Sucampo Pharmaceuticals, Inc. ("Sucampo") (NASDAQ: SCMP) and Abbott (NYSE: ABT) today reported data from a phase 3 clinical efficacy trial in 124 Japanese chronic idiopathic constipation (CIC) patients as well as from a phase 3 long-term safety trial in an additional 209 Japanese CIC patients. The purpose of the studies was to confirm the treatment effect and safety profile of lubiprostone capsules in Japanese CIC patients.
The primary endpoint of the efficacy trial, a change from baseline in the number of spontaneous bowel movements (SBMs) at the end of the first week of treatment, was met by the patients taking 24-mcg lubiprostone twice a day (p<0.001 vs. placebo treatment). Lubiprostone was shown to be well-tolerated and there were no reported severe adverse effects in either trial.
The secondary endpoints of the efficacy trial included the change from baseline in the weekly average number of SBMs at Weeks 2, 3 and 4, and scores in the short form 36 (SF-36) questionnaire and the irritable bowel syndrome quality of life (IBS-QOL) questionnaire. The aim of the long-term safety trial was a comparison of quality of life scores at baseline and after treatment.
Data describing the results of the two trials were the subject of poster #DDW/AGA 1038006, titled Lubiprostone Improves Not Only Spontaneous Bowel Movement But Also Quality of Life in Patients with Chronic Idiopathic Constipation: Phase III Randomized, Double-Blind, and Placebo-Controlled Study and Long-Term Treatment Study In Japan, were reported at the annual Digestive Disease Week (DDW) conference, held in Chicago, Illinois, and included these highlights:
- In the four-week efficacy clinical trial:
- Patients treated with lubiprostone had a statistically significant (p<0.001) change from baseline at Week 1 in the average number of reported SBMs (change from baseline of 3.7 in the lubiprostone arm vs. 1.3 in the placebo arm).
- Lubiprostone treated patients had statistically significant changes from baseline in the weekly SBM frequency at Weeks 2, 3 and 4 (p<0.001 at Week 2; p<0.01 at Week 3; and, p<0.05 at Week 4) when compared to placebo.
- Improvement in stool consistency also was statistically significant (p<0.001) in the lubiprostone group at all study weeks.
- In a comparison of time to first SBM following initiation of therapy, the lubiprostone group had a statistically significant (p<0.01) increase in the proportion of patients reporting first SBMs within 24 hours as compared to placebo.
- Patients' "global assessment of treatment effectiveness" was significantly improved for lubiprostone-treated patients vs. those treated with placebo over the duration of the study.
- In the 48 week open-label, long-term safety trial:
- Throughout the 48-week treatment period, patients reported a statistically significant increased average number of weekly SBMs (p<0.001) than were observed at baseline.
- As compared to baseline evaluation of quality of life measures, lubiprostone treatment resulted in better SF-36 and IBS-QOL scores overall. Specifically, lubiprostone-treated patients reported statistically significant improvements in the following domains of the SF-36 questionnaire at Week 48: physical function (p<0.01), bodily pain (p<0.001), general health (p<0.001), and emotional role (p<0.05); lubiprostone scored significantly (p<0.001) in each domain within the IBS-QOL questionnaire.
Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman and Chief Executive Officer of Sucampo Pharmaceuticals, said, "We are excited that these data confirm results of previous clinical trials of lubiprostone in Japanese patients and that they are similar to prior clinical results in a more ethnically diverse patient population. Lubiprostone appears to be a promising agent for Japanese CIC patients."
Gary Winer, Vice President, Abbott Japan, which holds commercialization rights to lubiprostone in Japan, said, "The combined results of the phase III efficacy trial and the long-term safety study of AMITIZA highlight an important new treatment for people in Japan suffering from chronic idiopathic constipation. We are excited to bring such a promising new product to the Japanese market."
Source: Sucampo Pharmaceuticals, Inc.