Adolor: FDA accepts response to Entereg NDA letter

By Elaine Rigoli

Tampa, Fla., May 31 - Adolor Corp. and GlaxoSmithKline announced that the Food and Drug Administration has accepted as complete, Adolor's response to the July 2005 New Drug Application approvable letter for Entereg for the management of post-operative ileus (POI).

The FDA informed Adolor that the response is considered a class 2 resubmission with a user fee goal date of Nov. 9, 2006.

On July 21, 2005 the FDA issued an approvable letter for Entereg (alvimopan), an investigational drug under review for the management of POI by acceleration of the time to recovery of gastrointestinal 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, according to a news release.

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, the release said.

Adolor is a biopharmaceutical company based in Exton, Pa.

GlaxoSmithKline is a research-based pharmaceutical company based in London.

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