GSK/Adolor Entereg Gets Standard Review For Ileus Despite Fast Track Status
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
GlaxoSmithKline/Adolor’s non-opioid analgesic Entereg did not receive a priority review as requested; Adolor announced a standard review for the postoperative ileus NDA Sept. 8.
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Adolor expects to complete submission of Entereg (alvimopan) for postoperative ileus in the first half of 2004. The firm recently announced FDA's acceptance of the non-opioid analgesic into its continuous marketing application (CMA) Pilot 1 program, which allows sponsors of fast-track products to submit NDAs in portions (1Pharmaceutical Approvals Monthly March 1, 2004, p. 4). The Exton, Pa.-based firm has so far submitted two "reviewable units": nonclinical pharmacology/toxicology (announced May 7) and chemistry, manufacturing & controls (announced June 1). GlaxoSmithKline will co-promote the product in the U.S. and take the lead on development for opioid-induced bowel dysfunction (2Pharmaceutical Approvals Monthly Oct. 1, 2003, p. 15)...