GSK Submits Response to FDA for Entereg Approvable Letter

GlaxoSmithKline (GSK) and partner Adolor submitted their complete response to a second FDA approvable letter for investigational drug Entereg for the management of postoperative ileus, a common complication with gastrointestinal surgery, the companies announced earlier this week.

The new FDA action date for the Entereg (alvimopan) new drug application (NDA) is Feb. 10, 2008, the companies said. The product is an opioid receptor antagonist.

The most recent Entereg approvable letter was issued last year and requested additional safety data from what was at the time an ongoing clinical trial. In June, the firms announced that the FDA requested additional clinical study data to be included in the complete response. The original NDA was submitted in 2004.

Safety issues have recently plagued development of the product. Earlier this summer, the FDA placed a clinical hold on all Entereg investigational new drug applications. Before the product was placed on hold, the firms suspended various clinical studies, including a study in patients with opioid-induced bowel problems, and a study involving cancer patients, due to a potential safety signal for tumors.

In mid-August the firms submitted their complete responses to the FDA regarding the clinical holds, requesting that the product be released for further study, Adolor said. The company said that it could receive a decision from the FDA in September.