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Sucampo Granted Marketing Authorization From FDA (NASDAQ:SCMP)

By Jyotsna Ramani on 11/20/2009 – 6:50 am PSTLeave a Comment

Sucampo Pharma Europe Ltd, a subsidiary of Sucampo Pharmaceuticals Inc (NASDAQ:SCMP) has announced that Swissmedic has granted a marketing authorization for Amitiza 24 mcg gel capsules for the long term treatment of patients with chronic idiopathic constipation (CIC).

This decision by Swissmedic marks an important milestone in Sucampo’s global development and commercialization plan of lubiprostone for CIC, IBS-C and other indications. Amitiza is a local activator of type-2 chloride channels in cells lining the small intestine. It increases fluid secretion into the intestinal tract which softens the stool, facilitating intestinal motility and bowel movements. The type 2 chloride channels also play an important role in the restoration of tight junction complexes and in the recovery of barrier function in the body.

This marketing authorization is the first European regulatory approval for Sucampo and Amitiza is the first prescription medicine to be approved in Switzerland for the long-term treatment of CIC. Amitiza is already approved by the U.S. Food and Drug Administration (FDA) for the long-term treatment of CIC in adults and for the treatment of irritable bowel syndrome with constipation (IBS-C) in adult women. Amitiza is the only prescription medicine approved by the FDA for either of these indications.

The marketing authorization was based upon an assessment of safety and efficacy data obtained from a comprehensive clinical development program, including results of two randomized pivotal phase 3 clinical trials in adult CIC patients conducted in the United States. Sucampo will now work on the pricing and other distribution alternatives.

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