Adolor Entereg Reduces Hospital Stays By 18 Hours, FDA-Requested Study Finds
This article was originally published in Pharmaceutical Approvals Monthly
GlaxoSmithKline/Adolor's postoperative ileus agent Entereg provides a statistically significant reduction in length of hospital stay, according to trial results reported by Adolor Feb. 7
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GlaxoSmithKline and Adolor plan to continue development of Entereg (alvimopan) after the NDA for management of post-operative ileus was deemed "approvable" a second time, the companies said Nov. 6. FDA noted a potential increased risk of cardiovascular events and requested additional 12-month safety data from GSK's ongoing Phase III safety study (76905/014) in opioid-induced bowel dysfunction in chronic cancer pain patients, as well as a risk management plan. The first approvable letter, issued in July 2005, requested additional efficacy data in patients following bowel resection surgery (1Pharmaceutical Approvals Monthly February 2006, p. 9). The response to the first approvable letter was submitted in May 2006; a response to the second letter appears unlikely before the second quarter of 2007, when final data from the 014 study is expected...
FDA requests Entereg failed European study data, Adolor reports. 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
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011