EXTON, PA and PHILADELPHIA, PA -- (Marketwire) -- 08/20/09 -- Adolor Corporation (NASDAQ: ADLR) and GlaxoSmithKline (NYSE: GSK) today announced that an economic
analysis of Phase 3 clinical trial data reported that the use of ENTEREG
after bowel resection surgery decreased the amount of time patients spent
in the hospital by one day, resulting in lower estimated hospital costs
compared with placebo. The results, published in the American Journal of
Health-System Pharmacy, were based on a post-hoc pharmacoeconomic analysis
of pooled data consisting of 1,409 patients who participated in four
randomized, double-blind, placebo-controlled, Phase 3 efficacy studies of
ENTEREG conducted in North America.
ENTEREG is the first and only FDA-approved therapy indicated to accelerate
the time to upper and lower gastrointestinal recovery following partial
large or small bowel resection surgery with primary anastomosis, or
reconnection of the intestine.
"The results from this analysis are positive for both bowel resection
patients and healthcare providers," said Anthony J. Senagore, M.D., Vice
President, Research and Education, Spectrum Health, Grand Rapids, MI, and
one of the study authors. "The analysis of these Phase 3 North American
studies concluded that using ENTEREG contributed to earlier discharge after
surgery and, importantly, reduced overall estimated hospital costs."
Analysis design and results
Patients evaluated in the four Phase 3 trials received standardized
accelerated care treatment -- removal of nasogastric tube before first
postoperative dose, early ambulation, and early feeding. Both placebo and
ENTEREG were given orally once before surgery and then twice daily
beginning the day after surgery until hospital discharge or for a maximum
of 15 doses. Patients were eligible to participate if they were 18 years
of age or older, were undergoing laparotomy for partial small or large
bowel resection with primary anastomosis, and were scheduled for
postoperative pain management with IV opioid-based analgesia.
This post-hoc pooled economic analysis showed that patients in the group
receiving ENTEREG experienced a mean hospital length of stay (defined as
the day of surgery to day that the discharge order was written) of one day
less than the placebo control group. In the four North American Phase 3
trials, mean time-to-discharge-order written (which represented LOS) for
patients receiving ENTEREG was between 13-21 hours shorter compared to
those in the control group. In those trials, the time in hours from the
end of surgery to when the discharge order was written represented the LOS.
Mean estimated hospital costs were less for patients taking ENTEREG
compared to the control group.
"We are very pleased to see these results published, as they reinforce our
belief in the value proposition of ENTEREG," said Eliseo Salinas, MD, MSC,
Senior Vice President, Research and Development and Chief Medical Officer
at Adolor. "This encouraging pharmacoeconomic analysis was conducted in a
setting where steps were being taken to help bowel resection patients
recover gastrointestinal function faster, and those using ENTEREG clearly
saw benefit compared to placebo. We look forward to seeing the results of
independently-conducted analyses on the potential health economic benefits
of ENTEREG in real world clinical settings."
Such an independent analysis was presented recently at the 2009 Annual
Meeting of the Northwest Society of Colon and Rectal Surgeons in Sun River,
Oregon, by Timothy Beard, MD, FACS.* Dr.
