New top-line results for patient preference study evaluating Kristalose for Oral Solution announced

Cumberland Pharmaceuticals Inc. (CPIX) today announced new top-line results for a patient preference study evaluating Kristalose (lactulose) for Oral Solution, a prescription laxative packaged as a crystalline powder, compared to similar products in liquid forms.

Kristalose is the only prescription-strength laxative available in pre-measured powder packets. Over a 14-day period, 50 patients with a recent diagnosis of chronic constipation were administered both Kristalose and liquid lactulose in a crossover study. Patient preference was measured through survey responses collected at the end of the study.

"Patients think that Kristalose tastes better and is more convenient than other options, which means that they are more likely to take the medication as directed," notes one investigator for the study, Charles F. Barish, MD, President of Wake Research Associates in Raleigh, North Carolina and Clinical Assistant Professor of Medicine at the University of North Carolina School of Medicine. "It makes sense to prescribe medications that encourage patient compliance with the treatment protocol."

Overall, more patients preferred Kristalose, noting portability as a key differentiating feature, as Kristalose is distributed in pre-measured packets. More patients also preferred the taste of Kristalose as well as the consistency compared to the syrup formulations.

"We have believed for some time that patients prefer taking Kristalose over other alternatives in liquid and syrup forms," said A.J. Kazimi, Chief Executive Officer at Cumberland Pharmaceuticals. "This study also offers data demonstrating the importance of convenience for these patients, which Kristalose can provide."

There was no significant difference in adverse effects between patients who took Kristalose and those taking liquid lactulose.

Background

Kristalose (lactulose) for Oral Solution is a proprietary prescription laxative and the brand name for a 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.

This multicenter, randomized, open label, crossover trial was conducted over 14 days. As with previous clinical trials, Cumberland Pharmaceuticals plans to submit the results of this study for publication.

According to the National Digestive Diseases Information Clearinghouse (NDDIC), constipation is one of the most common gastrointestinal complaints in the United States. More than 4 million Americans have frequent constipation, accounting for 2.5 million physician visits a year.