Patients with chronic constipation prefer Kristalose oral solution

Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) today announced the publication of a patient preference study evaluating Kristalose® (lactulose) for Oral Solution, a prescription laxative packaged as a crystalline powder, compared to liquid lactulose products. The study, which appeared in the Volume 3, 2010 issue of Clinical and Experimental Gastroenterology, showed that patients with chronic constipation preferred the taste, consistency and portability of Kristalose over similar products in liquid forms.

Chronic constipation affects an estimated 15 percent of the North American population(1) and can result in serious discomfort, decreased quality of life and hospitalization.(2) Research shows that lactulose, which is available in both a powder and liquid formulation, is an effective treatment that consistently relieves constipation.(3)

"This preference for Kristalose over liquid syrups due to taste as well as the convenience of pre-measured powder packets could translate into patients being more likely to take their constipation medication as directed," said Charles F. Barish, M.D., lead author of the publication, President of Wake Research Associates in Raleigh, North Carolina, and Clinical Assistant Professor of Medicine at the University of North Carolina School of Medicine. "Patient preference often correlates with enhanced compliance, which can affect clinical outcomes."

The prospective, randomized, open-label, multicenter study evaluated 50 adult patients with a recent diagnosis of chronic constipation to measure overall preference between powder and liquid lactulose as well as preference in terms of taste, consistency and portability. The two-week study also measured the occurrence of adverse events. Patients were randomized to receive powder or liquid lactulose for seven days. The patients then crossed over to the alternative treatment for the following seven days. Doses of both formulations were determined by the patient's treating physician and patient preference was assessed by questionnaire.

More than six times as many patients preferred the portability of powder compared with liquid lactulose. Of patients expressing a preference, 44% and 57% more patients preferred the taste and consistency, respectively, of Kristalose over liquid lactulose. Overall, 77% more patients preferred Kristalose over liquid lactulose. There was no significant difference in adverse events between patients who took Kristalose and those taking liquid lactulose.  

"These findings affirm our long-held belief that the unique packaging of Kristalose in pre-dosed powder packets offers distinct benefits to patients, which can enhance ease-of-use and, ultimately, influence outcomes," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "We are pleased to offer a product that is not only safe and effective, but also offers advantages in the areas of taste, consistency and portability."

Kristalose is a proprietary prescription laxative and unique crystalline form of lactulose that treats acute and chronic constipation. The drug dissolves quickly in four ounces of water, offering patients a virtually tasteless and grit-free alternative to other liquid lactulose treatments. There are no age limitations or length of use restrictions for Kristalose, and it is the only osmotic prescription laxative still sampled to physicians.

The study, entitled "Comparison of preference and safety of powder and liquid lactulose in adult patients with chronic constipation," can be found online at http://www.dovepress.com/comparison-of-preference-and-safety-of-powder-and-liquid-lactulose-in--peer-reviewed-article-CEG.