FDA Approves Lubiprostone as First Drug Treatment for IBS With Constipation

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Title: FDA Approves Lubiprostone as First Drug Treatment for IBS With Constipation
URL: http://www.pslgroup.com/dg/2206E2.htm
Doctor's Guide
April 30, 2008

ROCKVILLE, Md -- April 30, 2008 -- The US Food and Drug Administration has approved lubiprostone (Amitiza) for the treatment of irritable bowel syndrome with constipation (IBS-C) in adult women aged 18 years and older. There is currently no prescription drug therapy for IBS-C. With this approval, lubiprostone becomes the only FDA-approved medical treatment for IBS-C available in the United States.

"For some people, IBS can be quite disabling, making it difficult for them to fully participate in everyday activities," said Julie Beitz, MD, Director, Office of Drug Evaluation III, Center for Drug Evaluation and Research, FDA, Rockville, Maryland. "This drug represents an important step in helping to provide medical relief from their symptoms."

The safety and efficacy of lubiprostone were established in 2 major studies involving 1,154 patients diagnosed with IBS-C. The majority of the patients studied were women (approximately 8% were men). Patients enrolled in the studies were experiencing at least mild abdominal discomfort or pain that was associated with at least 2 of the following additional symptoms: (1) fewer than 3 spontaneous bowel movements per week that did not result from laxative use; (2) hard stools; or (3) moderate or severe straining with bowel movements.

In the studies, some patients received lubiprostone and others were given a placebo. More patients treated with lubiprostone reported that their IBS symptoms were moderately or significantly relieved over a 12-week treatment period compared with patients who received placebo.

The safety of long-term treatment was assessed in a study in which all patients were treated with lubiprostone for a duration that ranged from 9 to 13 months.

Lubiprostone, like most prescription medications, is accompanied by some side effects. Common side effects include nausea, diarrhoea, and abdominal pain. Other rare side effects include urinary tract infections, dry mouth, syncope, peripheral oedema, dyspnea, and heart palpitations.

The efficacy of lubiprostone in men was not conclusively demonstrated for IBS-C.

Lubiprostone should be taken twice-a-day in 8-mcg doses with food and water. Patients and their healthcare professionals should periodically assess the need for continued therapy.

Lubiprostone is not approved for use in children and men. It is not to be administered to patients suffering from severe diarrhoea or patients with known or suspected bowel obstructions. Its safety and efficacy have not been established in patients with renal or hepatic impairment, in pregnant women, or in nursing mothers.

Lubiprostone is also approved for the treatment of chronic idiopathic constipation, but the dose for that indication is higher, 24 mcg twice a day.

Lubiprostone is manufactured by Sucampo Pharmaceuticals, Bethesda, Maryland, and will be jointly marketed by Sucampo and Takeda Pharmaceuticals America, Inc., Deerfield, Illinois.

SOURCE: US Food and Drug Administration

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