Wyeth, Progenics test oral methylnaltrexone in phase 2 trial

By Elaine Rigoli

Tampa, Fla., Aug. 22 - Wyeth Pharmaceuticals and Progenics Pharmaceuticals, Inc. have started a phase 2 clinical trial to evaluate once-daily dosing of oral methylnaltrexone for opioid-induced constipation in patients treated with opioids for chronic pain.

Opioid analgesics, such as morphine, are widely used to treat patients with moderate to severe pain. In addition to their ability to palliate pain via their interaction with the central nervous system, these medications also interact with opioid-specific receptors outside the brain and spinal cord, often resulting in constipation.

Methylnaltrexone is a peripheral mu opioid-receptor antagonist designed to reverse the effect of these medications on opioid receptors outside the central nervous system.

Because methylnaltrexone acts outside of the central nervous system, it does not interfere with brain-centered pain relief, according to a news release.

The companies said more than 100 clinical sites in 21 countries are expected to participate in this randomized, double blind, placebo-controlled, parallel-group trial, recruiting about 200 to 400 patients.

The primary efficacy endpoint is the number of spontaneous bowel movements per week for six weeks in the methylnaltrexone and placebo groups compared to baseline.

Completion of the study is expected to take less than a year and to be followed by phase 3 trials starting in 2007.

The companies said they anticipate no change in their previously announced submission date for a New Drug Application to the Food and Drug Administration for oral methylnaltrexone, which is expected to occur in late 2008 or early 2009.

Progenics, based in Tarrytown, N.Y., is a biopharmaceutical company.

Based in Madison, N.J., Wyeth Pharmaceuticals has products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutrition.

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