GlaxoSmithKline and Adolor Corporation announced that the US Food and Drug Administration (FDA) has accepted as complete, Adolor?s response to the November 2006 New Drug Application (NDA) approvable letter for Entereg? (alvimopan) for the management of postoperative ileus (POI).
The FDA informed Adolor that the response is considered a complete class 2 response with a Prescription Drug User Fee Act (PDUFA) goal date of February_10, 2008.
?We are very pleased that the FDA has accepted for review the complete response for POI,? said Michael R. Dougherty, president and chief executive officer of Adolor Corporation. ?We remain committed to our goal of bringing this novel treatment to patients and surgeons and look forward to working with the FDA throughout the review.?
Adolor and GSK have also submitted complete responses to the FDA requesting a release of the clinical holds for all alvimopan Investigational New Drug Applications (INDs). The complete responses were received by the Agency on August 13, 2007. A decision with regard to these requests is pending from the FDA. A release of the clinical holds by the FDA is required before the companies can re-initiate any clinical development activities.
?We are continuing to work with Adolor and the regulatory agencies on both the opioid induced bowel dysfunction (OBD) and POI programmes,? said Yvonne Greenstreet, senior vice president of the medicines development centre at GSK. ?GSK has conducted analyses to fully understand the findings from the OBD programme and believe these support the initial step of submitting the request to release the clinical hold.?