Wyeth and Progenics report preliminary methylnaltrexone findings

Wyeth Pharmaceuticals and Progenics Pharmaceuticals have announced the first findings of a phase III trial investigating the use of methylnaltrexone in the management of postoperative ileus (POI) in patients recovering from segmental colectomy surgical procedures.

The preliminary results show that treatment did not achieve the primary end point of the study; a reduction in time to recovery of gastrointestinal function compared to placebo.

Wyeth adds that the study did not demonstrate that the secondary measures of surgical recovery, including time to discharge eligibility, were superior to placebo.

Robert Ruffolo, president of research and development at Wyeth, suggested that despite the initial negative results, the company remained confident in the methylnaltrexone development programme.

“We will continue to develop the methylnaltrexone franchise to help address the unmet medical need of patients suffering with the gastrointestinal side effects of opioids.”

Progenics’ founder and chief executive officer Paul J Maddon illustrated that the firms were currently undertaking the necessary analyses to “determine greater clarity regarding the outcome of the clinical study”.

Over 500 patients were administered with methylnaltrexone intravenously in doses of 12 or 24 mg every six hours.

Also this week, Wyeth Pharmaceuticals has confirmed that it is to undertake additional clinical studies to support European approval for desvenlafaxine as a potential treatment for vasomotor symptoms associated with menopause.