Wyeth, Progenics To Test New Formulation of Oral Drug

Wyeth Pharmaceuticals and Progenics Pharmaceuticals will begin clinical testing of a new formulation of oral methylnaltrexone for the treatment of opioid-induced constipation. Preliminary results from the Phase II trial, conducted by Wyeth, showed that the initial formulation of oral methylnaltrexone was generally well tolerated but did not show sufficient clinical activity to advance into Phase III testing. If the new formulation is successful, the companies plan to file an NDA for oral methylnaltrexone in late 2009 or early 2010.

“Both the subcutaneous and intravenous formulations of methylnaltrexone have shown a high degree of activity in clinical trials. Therefore, the companies believe that the findings from the oral trial appear to be due to the orally administered formulation tested rather than the methylnaltrexone compound itself,” says Robert R. Ruffolo, Jr., Ph.D., senior vice president, Wyeth, and president, Wyeth Research. “We remain strongly committed to the methylnaltrexone program and intend to file an NDA later this month for the subcutaneous dose form.”