GlaxoSmithKline (NYSE: GSK) and Adolor Corporation (Nasdaq: ADLR) announced that the Food and Drug Administration (FDA) has issued a letter stating that the new drug application (NDA) for Entereg (alvimopan 12mg) for the management of post operative ileus (POI) is approvable. The FDA has requested 12-month safety data, including analysis of serious cardiovascular events, from study 014 (767905/014), an ongoing safety study in opioid-induced bowel dysfunction (OBD). The FDA also requested a risk management plan as part of the submission.
Study 014 is an ongoing Phase 3, blinded, long-term (12 month) safety study conducted by GSK evaluating alvimopan 0.5 mg. twice daily for the treatment of opioid-induced bowel dysfunction in patients with chronic non-cancer pain. The study is targeted for completion late in the first quarter of 2007, with final data available in the second quarter.
The FDA?s review of the NDA for POI included the six-month interim analysis of Study 014. This analysis was submitted in late September 2006 and showed an increase, which was not statistically significant, in the reported incidence of serious cardiovascular adverse events in patients receiving alvimopan relative to placebo. The reported events were in patients at high risk for cardiovascular disease, did not appear to be linked to duration of dosing and were consistent with epidemiological expectations for the subject population. Combined results from all completed studies in the chronic population submitted by GSK to the FDA did not support a conclusion that patients taking alvimopan were at increased risk for serious cardiovascular events.
?We will meet with the FDA to discuss the approvable letter and work with GSK to provide the additional information requested as expeditiously as possible,? said David Madden, Interim President and Chief Executive Officer of Adolor.
?We continue to believe that Entereg has significant potential to benefit patients at risk of developing POI and those suffering from OBD and remain committed to its continued development,? said Yvonne Greenstreet, Senior Vice President, Research and Development, GlaxoSmithKline.
Conference Call Information
Adolor will host an audio only conference call on November 6, 2006at 8:30 a.m.Eastern Time to discuss the NDA approvable letter. To access this call and have the opportunity to pose questions, dial 1-800-638-4930 for domestic callers, and 1-617-614-3944 for international callers, and provide the Passcode 55545189. The call will also be available on the Investor Relations section of the Company’s website, www.adolor.com.
An audio replay of the conference call will be available beginning at 10:30 a.m.Eastern Time on November 6, 2006. To listen to a replay of the conference call, dial 1-888-286-8010 (domestic callers) or 1-617-801-6888 (international callers) with a Passcode of 29264969 or listen via the website. The replay will be available for one week.
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 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. For more information, visit www.adolor.com.
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.