Wyeth, Progenics to test subcutaneous methylnalatrexone

By Elaine Rigoli

Tampa, Fla., June 6 - Wyeth Pharmaceuticals and Progenics Pharmaceuticals, Inc. said two phase 3 clinical trials have been completed in advanced-illness patients with opioid-induced bowel dysfunction (OBD) using a subcutaneous form of methylnaltrexone.

In early 2007, the companies said they plan to submit a New Drug Application to the Food and Drug Administration for this indication.

If the NDA is approved, Wyeth said it plans a U.S. market launch soon thereafter.

Following the U.S. submission, Wyeth said it plans to complete regulatory filings in Europe and the rest of the world for subcutaneous methylnaltrexone.

The companies said the use of opioid analgesics, such as morphine, often results in OBD, a combination of symptoms including constipation, nausea, abdominal discomfort, bloating and loss of appetite.

OBD occurs when opioids bind to mu-opioid receptors in the gut, reducing gastrointestinal motility.

Wyeth is a pharmaceutical and health care products company with headquarters in Madison, N.J.

Progenics, of Tarrytown, N.Y., is a biopharmaceutical company.

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