Kristalose(R) Preferred By Patients With Chronic Constipation Compared To Similar Products In A Recent Study

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 17 Dec 2009 - 0:00 PDT


Cumberland Pharmaceuticals Inc. ( CPIX) 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.(1)

About Cumberland Pharmaceuticals

Cumberland Pharmaceuticals Inc. is a Tennessee-based specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription products. The Company's primary target markets include hospital acute care and gastroenterology. Cumberland's product portfolio includes Acetadote® (acetylcysteine) Injection for the treatment of acetaminophen poisoning and Kristalose® (lactulose) for Oral Solution, a prescription laxative. The Company also recently launched Caldolor® (ibuprofen) Injection, the first injectable treatment for pain and fever available in the United States. Cumberland is dedicated to providing innovative products which improve quality of care for patients. The Company completed the initial public offering of its common stock in August 2009.

About Kristalose

Kristalose® (lactulose) for Oral Solution is indicated for the treatment of acute and chronic constipation. It is a unique, proprietary, crystalline form of lactulose, with no restrictions on length of therapy or patient age. Initial dosing may produce flatulence and intestinal cramps, which are usually transient. Excessive dosage can lead to diarrhea with potential complications such as loss of fluids, hypokalemia and hypernatremia. Nausea and vomiting have been reported. Use with caution in diabetics. Kristalose is contraindicated in patients who require a low-galactose diet. Elderly, debilitated patients who receive lactulose for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically.

References

(1) The National Digestive Diseases Information Clearinghouse (NDDIC)

Source: Cumberland Pharmaceuticals

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