FDA Approves Lubiprostone (Amitiza) for Women with IBS with Constipation

By Peggy Peck
ROCKVILLE, 01 may 2008-- The FDA has approved lubiprostone (Amitiza) for women 18 or older with irritable bowel syndrome with constipation (IBS-C).
Lubiprostone, already approved for chronic idiopathic constipation, becomes the only prescription drug approved for IBS-C. The FDA said the drug should be taken twice a day in 8 mcg doses with food and water.
Tegaserod (Zelnorm), the IBS-C drug pulled from the market a year ago, is no longer available under an investigational new drug protocol plan that permitted its use in symptomatic women younger than 55 in "critical need" . The program was suspended in March.
In two lubiprostone clinical trials with 1,154 IBS-C patients, 12 weeks of the agent at 8 mcg bid was associated with moderate to significant improvement in symptoms compared with placebo, the FDA said. Only 8% of the patients in the trials were men and the FDA said that efficacy was not demonstrated in men.
Common side effects of lubiprostone included nausea, diarrhea, and abdominal pain. Other rare side effects include urinary tract infections, dry mouth, syncope, peripheral edema, dyspnea, and heart palpitations.
Lubiprostone is not approved for use in children and men. It is not to be given to patients with severe diarrhea or known or suspected bowel obstructions. Its safety and efficacy has not been established in patients with renal or hepatic impairment, women who are pregnant, or nursing mothers.
Amitiza is manufactured by Sucampo Pharmaceuticals, Bethesda, Md., and Takeda Pharmaceuticals America, Inc., Deerfield, Ill.