EnteregTreatment for Postoperative Ileus
Update: Entereg Now FDA Approved - May 20, 2008
Adolor Submits First Portion of NDA for Entereg
Application is Accepted Into FDA Continuous Marketing Application Pilot 1 Program
EXTON, Pa., May 7, 2004 -- Adolor Corporation (Nasdaq: ADLR) announced today that it has submitted the first portion of its New Drug Application (NDA) for Entereg for the management of postoperative ileus (POI). The submission was made under the United States Food and Drug Administration's (FDA) Continuous Marketing Application (CMA) Pilot 1 Program.
This pilot program is to facilitate the review of portions of an NDA and is limited to Fast Track products. In February 2004, Adolor Corporation announced that the FDA had designated Entereg as a Fast Track product for the management of POI. The FDA's notification of 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 can submit a limited number of predefined portions of the NDA, known as reviewable units, for FDA review before submitting the complete NDA for Entereg. Adolor has now submitted to the FDA the first of these reviewable units, NDA Item 5, nonclinical pharmacology and toxicology.
"We are delighted to have reached agreement with the FDA that Entereg for the management of POI has been accepted to participate in the CMA Pilot 1 Program, and we have taken full advantage of this opportunity to initiate the submission process," stated Bruce Peacock, president and chief executive officer of Adolor Corporation. "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 the Continuous Marketing Application Pilot 1 Program
Pilot 1 provides for the review of a limited number of presubmitted portions of an applicant's marketing application (reviewable units) based on the terms and conditions agreed upon by the applicant and the FDA. Pilot 1 applies only to certain new drug or biological products that have been designated as Fast Track products pursuant to Section 112 of the Food and Drug Administration Modernization Act of 1997. Under the first Continuous Marketing Application (CMA) pilot program, Pilot 1, applicants submitting NDAs for products designated as Fast Track products may be eligible, based on the terms and conditions agreed upon by the applicant and the FDA, to submit portions of their marketing applications (reviewable units) before submitting the complete marketing application.
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: May 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 Second Portion of NDA for Entereg - June 1, 2004