GSK/Adolor Entereg Gets Standard Review For Postoperative Ileus Despite Fast Track Status
This article was originally published in The Pink Sheet Daily
Executive Summary
NDA submission was completed June 25 under FDA's continuous marketing application Pilot 1 program. There are no approved POI treatments, firm says. Chronic constipation and opioid bowel dysfunction alvimopan filings are projected for 2007.
You may also be interested in...
Adolor's Entereg "Approvable"; Ongoing Study May Provide Confirmatory Data
FDA is requesting that the company confirm efficacy of the postoperative ileus therapy. An ongoing Phase III trial with Entereg could address FDA's concerns.
Adolor's Entereg "Approvable"; Ongoing Study May Provide Confirmatory Data
FDA is requesting that the company confirm efficacy of the postoperative ileus therapy. An ongoing Phase III trial with Entereg could address FDA's concerns.
FDA Requests Entereg Failed Study Data, Adolor Says
Alvimopan failed to show statistical significance for the primary endpoint in partner GlaxoSmithKline’s Phase III study. The pending NDA for the postoperative ileus therapy is based on three studies with mixed results.