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news.The FDA is to restart its review of Adolor Corporation and GlaxoSmithKline's application for Entereg to be approved for the treatment of post operative ileus after the companies submitted more information to back-up the efficacy of the drug.
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In July 2005 the FDA issued an approvable letter for Entereg, an investigational drug under review for the management of postoperative ileus (POI) by acceleration of the time to recovery of gastrointestinal (GI) function following bowel resection surgery.
The FDA indicated in the letter that before the NDA may be approved, it was necessary to provide additional proof of efficacy to support the proposed use of Entereg following bowel resection surgery.
The FDA indicated that this may be achieved by demonstrating statistically significant results in at least one additional clinical study, and that this could potentially be addressed with the positive results from Adolor's study 14CL314. The FDA also indicated that Adolor must provide justification that the median reduction in time to gastrointestinal recovery seen in bowel resection patients treated with Entereg is clinically meaningful.
“We are pleased the Agency has accepted the complete response for review,” stated Dr James Barrett, senior vice president, chief scientific officer and president, research of Adolor Corporation. “The early achievement of this milestone takes us one step closer to achieving our goal of bringing this novel treatment to patients and surgeons. We look forward to working with the Agency throughout the review.”