Adolor completes NDA for Entereg

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

POI is a temporary impairment of GI function, which can occur following many types of surgery. GlaxoSmithKline and Adolor are collaborating on the worldwide development and commercialisation of Entereg.

'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 Dr 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.'

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 Program. This is an FDA program available to drug candidates that have received Fast Track designation and allows for completed portions of an NDA to be submitted on an on-going basis.

Adolor previously submitted NDA Item 5, nonclinical pharmacology and toxicology, and NDA Item 4, chemistry, manufacturing and controls, to the FDA. Adolor now has submitted the complete NDA, which includes Phase III 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. '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.

About Postoperative Ileus (POI)

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. POI is characterised by abdominal distension and pain, nausea and vomiting, reduced desire to eat, and an inability to pass gas or stool. POI is a major contributor to prolonged hospital stays. Consequently, POI represents a substantial burden on healthcare resources. Despite the negative impact, there have been few advances in the treatment of POI since the introduction of nasogastric decompression over 100 years ago, which has limited effectiveness and is uncomfortable for patients. Currently, there are no drugs approved for the management of POI.

Collaboration

Adolor Corporation and GlaxoSmithKline are collaborating on the worldwide development and commercialisation of Entereg for POI, opioid-induced bowel dysfunction (OBD) associated with extended use of opioids to manage cancer pain or chronic non-cancer pain, chronic constipation not associated with opioid use, and irritable bowel syndrome (constipation predominant).