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Dextofisopam fails to meet primary endpoint of midstage IBS trial
Tuesday, September 22 2009 | Comments
What's This?
The investigational, first-in-class compound dextofisopam did not meet the primary efficacy variable of a Phase IIb trial in the treatment of diarrhea-predominant and alternating irritable bowel syndrome (IBS).The study included 324 women with either of these forms of IBS who were randomized to receive 12 weeks of treatment with 100 mg, 200 mg, or 300 mg of dextofisopam twice daily or placebo.
Results of the trial did not show a statistically significant difference between dextofisopam and placebo in the adequate overall relief of IBS symptoms, which was the trial's primary endpoint.
However, Pharmos Corp., the drug's developer, noted that the percentage responding among the patients treated with dextofisopam 200 mg was higher than what was observed during an earlier Phase IIa trial. In that study, which included 141 patients, the dextofisopam 200 mg regimen demonstrated a statistically significant improvement relative to placebo with respect to the primary endpoint of adequate overall relief.
The company also noted that the placebo response rate in the Phase IIb trial was higher than that observed in the Phase IIa trial.
Treatment with dextofisopam 200 mg showed statistical significance and positive trends when compared with placebo in terms of adequate relief of abdominal pain and discomfort and overall IBS symptoms ratings, which were secondary response variables.
This information concerns a use that has not been approved by the Food and Drug Administration.
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