Progenics completes methylnaltrexone bromide subcutaneous injection phase 3 study in patients with OIC

Sep 22 2010

Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced the completion of the treatment phase of a 1,034-patient, one-year, open-label, international, phase 3 safety study of methylnaltrexone bromide subcutaneous injection in chronic, non-malignant pain patients with opioid-induced constipation (OIC). Patients in the study were receiving opioid pain medications for conditions such as osteoarthritis, back pain and neuropathic pain. Progenics plans to include results from this study in a supplemental New Drug Application to be submitted to the U.S. Food and Drug Administration (FDA) in the first half of 2011.

"We expect to present an analysis of the full dataset of this safety study at a medical conference following the submission of a complete study report to FDA," said Paul J. Maddon, M.D., Ph.D., Progenics' Chief Executive Officer, Chief Science Officer, and Founder.

Progenics Pharmaceuticals, Inc.,