Cilansetron has been withdrawn from USA consideration as of November, 2005 after receiving a "not approvable" action letter from the FDA requesting additional clinical trials. There is no information about future trials currently available.
Cilansetron (brand name Calmactin) is a prescription drug currently being tested in clinical trials. Solvay Pharmaceuticals, the makers of Cilansetron (Calmactin), have announced that headline results from the first two large placebo-controlled phase III efficacy studies show convincing evidence for the patient benefits of Cilansetron (Calmactin), for the treatment of Irritable Bowel Syndrome that is diarrhea-predominant.
Cilansetron ~ What is it?
Solvay is currently running a full phase III clinical program with Calmactin (cilansetron), a potent and selective 5HT3 antagonist that affects serotonin action in the gut. (Serotonin is involved in the regulation of visceral pain via 5-HT3 receptors located in the lower gastrointestinal tract.) More than 4,000 patients have been entered into phase III clinical studies. In two Phase II placebo controlled clinical studies and two Phase III placebo controlled clinical studies conducted in the US, Europe and other countries, Calmactin (cilansetron) has shown clinical benefits in both males and females.
Cilansetron Clinical Trials
A double-blind, placebo-controlled, 12-week randomized Phase II study in the U.S. of Calmactin (cilansetron), at doses varying from 1 mg to 16 mg three times per day, was reported in an abstract at the May 2001 meeting of Digestive Disease Week (DDW). Calmactin (cilansetron) is being developed to reduce abdominal pain, decrease stool frequency, and increase firmness of stool in IBS patients who are diarrhea-predominant. Phase II studies evaluate drug dosage, as well as effectiveness and side effects. The study involved a total of 471 non-constipated IBS patients, both male (35%) and female (65%). Calmactin (cilansetron) was found to be more effective than placebo in both men and women in providing adequate symptom relief. Effectiveness varied by dosage. Constipation and flatulence were the most frequent side effects. None of the constipation cases were judged to be serious and no cases of ischemic colitis were reported during the study. Another similar study of 435 IBS patients in Canada and Europe reported similar results. Solvay Pharmaceuticals started the Calmactin (cilansetron) phase III clinical program worldwide in late 2001.
Cilansetron Sales & Profits
"We hope to start launching [Calmactin] in early 2005," a spokesman for Solvay has said. He also reiterated that Calmactin (cilansetron), could reach peak sales of at least 250 million euros ($291.6 million US dollars).
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