A phase 3 study of a methylnaltrexone bromide subcutaneous injection for OIC completed.
Progenics Pharmaceuticals, Inc. completed the treatment phase of a 1,034-patient, one-year, open-label, international, phase 3 safety study of methylnaltrexone bromide subcutaneous injection.
The study was performed on chronic, non-malignant pain patients with opioid-induced constipation (OIC). The patients received opioid pain medications for conditions such as osteoarthritis, back pain, and neuropathic pain. Progenics is scheduled to include results from the study in a supplemental New Drug Application to be submitted to 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, MD, PhD, Progenics' chief executive officer, chief science officer, and Founder, in a press release.
The trial is titled, “One-year Safety Study of Methylnaltrexone in Chronic, Non-Malignant Pain Patients.”
The study treated 1,034 patients with chronic, non-malignant pain. The patients were initially screened over a two-week period for constipation resulting from treatment with various opioid regimens. Dosing was a minimum of one dose per week up to a maximum of one dose daily using pre-filled syringes. The patients were evaluated for a 48-week treatment period, which was followed by a two-week follow-up period.
The goal of the study was to evaluate the long-term safety and tolerability of methylnaltrexone in chronic, non-malignant pain patients with OIC.
The results from this study as well as those of a 460-patient, double-blind, randomized, international phase 3 efficacy study in chronic, non-malignant pain patients with opioid-induced constipation are expected to be included in the sNDA submission in the first half of 2011.
RELISTOR is indicated for the treatment of opioid-induced constipation in patients with advanced illness receiving palliative care. It is to be given when response to laxative therapy has not been sufficient. RELISTOR is now approved in over 50 countries, including the U.S., E.U., Canada, Australia and Brazil.
Progenics Pharmaceuticals, Inc., of Tarrytown, NY, is a biopharmaceutical company that focuses on the development and commercialization of therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases. Principal programs are directed toward supportive care, oncology and virology.
Most recently, Progenics Pharmaceuticals announced its preclinical findings for its humanized monoclonal antibodies against the disease-causing toxins produced by the bacterium Clostridium difficile (C. difficile). The study was performed on hamsters with C. difficile-associated disease treated with the antibodies and resulted in 95% survival versus 0% survival for standard antibiotic treatment.