Entereg
alvimopan
Treatment for Postoperative IleusAdolor 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.
SOURCE: Adolor Corporation
Related Articles:
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 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
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
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