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Ibodutant improves IBS-D symptoms in women
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Ibodutant, a selective neurokinin-2 receptor antagonist, significantly improved overall symptoms, abdominal pain and stool pattern in women with diarrhea-predominant irritable bowel syndrome, according to phase 2 trial results.
“Based on ... preclinical findings, it has been speculated that NK2 receptor antagonists could be useful in the treatment of symptoms of IBS,” the researchers wrote. “Furthermore, in a phase 2 dose-finding study, the selective tachykinin NK2 receptor antagonist, ibodutant [Menarini Ricerche], showed benefit over placebo in patients with diarrhea-predominant IBS and a baseline pain severity score >1.”
This double blind, randomized, placebo-controlled, parallel-group study was performed at 71 sites spanning eight European countries from October 2010 through May 2012. After a 2-week run-in period, researchers randomly assigned 559 patients with IBS-D 1 mg, 3 mg or 10 mg ibodutant or placebo once daily for 8 weeks. Satisfactory (75% of the study weeks) improvements in overall IBS symptoms and abdominal pain/discomfort served as the dual primary endpoints.
The researchers observed a dose-dependent efficacy response, but none of the ibodutant doses were statistically superior to placebo. However, when analyzing each sex separately, they found that women had a dose-dependent efficacy response that reached statistical superiority over placebo at the 10 mg dose (P = .003). No such effect was observed in men.
Analysis using abdominal pain and stool consistency response endpoints endorsed by the FDA showed superior improvements in stool consistency in the overall population at the 10 mg dose. Moreover, 54.5% of the women who received 10 mg ibodutant vs. 31.2% of those who received placebo were abdominal pain and stool consistency responders (P = .003).
“The tolerability and safety of ibodutant was excellent at all doses,” the researchers wrote.
They concluded that these results demonstrate the efficacy, safety and tolerability of 10 mg ibodutant in women with IBS-D, whereas no efficacy was demonstrated in men in the dose range studied. Further evaluation of ibodutant in women with IBS-D is therefore warranted, they wrote. – by Adam Leitenberger
Disclosure: Several researchers report they are employees of Menarini Pharmaceuticals.
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