Wyeth and Progenics announce new trial for methylnaltrexone

Wyeth and its development partner Progenics have announced the details of a planned phase II clinical trial for oral methylnaltrexone for the treatment of opioid-induced constipation (OIC).

Utilising more than 100 clinical sites across 21 countries, the new trial will evaluate dosages for the drug before full phase III clinical trials studying safety, efficacy and tolerability can be considered.

Between 200 and 400 patients will be recruited, who will be monitored for the number of spontaneous bowel movements over a six week period for comparison with a placebo group.

Gary L Stiles, executive vice-president and chief medical officer at Wyeth, remarked: “Our phase II trial is designed to enable Wyeth and Progenics to efficiently determine which of the five tested doses of oral methylnaltrexone will be most appropriate for further evaluation.”

“By using an adaptive trial design, we may have the potential to enrol fewer patients than with a traditional approach, thus potentially accelerating the transition into phase III studies,” he added.

Methylnaltrexone is designed to reverse the effects of opioid drugs on mu opioid receptors outside the nervous system. Because it is intended to operate outside the nervous system, pain relief should not be affected by drug.

Last month, methlynaltrexone was given fast-track status by the FDA, reserved for drugs where an expedited review process is deemed beneficial for patients with diseases where there is an unmet clinical need.

Progenics and Wyeth claim that opioid-induced constipation is a major source of prolonged hospital stays following gastrointestinal and colon surgery. The disorder results in patients being unable to tolerate oral foods and medicines.

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