FDA accepts application for opioid-induced constipation drug
TARRYTOWN, N.Y. — The Food and Drug Administration has accepted a regulatory approval application from Progenics Pharmaceuticals and Salix Pharmaceuticals seeking an additional approval for a pain drug.
The two drug makers announced Tuesday that the FDA had accepted their supplemental new drug application for Relistor (methylnaltrexone bromide), an injectable drug for treating opioid-induced constipation.
The drug originally was approved for treating patients taking opioids for cancer pain, but the companies are seeking approval for OIC in patients with pain not related to cancer. The FDA plans to make a decision on the drug by April 27, 2012.