Adolor Corporation (ADLR) and GlaxoSmithKline (GSK) announced that the U.S. Food and Drug Administration has informed Adolor that the Prescription Drug User Fee Act action date for Adolor’s ENTEREG product has been extended to May 10, 2008. Additionally, Adolor has also submitted an elaborate ENTEREG Risk Management Program to the FDA.
ENTEREG 12 mg capsules were designed specifically for in hospital, short term use. Adolor asserts that this drug is able to accelerate upper and lower gastrointestinal recovery following partial large or small bowel resection surgery. Currently, there are no other FDA approved drugs for this indication.
Michael R. Dougherty, president and CEO of Adolor, stated, “Earlier this week, we submitted to the FDA a revised risk management program for ENTEREG. We believe the program provides appropriate measures to ensure that ENTEREG is used in patients for whom it has demonstrated a favorable benefit:risk profile. We look forward to working with the FDA as it completes its review of our NDA.”
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