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Home » WYETH, PROGENICS BEGIN TRIAL OF METHYLNALTREXONE
WYETH, PROGENICS BEGIN TRIAL OF METHYLNALTREXONE
August 22, 2006
Wyeth and Progenics Pharmaceuticals have begun a Phase II trial to evaluate once-daily dosing of oral methylnaltrexone. This trial is designed to identify the dose of methylnaltrexone to be used in Phase III clinical studies that will evaluate the efficacy, safety and tolerability 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. Because methylnaltrexone acts outside of the central nervous system, it does not interfere with pain relief.
More than 100 clinical sites in 21 countries are expected to participate in this randomized, double-blind, placebo-controlled, parallel-group trial, recruiting 200 to 400 patients. After discussions with the FDA, the companies elected to employ an adaptive trial design. The companies anticipate submitting a new drug application in late 2008 or early 2009.
KEYWORDS Drug Pipeline Alert
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