Progenics files new OIC treatment with FDA

USA-based firms Progenics Pharmaceuticals and Wyeth Pharmaceuticals say that the former is in the process of submitting a New Drug Application to the Food and Drug Administration, seeking approval for a co-developed subcutaneous formulation of methylnaltrexone as a treatment for opioid-induced constipation. The companies explained that the drug was designed not to interfere with pain-relief in patients receiving opioid-based palliative care.

In December 2005, Progenics and Wyeth entered into an exclusive, worldwide joint agreement, focused on the development and commercilization of methylnaltrexone for opioid-induced treatment side effects (Marketletters passim). The drug is also being assessed as an intravenous therapy for the treatment of post-operative ileus.

The firms said that the NDA submission is based on data from two Phase III trials of the drug, in which its safety and efficacy were established. Progenics said that it expects the FDA to review the filing using its standard process, and added that, if the NDA is successful, it plans to launch a single-use version of the product in early 2008, with a pre-filled syringe version following later that year.