Phase 2 Data From Oral NKTR-118 Presented at American College of Gastroenterology in San Diego
27 Octobre 2009 - 5:35PM
PR Newswire (US)
New Approach to Treat Opioid-Induced Constipation SAN DIEGO, Oct.
27 /PRNewswire-FirstCall/ -- Data from a phase II study
demonstrated that oral NKTR-118 improved lower gastrointestinal
dysfunction by increasing the frequency of bowel movements in
patients with opioid-induced constipation, while simultaneously
preserving opioid-mediated analgesia. NKTR-118, an oral
peripherally-acting opioid antagonist, is an investigational
product candidate in clinical development for the treatment of
opioid-induced constipation. (Logo:
http://www.newscom.com/cgi-bin/prnh/20091027/PH99766LOGO ) In the
phase II double blind, randomized, placebo-controlled study of 208
patients with opioid-induced constipation, NKTR-118 achieved the
primary endpoint of change from baseline in spontaneous bowel
movements (SBMs). Patients receiving either 25 mg or 50 mg of oral
NKTR-118 once daily had a significantly greater change from
baseline in SBMs during the first week of treatment than patients
receiving placebo. The mean change from baseline in SBMs per week
for patients receiving 25 mg NKTR-118 was 3.6 versus 1.9 in the
placebo group (p= 0.002). Patients receiving 50 mg NKTR-118 had a
mean change from baseline in SBMs per week of 4.4 versus 1.9 in the
placebo group (p=0.0001). The increase from baseline in SBMs versus
placebo averaged over the four-week treatment period was
significant for both the 25 mg (p=0.002) and 50 mg (p