in the advanced illness population.

Relistor is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. If severe or persistent diarrhoea occurs during treatment, advise patients to discontinue therapy with Relistor and consult their physician. Use of Relistor has not been studied in patients with peritoneal catheters. Safety and efficacy of Relistor have not been established in paediatric patients.

Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (i.e., cancer, peptic ulcer, Ogilvie's syndrome). Perforations have involved varying regions of the GI tract (e.g., stomach, duodenum, and colon).

Use Relistor with caution in patients with known or suspected lesions of the GI tract. Advise patients to discontinue therapy with Relistor and promptly notify their physician if they develop severe, persistent, and/or worsening abdominal symptoms.

The most common adverse reactions reported with Relistor compared with placebo in clinical trials were abdominal pain (28.5% vs. 9.8%), flatulence (13.3% vs. 5.7%), nausea (11.5% vs. 4.9%), dizziness (7.3% vs. 2.4%), diarrhoea (5.5% vs. 2.4%), and hyperhidrosis (6.7% vs. 6.5%).

Progenics Pharmaceuticals Inc., is a biopharmaceutical company with programs in gastroenterology, oncology and virology focused on innovative therapeutics for patients with debilitating conditions and life-threatening diseases.