EnteregTreatment for Postoperative Ileus
Update: Entereg Now FDA Approved - May 20, 2008
Adolor Announces Availability of Briefing Documents For January23rd FDA Advisory Committee Meeting on Entereg (alvimopan)
EXTON, Pa.--(BUSINESS WIRE)--Jan 18, 2008 - Adolor Corporation announced today that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the scheduled Gastrointestinal Drugs Advisory Committee (GIDAC) meeting to review Adolor's New Drug Application (NDA) for Entereg(R) (alvimopan) for the proposed indication of acceleration of time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis.
The GIDAC meeting is scheduled for 8:00 am EST on Wednesday, January 23, 2008. The Prescription Drugs User Fee Act (PDUFA) action date for the Entereg NDA is February 10, 2008. The briefing information can be accessed at: http://www.fda.gov/ohrms/dockets/ac/acmenu.htm
About Adolor Corporation
Adolor Corporation (Nasdaq:ADLR) is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription pain management products. Adolor has two lead product candidates in development: Entereg(R) (alvimopan) for the management of the gastrointestinal side effects associated with opioid use; and, novel Delta opioid receptor agonists for a variety of pain indications. Adolor and GlaxoSmithKline are collaborating in the worldwide development and commercialization of Entereg in multiple indications. Adolor and Pfizer are collaborating in the worldwide development and commercialization of two Delta agonists for 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 is seeking to make a positive difference for patients, caregivers and the medical community.
This release and the briefing information, and oral statements made with respect to information contained in this release and the briefing information, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those which express plan, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact. These statements are based upon management's current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Such known risks and uncertainties relate to, among other factors: the risk that the advice from the Gastrointestinal Drug Advisory Committee meeting is not favorable; the risk that Adolor may not receive regulatory approval of Entereg (R) (alvimopan) for POI, OBD, or any other indication; the risk that the February 10, 2008 PDUFA date is extended or not met; the risk that Adolor may not be able to adequately address the deficiencies in the November 2006 FDA approvable letter; the risk that a risk management plan could materially adversely affect the commercial prospects for Entereg, if regulatory approval is achieved; the risk that Adolor may not obtain FDA approval for Entereg in POI, whether due to Adolor's inability to provide additional data satisfactory to the FDA to obtain approval for the NDA, the adequacy of the safety and efficacy data from all of the Entereg studies, changing regulatory requirements, the risk that the FDA may not agree with Adolor's and GSK's analyses of the Entereg studies (including Study 014) and may evaluate the results of these studies by different methods or conclude that the results from the studies, whether or not statistically significant, do not support safety, efficacy, a favorable risk/benefit profile, or there were human errors in the conduct of the studies, or otherwise; adverse safety findings in any Entereg studies; the risk that the alvimopan Investigational New Drug Applications (INDs) remain on clinical hold indefinitely; the risk that filing targets for regulatory submissions or user fee goal dates are not met; the risk that the results of other clinical trials of Adolor's drug product candidates, including Entereg, are not positive; the risk of product liability claims; reliance on third party manufacturers; the costs, delays and uncertainties inherent in scientific research, drug development, clinical trials and the regulatory approval process; Adolor's history of operating losses since inception and its need for additional funds to operate its business; Adolor's reliance on its collaborators, including GSK, in connection with the development and commercialization of Entereg; market acceptance of Adolor's products, if regulatory approval is achieved; competition; and securities litigation.
Posted: January 2008
- 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 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
- Adolor Submits First Portion of NDA for Entereg - May 7, 2004