FDA Approves New Indication for OIC Drug Relistor

Salix Pharmaceuticals and Progenics Pharmaceuticals said they had received FDA clearance for a new indication on their opioid-induced constipation drug Relistor.

The agency cleared Relistor (methylnaltrexone bromide) subcutaneous Injection, 12 mg/0.6ml, for treating OIC in patients taking opioids for chronic pain not caused by cancer. The drug was approved in 2008 for treating OIC palliative care patients for whom laxatives don’t work.

The companies noted that roughly 27 million U.S. patients take opioids for chronic pain. Constipation is one of the most common side effects, with roughly 40% of these patients saying they experience OIC.

The approval of Relistor follows the FDA’s greenlight last month of AstraZeneca and Nektar’ OIC drug Movantik (naloxegol) for adults with chronic pain not caused by cancer. The drugmakers said they hoped to launch that drug in early 2015, but the date remains uncertain as the Drug Enforcement Administration considers a request to deschedule the product. — Neal Learner

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.