Takeda, Sucampo Report Results For Two Phase 3 Trials

Sucampo and Takeda have reported top-line results from two identically-designed phase 3 clinical trials of lubiprostone (24 mcg, twice daily). The drug is for the management of opioid-induced bowel dysfunction (OBD) in patients with chronic, non-cancer pain.

In the study OBD0631 (631), the primary endpoint of a statistically significant change from baseline in the frequency of spontaneous bowel movements (SBMs) at week eight of treatment, was met when lubiprostone was compared to placebo.

The result showed that the study did not achieve statistical significance for the same primary endpoint. Statistically significant improvements with lubiprostone were achieved for two of the secondary endpoints, and positive trends were observed in four of the other secondary endpoints.

Reportedly, there was a high rate of response in the placebo arm of the 632 trial. Approximately, 58% of subjects treated with placebo in the 632 trial experienced more than three SBMs per week, during each week of the trial.

Gayle Dolecek, senior vice president of R&D at Sucampo, said: “Given the results in the two studies, we are continuing further analysis of the data. However, these results suggest that lubiprostone may have the potential to treat the symptoms of OBD, for which there is currently no approved drug.”