Adolor Corporation and GlaxoSmithKline say that they have received an approvable letter from the US Food and Drug Administration for the gastrointestinal drug, Entereg (alvimopan). However, they will have to provide additional proof of efficacy before the drug can win the green light in the management of a condition known as postoperative ileus, by helping speed up the recovery of GI function after bowel resection surgery.
Although the move will likely signal a delay in Entereg’s approval – as the companies might have to conduct at least one additional clinical study – Adolor’s share price soared by 19% on the Nasdaq Stock Exchange on Friday to a new year-high. The firm explained that the issue could potentially be addressed with positive results from an ongoing clinical trial, known as Study 14CL314. However, the agency has also said that the firm must provide justification that the median reduction in time to gastrointestinal recovery seen in bowel resection patients treated with Entereg is clinically meaningful.
“We intend to request a meeting with the FDA as quickly as possible to discuss the approvable letter and determine the appropriate next steps for the NDA,” said Bruce Peacock, Adolor’s president and chief executive officer.
The firms filed the new drug application for Entereg with the FDA back in June last year [[29/06/04h]].