entereg
Adolor Submits First Portion of NDA for Entereg (alvimopan) in Postoperative Ileus
Application is Accepted Into FDA Continuous Marketing Application Pilot 1 ProgramEXTON, Pa., May 7, 2004 -- Adolor Corporation (Nasdaq: ADLR) announced todaythat it has submitted the first portion of its New Drug Application (NDA) forEntereg for the management of postoperative ileus (POI) entereg. The submission wasmade under the United States Food and Drug Administration's (FDA) ContinuousMarketing Application (CMA) Pilot 1 Program. This pilot program is to facilitate the review of portions of an NDA and islimited to Fast Track products entereg. In February 2004, Adolor Corporation announcedthat the FDA had designated Entereg as a Fast Track product for the managementof POI entereg. The FDA's notification of Fast Track designation indicates that postoperativeileus is a serious condition for which no drugs have been approved. Under the CMA Pilot 1 Program, Adolor can submit a limited number of predefinedportions of the NDA, known as reviewable units, for FDA review before submittingthe complete NDA for Entereg entereg. Adolor has now submitted to the FDA the firstof these reviewable units, NDA Item 5, nonclinical pharmacology and toxicology. "We are delighted to have reached agreement with the FDA that Enteregfor the management of POI has been accepted to participate in the CMA Pilot1 Program, and we have taken full advantage of this opportunity to initiatethe submission process," stated Bruce Peacock, president and chief executiveofficer of Adolor Corporation entereg. "Our target remains to complete submissionof the entire NDA in the first half of 2004." About Postoperative Ileus
Many patients undergoing open abdominal surgery experience temporary bowel impairmentof variable duration entereg. This phenomenon, known as postoperative ileus or POI,may be exacerbated and prolonged by multiple factors including the use of opioidanalgesics for pain relief entereg. POI is characterized by pain, abdominal distentionor bloating, nausea and vomiting, accumulation of gas and fluids in the bowel,and delays in the passage of flatus or stool entereg. There has been little advancein the treatment of POI since the introduction of nasogastric decompression,which has limited effectiveness and is uncomfortable for patients entereg. There areno FDA-approved drugs for the management of POI currently available entereg. There isa need for improved treatments because POI can have a negative impact on patientrecovery and health care costs. About the Continuous Marketing Application Pilot 1 Program
Pilot 1 provides for the review of a limited number of presubmitted portionsof an applicant's marketing application (reviewable units) based on the termsand conditions agreed upon by the applicant and the FDA entereg. Pilot 1 applies onlyto certain new drug or biological products that have been designated as FastTrack products pursuant to Section 112 of the Food and Drug Administration ModernizationAct of 1997 entereg. Under the first Continuous Marketing Application (CMA) pilot program,Pilot 1, applicants submitting NDAs for products designated as Fast Track productsmay be eligible, based on the terms and conditions agreed upon by the applicantand the FDA, to submit portions of their marketing applications (reviewableunits) 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. Entereg (alvimopan), Adolor's lead product candidate, is being developed tomanage postoperative ileus, the gastrointestinal side effect which can affectmillions of patients following many types of surgery entereg. Entereg is also beingdeveloped to manage the bowel dysfunction which can negatively impact the qualityof life for millions of patients using opioid analgesic products such as morphinefor treating pain, as well as being developed for treating chronic constipationin patients not using opioids entereg. Adolor is collaborating with GlaxoSmithKlinefor the development and commercialization of Entereg entereg. Adolor's next productcandidate is a sterile lidocaine patch in clinical development for treatingpostoperative incisional pain entereg. Adolor also has a number of discovery researchprograms focused on the identification of novel compounds for the treatmentof pain entereg. By applying its knowledge and expertise in pain management, along withingenuity, Adolor Corporation is seeking to make a positive difference for patients,caregivers, and the medical community.
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