Wyeth, Progenics Begin Three Trials With Methylnaltrexone

Wyeth Pharmaceuticals and Progenics Pharmaceuticals announced the start of three new clinical studies for their investigational drug, methylnaltrexone, a peripherally acting mu-opioid receptor antagonist for the treatment of opioid-induced constipation and postoperative ileus.

Two of the studies will evaluate subcutaneous methylnaltrexone for opioid-induced constipation. The first will be a Phase III clinical study conducted by Wyeth in patients with chronic pain not related to cancer.

This trial will enroll approximately 470 patients, and Wyeth said it expects to complete the trial by late 2008.

The second subcutaneous methylnaltrexone trial is a Phase II study to be conducted by Progenics in patients rehabilitating from an orthopedic surgical procedure who use opioids to control postoperative pain. The trial will enroll approximately 260 patients in the U.S., and Progenics said it anticipates completing the trial by mid-2008.

The third trial is a Phase III intravenous methylnaltrexone study being conducted by Wyeth in patients with postoperative ileus following a ventral hernia repair via laparotomy or laparoscopy. The trial will enroll approximately 500 patients, and the company said it expects to finish the trial by mid-2008.

Methylnaltrexone is under review by the FDA, the European Medicines Agency and the Australian Therapeutic Goods Administration in its subcutaneous form for the treatment of opioid-induced constipation.