- The Washington Times - Tuesday, January 31, 2006

A Bethesda pharmaceutical company yesterday won Food and Drug Administration approval to sell a medication that treats chronic constipation in adults.

The FDA approved the sale of Sucampo Pharmaceuticals Inc.’s lubiprostone capsules, which are marketed as Amitiza.

Amitiza works by increasing the body’s intestinal fluid secretion, which helps ease the passage of stools and alleviate symptoms associated with chronic constipation, the FDA said.

Constipation, one of the most commonly reported digestive problems, affects more than 33 million U.S. adults, causing 2.5 million doctor visits annually, Sucampo estimated.

About 3 million Americans reported having frequent constipation, with most being women and adults 65 or older, according to the most recent data from the National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health.

“As a science-driven pharmaceutical company, Sucampo is pleased to be able to provide a new drug based on a novel mechanism of action that has the potential to help millions,” said Sucampo President and Chief Executive Officer Sachiko Kuno.

It’s the first Sucampo product that has received U.S. market approval, said company spokesman Brad Fackler.

The company was founded in 1996 as an affiliate of an international group of pharmaceutical companies known as Sucampo Group. It has two drugs in preclinical development trials.

Amitiza is expected to be on market shelves in the spring, Mr. Fackler said. He would not say how much the drug will cost.

Sucampo will make Amitiza at a Japanese plant but have it encapsulated by Cardinal Health Inc., a Dublin, Ohio, drug and medical device manufacturer, Mr. Fackler said.

Sucampo will sell the drug with Japanese drug maker Takeda Co. Ltd. in the United States and Canada. A Takeda spokesman yesterday declined to comment, citing an agreement with Sucampo.

Amitiza has been shown in two clinical studies to give 60 percent of patients a bowel movement within 24 hours of taking the medication.

Common side effects reported in testing included headache, nausea, diarrhea, abdominal pain and swelling.

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