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Kristalose(R) Offers Prescription Alternative to MiraLAX(R) and Other PEG 3350 Products
Date:2/26/2008

Unique, crystalline laxative designed to enhance patient acceptance and

compliance

NASHVILLE, Tenn., Feb. 26 /PRNewswire/ -- Kristalose(R), a prescription laxative product that treats acute and chronic constipation, may be an effective option for physicians and pharmacists looking for a prescription alternative to MiraLAX(R) and generic PEG 3350 products. Marketed in the U.S. by Cumberland Pharmaceuticals, Kristalose(R) is now the only prescription- strength laxative available in a convenient powder packet.

(Photo: http://www.newscom.com/cgi-bin/prnh/20080226/CLTU122 )

Previously available by prescription, MiraLAX(R) (polyethylene glycol 3350 or PEG 3350) became an over-the-counter (OTC) treatment for occasional constipation in early 2007. Due to U.S. Food and Drug Administration policy which does not allow the same formulation of a product to be marketed simultaneously as both a prescription and OTC drug, generic PEG 3350 products are now also becoming unavailable by prescription.(1) These generic products will not be available on the OTC market for at least three years following the MiraLAX(R) introduction due to marketing exclusivity granted by the FDA.

Physicians wrote more than 9 million prescriptions for MiraLAX(R) and generic PEG 3350 products in 2006 for treatment of constipation. As the PEG 3350 products are becoming unavailable by prescription, Cumberland believes Kristalose(R) offers a safe, effective alternative for physicians looking to retain prescriptive control for their patients.

Kristalose(R) (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. Available in pre-dosed packets, the drug dissolves quickly in four ounces of water, offering patients a virtually tasteless and grit-
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SOURCE Cumberland Pharmaceuticals Inc.
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