Wyeth and partner Progenics Pharmaceuticals have been hurt by disappointing late-stage data from a trial of their investigational bowel drug methylnaltrexone.
The firms announced preliminary findings from the first of two Phase III trials of intravenous methylnaltrexone being evaluated for the management of postoperative ileus in patients recovering from segmental colectomy surgical procedures. The data showed that the treatment did not achieve the primary endpoint of a reduction in time to recovery of gastrointestinal function (time to first bowel movement) as compared to placebo.
Additionally, the 542-patient study did not show that secondary measures of surgical recovery, including time to discharge eligibility, were superior to placebo.
Wyeth noted that results from a second Phase III trial of the drug are expected by the middle of 2008.Despite the results, Robert Ruffolo, president of R&D at Wyeth, said “we remain confident in the methylnaltrexone development programme”.
Progenics chief executive Paul Madden stated that the firm is conducting “the necessary analyses to determine greater clarity regarding the outcome of this clinical study," adding that the findings are inconsistent with results from a 65-patient Phase II study.
Source: PharmaTimes
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