Adolor Corporation and GlaxoSmithKline announced that Adolor has submitted the complete New Drug Application (NDA) to the Food and Drug Administration (FDA) for Entereg (alvimopan) capsules. Adolor is seeking marketing approval of Entereg for the management of postoperative ileus (POI) by accelerating time to recovery of gastrointestinal (G.I.) function following abdominal or pelvic surgeries.

"One of our key targets for 2004 was to submit this application in the first half of this year. The completion of the entire NDA submission for Entereg represents a significant milestone achievement for Adolor," stated David Jackson, senior vice president, research and development of Adolor Corporation. "We look forward to working with the FDA during the review of the application," he added.

The FDA granted Fast Track designation to Entereg in February 2004 for use in the management of POI, indicating that POI is a serious medical condition and that there are no drugs currently approved for this condition. Adolor is participating in the FDA's Continuous Marketing Application Pilot 1 Programme. This is an FDA programme available to drug candidates that have received Fast Track designation and allows for completed portions of an NDA to be submitted on an ongoing basis.

Adolor previously submitted NDA Item 5, non-clinical pharmacology and toxicology, and NDA Item 4, chemistry, manufacturing and controls, to the FDA. Adolor now has submitted the complete NDA, which includes phase 3 clinical data evaluating more than 2,000 patients in three efficacy studies and one safety study.

"We are pleased to collaborate with Adolor on the worldwide development of Entereg for POI," said Kevin Lokay, vice president of Oncology and Acute Care at GlaxoSmithKline. He added, "The NDA submission is an important advancement in our joint commitment to research and develop this therapy to help accelerate the recovery of surgical patients."

Entereg is the first of a new class of drugs known as peripherally-acting mu opioid receptor antagonists that has been submitted to the FDA for NDA review.

Many patients undergoing abdominal surgery experience temporary gastrointestinal impairment. This condition, known as postoperative ileus, may be exacerbated and prolonged by multiple factors including the use of opioid analgesics for pain relief.

GlaxoSmithKline and Adolor are collaborating on the worldwide development and commercialization of Entereg.