Phase 2 Data From Oral NKTR-118 Presented at American College of Gastroenterology in San Diego

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