EnteregTreatment for Postoperative Ileus
Update: Entereg Now FDA Approved - May 20, 2008
Adolor Submits Second Portion of NDA for Entereg
EXTON, Pa., Jun 1, 2004 -- Adolor Corporation (Nasdaq: ADLR) announced today that it has submitted the second reviewable unit of its New Drug Application (NDA) for Entereg for the management of postoperative ileus (POI). The submission of NDA Item 4, Chemistry, Manufacturing and Controls (CMC), was made under the United States Food and Drug Administration's (FDA) Continuous Marketing Application (CMA) Pilot 1 Program. The CMA Pilot 1 Program is limited to Fast Track products. Entereg received Fast Track designation from the FDA in February 2004, for use in the management of POI. The FDA's Fast Track designation indicates that postoperative ileus is a serious condition for which no drugs have been approved.
Under the CMA Pilot 1 Program, Adolor Corporation and the FDA agreed that Adolor Corporation could submit two predefined portions of the NDA, known as reviewable units, for FDA review before submitting the complete NDA for Entereg. The Company submitted the first of the two reviewable units, NDA Item 5, Non Clinical Pharmacology and Toxicology, to the FDA in May of this year.
"Chemistry, Manufacturing and Controls is an important component of an NDA and we are pleased to report that we have submitted the CMC section of the Entereg NDA to the FDA," stated Bruce Peacock, President and Chief Executive Officer of Adolor Corporation. "It was early in May that Entereg for the management of postoperative ileus was accepted into the CMA Pilot 1 Program and we have already submitted both of the two planned reviewable units. Our target remains to complete submission of the entire NDA in the first half of 2004."
About Postoperative Ileus
Many patients undergoing open abdominal surgery experience temporary bowel impairment of variable duration. This phenomenon, known as postoperative ileus or POI, may be exacerbated and prolonged by multiple factors including the use of opioid analgesics for pain relief. POI is characterized by pain, abdominal distention or bloating, nausea and vomiting, accumulation of gas and fluids in the bowel, and delays in the passage of flatus or stool. There has been little advance in the treatment of POI since the introduction of nasogastric decompression, which has limited effectiveness and is uncomfortable for patients. There are no FDA-approved drugs for the management of POI currently available. There is a need for improved treatments because POI can have a negative impact on patient recovery and health care costs.
About Adolor Corporation
Adolor Corporation is a biopharmaceutical company specializing in the discovery, development and commercialization of prescription pain management products. Entereg (alvimopan), Adolor's lead product candidate, is being developed to manage postoperative ileus, the gastrointestinal side effect which can affect millions of patients following many types of surgery. Entereg is also being developed to manage the bowel dysfunction which can negatively impact the quality of life for millions of patients using opioid analgesic products such as morphine for treating pain, as well as being developed for treating chronic constipation in patients not using opioids. Adolor is collaborating with GlaxoSmithKline for the development and commercialization of Entereg. Adolor's next product candidate is a sterile lidocaine patch in clinical development for treating postoperative incisional pain. Adolor 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.
Posted: June 2004
- Adolor and GlaxoSmithKline Announce FDA Approval of Entereg (alvimopan) for the Management of Postoperative Ileus (POI) - May 21, 2008
- 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 CommitteeMeeting for Entereg (alvimopan) for the Management of PostoperativeIleus in Bowel Resection - January 24, 2008
- Adolor Announces Availability of Briefing Documents For January23rd FDA Advisory Committee Meeting on Entereg (alvimopan) - January 18, 2008
- Adolor and GlaxoSmithKline Announce FDA Advisory Committee toReview Entereg (alvimopan) for the Management of PostoperativeIleus (POI) - November 28, 2007
- FDA Accepts for Review Complete Response to Approvable Letter forEntereg (alvimopan) for POI - August 28, 2007
- GSK and Adolor Update Alvimopan (Entereg/Entrareg) DevelopmentProgram - 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
- FDA Accepts Entereg for Review - September 8, 2004
- Adolor Completes Submission of NDA for Entereg - June 28, 2004
- Adolor Submits First Portion of NDA for Entereg - May 7, 2004