Adolor Corporation and GlaxoSmithKline announced that the US FDA has accepted for review the New Drug Application (NDA) for Entereg (alvimopan) capsules.
Adolor completed the submission of the NDA in June 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. With a standard review, the FDA Prescription Drug User Fee Act (PDUFA) target action date is 10 months from the submission date, or April 25, 2005, a GSK release says.
Entereg is the first of a new class of drugs known as peripherally-acting mu opioid receptor antagonists to be accepted by the FDA for NDA review. The NDA for Entereg includes phase 3 clinical data evaluating more than 2,000 patients in three efficacy studies and one safety study. GlaxoSmithKline and Adolor are collaborating on the worldwide development and commercialization of Entereg.
"We believe that the Entereg NDA acceptance is an important milestone," stated David Jackson, senior vice president, research and development of Adolor Corporation. He added, "We are pleased the FDA has accepted and is currently reviewing the NDA for this novel treatment."
"Entereg represents a potential treatment option for patients with postoperative ileus, a gastrointestinal condition that is uncomfortable, slows patient recovery and prolongs hospital stay," said Kevin Lokay, vice president of Oncology and Acute Care at GlaxoSmithKline. "Currently, there are no pharmaceutical products approved to treat POI," he concluded.
Many patients undergoing abdominal surgery experience transient 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 characterized 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, the release added.
Adolor Corporation and GlaxoSmithKline are collaborating on the worldwide development and commercialization of Entereg for POI, opioid-induced bowel dysfunction (OBD) associated with extended use of opioids to treat chronic pain, chronic constipation not associated with opioid use, and irritable bowel syndrome (constipation predominant).