Progenics Submits NDA for Subcutaneous Methylnaltrexone

TARRYTOWN, New York—Progenics Pharmaceuticals, Inc., in collabortion with Wyeth Pharmaceuticals, has submitted a new drug application (NDA) to the FDA for the subcutaneous formulation of methylnaltrexone for the treatment of opioid-induced constipation (OIC) in patients receiving palliative care.

Methylnaltrexone is a peripherally acting opioid-receptor antagonist designed to treat OIC without interfering with brain-centered pain relief. The NDA is based on data from two phase III studies. All of the primary efficacy endpoints of the studies were positive and statistically significant, and the therapy was generally well tolerated, the companies said in a news release.