Entereg
alvimopan
Treatment for Postoperative IleusFDA Accepts Entereg for Review
EXTON, Pa. and PHILADELPHIA, September 08, 2004 -- Adolor Corporation (NASDAQ:ADLR) and GlaxoSmithKline (NYSE:GSK) announced today that the U.S. Food and Drug Administration (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.
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, M.D., senior vice president, research and development of Adolor Corporation. "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."
About Postoperative Ileus (POI)
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.
Entereg Collaboration
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).
About Adolor Corporation
Adolor Corporation (NASDAQ:ADLR) is a biopharmaceutical company
specializing in the discovery, development and commercialization of
novel prescription pain management products. Entereg (alvimopan) is
Adolor's lead product candidate. Adolor is developing a sterile
lidocaine patch which is in Phase 2 clinical development for
post-incisional pain. Adolor Corporation also has a number of
discovery research programs focused on the identification of novel
compounds for the treatment of pain. By applying its knowledge and
expertise in pain management, along with ingenuity, Adolor
Corporation is seeking to make a positive difference for patients,
caregivers and the medical community.
For more information, please visit www.adolor.com.
About GlaxoSmithKline
GlaxoSmithKline (NYSE:GSK) is one of the world's leading
research-based pharmaceutical and healthcare companies.
GlaxoSmithKline is committed to improving the quality of human life
by enabling patients to do more, feel better and live longer.
For more information, please visit www.gsk.com.
Related Articles:
Adolor Provides Regulatory Update on Entereg (alvimopan) - May 9, 2008
FDA Extends Review of NDA for Entereg (alvimopan) - February 11, 2008
Adolor and GlaxoSmithKline Report Favorable FDA Advisory Committee Meeting for Entereg (alvimopan) for the Management of Postoperative Ileus in Bowel Resection - January 24, 2008
Adolor Announces Availability of Briefing Documents For January 23rd FDA Advisory Committee Meeting on Entereg (alvimopan) - January 18, 2008
Adolor and GlaxoSmithKline Announce FDA Advisory Committee to Review Entereg (alvimopan) for the Management of Postoperative Ileus (POI) - November 28, 2007
FDA Accepts for Review Complete Response to Approvable Letter for Entereg (alvimopan) for POI - August 28, 2007
GSK and Adolor Update Alvimopan (Entereg/Entrareg) Development Program - June 11, 2007
FDA Issues Approvable Letter for Entereg (alvimopan) for POI - November 6, 2006
Adolor’s Complete Response to Approvable Letter Accepted for Review by FDA - May 31, 2006
Adolor Receives FDA Approvable Letter for Entereg - July 22, 2005
Adolor Announces FDA Update - January 10, 2005
Adolor Completes Submission of NDA for Entereg - June 28, 2004
Adolor Submits Second Portion of NDA for Entereg - June 1, 2004
Adolor Submits First Portion of NDA for Entereg - May 7, 2004
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