GlaxoSmithKline and Adolor Corporation today provided an update on the alvimopan (Entereg/Entrareg®) development programme.The U.S. Food and Drug Administration (FDA) has requested that additional data be submitted as part of the complete response to the November 6, 2006approvable letter for alvimopan in postoperative ileus (POI). These additional data includethe final results of Study 101684, an extension of the Phase 2b Study 008 of alvimopan in cancer pain patients with opioid-induced bowel dysfunction (OBD), further analysis of results from Study 014 and the final study reports from the two-year carcinogenicity studies in rats and mice, which were conducted to support the OBD indication. The FDA also requested safety data from Adolor’s co-administered study of alvimopan (alvimopan/hydrocodone/APAP), Study 228, as part of the complete response. Adolor has discontinued Study 228 to enable final data collection and analysis.
The FDA has placed the alvimopan Investigational New Drug Applications (INDs) on clinical hold pending submission and analysis of the requested information and notification by the FDA that clinical studies with alvimopan may resume. GSK and Adolor currently have no studies ongoing with alvimopan.
“We are working closely with GSK to complete analyses of these studies and satisfy all requests for data for our complete response,” said Michael R. Dougherty, president and chief executive officer of Adolor. “We now expect that this submission will occur in the third quarter of 2007.”
GSK anticipates providing an update on the development plan for alvimopan in OBD in the third quarter of 2007.
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For more information, visit GlaxoSmithKline on the World Wide Web at www.gsk.com
About Adolor Corporation
Adolor Corporation (Nasdaq:ADLR) is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription pain management products. Entereg® (alvimopan) is Adolor's lead product candidate under development for the management of the gastrointestinal side effects associated with opioid use. Adolor and GlaxoSmithKline (GSK) are collaborating in the worldwide development and commercialization of Entereg® in multiple indications. Adolor also has a number of discovery research programmes 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. For more information, visit www.adolor.com
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