Adolor Corporation and GlaxoSmithKline said a US Food and Drug Administration (FDA) will review Adolor's New Drug Application (NDA) for Entereg (alvimopan), which treats gastrointestinal side effects after surgery.
The FDA's Gastrointestinal Drugs Advisory Committee will review the NDA for Entereg on January 23, 2008 for the proposed indication of acceleration of time to upper and lower following partial large or small bowel resection surgery with primary anastomosis. The meeting will take place at the Hilton Washington DC/Silver Spring, Maryland Ballroom in Silver Spring, Maryland.
Entereg is Adolor's lead product candidate under development for the management of the gastrointestinal side effects associated with opioid use.
Adolor Corporation is a biopharmaceutical company specializing in the discovery, development and commercialisation of novel prescription pain management products. Adolor has a number of discovery and clinical 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.
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.