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Low Dose Visicol Is Highly Effective in Treatment of Chronic Constipation

BLUE BELL, Pa.--(BUSINESS WIRE)--April 19, 2004--InKine Pharmaceutical Company, Inc. (Nasdaq:INKP) today announced the successful completion of a Phase IV study of Visicol(R) tablets in patients with functional constipation or constipation predominant Irritable Bowel Syndrome. The study demonstrated nearly 100% effectiveness in increasing the number of bowel movements per week while significantly reducing the associated symptoms of constipation.

"The results of this study are consistent with what some physicians have already observed in clinical practice," said Seymour Katz, M.D., FACP, MACG, Clinical Professor of Medicine, New York University School of Medicine, who is a study investigator at Long Island Clinical Research Associates, in Great Neck, NY. "The success rate and rapid response of constipated patients to Visicol(R) are very encouraging and support further study," added Dr. Katz.

The multicenter study included 40 evaluable patients with chronic constipation, which was defined as three or less bowel movements per week. The patients were randomized to receive daily either a single four tablet dose or an eight tablet regimen, with four tablets dosed twice over 15 minutes. Eight ounces of fluid was given with each dose and the dose could be adjusted based on response at pre-determined time intervals. The treatment period was four weeks with weekly assessments.

The results of the study are as follows:

Four Tablet Dose:
The median time to first bowel movement in the four tablet group was 21 hours and by the end of week one the four tablet group averaged seven bowel movements per week. By the end of week four, the four tablet group averaged nine bowel movements per week. These changes were highly statistically significant. All patients responded to therapy (by meeting defined criteria regarding an increase in the number of bowel movements) during their last week of treatment, with 88% responding in the first week. Additionally, there was a highly statistically significant improvement in constipation-associated symptoms such as straining, cramping, bloating, rectal irritation and stool consistency when compared to baseline. In the four-tablet group there were no withdrawals due to adverse events and there were no statistically significant changes in mean blood electrolyte levels after four weeks of therapy.

Eight Tablet Dose:
The median time to first bowel movement in the eight-tablet group was four hours and by the end of week one the eight tablet group averaged ten bowel movements per week. By the end of week four, the eight tablet group averaged nine bowel movements per week. While these changes from baseline were highly statistically significant, the average change in bowel movements per week were not statistically different between the two treatment arms at any time following the end of the first treatment week. Ninety-two percent of patients responded to therapy (by meeting defined criteria regarding an increase in the number of bowel movements) during their last week of treatment, with 88% responding in the first week. There were statistically significant improvements in constipation-associated symptoms such as straining, cramping, bloating, and stool consistency when compared to baseline. Four patients withdrew from the study because of non-serious adverse events. There was a modest, but statistically significant, decrease in serum potassium at the end of the study compared to baseline consistent with the substantial increase in the number of bowel movements in the eight tablet group.

Seven of the patients in the study suffered from constipation predominant Irritable Bowel Syndrome, a particularly difficult type of chronic constipation to treat. All seven patients, four of whom were in the four tablet group, responded successfully to Visicol(R) therapy.

"These outstanding results show that the lowest dose of Visicol(R) studied was well tolerated and produced a rapid and sustained laxative effect in patients with chronic constipation. Straining, cramping, bloating, rectal irritation, and stool consistency were greatly improved in these chronically constipated patients. The results in patients suffering from constipation predominant Irritable Bowel Syndrome were particularly promising," said Martin Rose, M.D., J.D., InKine's Executive Vice President for Research and Development. "Based on these results, we intend to use doses in the range of two to four tablets in future fixed-dose controlled studies," added Dr. Rose.

"We are highly encouraged by the results of the study. The rapidity and magnitude of the response to low dose Visicol(R) in constipated patients compare favorably with the results of studies with the leading prescription laxatives, Miralax(R) and Zelnorm(R)," said Leonard S. Jacob, M.D., Ph.D., Chairman and Chief Executuve Officer of InKine. "We intend to pursue a constipation indication for Visicol(R), which if approved, should add significantly to the revenues from this product," added Dr. Jacob.

Source: InKine Pharmaceutical Company, Inc.

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