Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Wyeth and Progenics have initiated the second of two phase III trials to evaluate the safety and efficacy of intravenous methylnaltrexone for post-operative ileus, after the first phase III trial was launched in September.
Subscribe to our email newsletter
Post-operative ileus (POI) is a temporary impairment of gastrointestinal (GI) function and a common response to abdominal surgical procedures. The companies believe that because many postoperative patients cannot tolerate oral medications, intravenous methylnaltrexone may represent an important therapeutic option.
In a pilot phase II clinical trial previously conducted by Progenics, patients who received methylnaltrexone following segmental colectomy exhibited improvements in clinically important measures of GI recovery, including time to first bowel movement and discharge eligibility from the hospital.
Similar to the first phase III trial, the second study will enroll patients who have undergone segmental colectomy surgery. The primary efficacy end point is duration of POI as measured by time to first bowel movement. The study will also examine safety and other secondary measures of GI recovery, including time to discharge eligibility.
The intravenous form of methylnaltrexone received fast track designation from the FDA in July 2006. A new drug application is planned for intravenous methylnaltrexone in late 2007 or early 2008.