FDA Requests Entereg Failed European Study Data, Adolor Says
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA requests Entereg failed European study data, Adolor reports. Alvimopan failed to show statistical significance for the primary endpoint in partner GlaxoSmithKline’s Phase III study. The pending NDA for the postoperative ileus therapy is based on three studies with mixed results
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Adolor will submit data from a failed Phase III study of its postoperative ileus therapy Entereg in response to a request from FDA, the firm announced Jan. 10. FDA's request for information did not constitute an "approvable" or "not approvable" letter, the company said. Submission of the additional study, which was conducted by partner GlaxoSmithKline, is expected to extend the user fee date by three months. Entereg (alvimopan) currently has an action date of April 25. Entereg did not show statistical significance for the primary endpoint of time to recovery of gastrointestinal function in the GSK trial (study 001). The study enrolled 741 bowel reconstruction patients in Europe, Australia and New Zealand. Initial results were released Dec. 23. The hazard ratio was 1.22 for the 6 mg group (p=.042) and 1.13 for the 12 mg group (p=.20). Because the trial design called for multiple dose comparisons to a single placebo group, a p-value of less than .025 would be required to show statistical significance, Adolor explained. GSK's study was intended to support a European Marketing Authorization Application. The NDA is based on three trials with mixed results. In September, Adolor was denied its priority review request for Entereg despite the agent's fast track designation and acceptance into FDA's continuous marketing application Pilot 1 program ( 1 (Also see "GSK/Adolor Entereg Gets Standard Review For Ileus Despite Fast Track Status" - Pink Sheet, 15 Sep, 2004.) , p. 3). GSK and Adolor also have a co-promotion agreement for the anti-thrombotic Arixtra . [Editor's Note: A version of this story first appeared in 2 'The Pink Sheet' DAILY Jan. 11, 2004. Visit our website, www.ThePinkSheetDAILY.com, to sign up for a free trial.] ¨¨ |