AMITIZA

News from Takeda Pharmaceuticals North America, Inc. and Sucampo Pharmaceuticals, Inc.

FDA Approves Amitiza for Treatment of IBS

BETHESDA, MD--(FDA News - April 29, 2008) - The U.S. Food and Drug Administration today approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over. There is currently no prescription drug therapy for IBS-C. With this approval, Amitiza becomes the only FDA-approved medical treatment for IBS-C available in the United States.

Irritable bowel syndrome is a disorder characterized by cramping, abdominal pain, bloating, constipation, and diarrhea. IBS causes a great deal of discomfort and distress to its sufferers. It affects at least twice as many women as men.  

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

The safety and efficacy of Amitiza was established in two major studies involving 1,154 patients diagnosed with IBS-C. The majority of the patients studied were women (approximately 8 percent were men). Patients enrolled in the studies were experiencing at least mild abdominal discomfort or pain that was associated with at least two 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 Amitiza and others were given a placebo. More patients treated with Amitiza reported that their IBS symptoms were moderately or significantly relieved over a 12 week treatment period than patients who received placebo. The safety of long term treatment was assessed in a study in which all patients were treated with Amitiza for a duration that ranged 9 to 13 months.

The efficacy of Amitiza in men was not conclusively demonstrated for IBS-C.
Amitiza, like most prescription medications, is accompanied by some side effects. Common side effects of Amitiza include nausea, diarrhea, and abdominal pain. Other rare side effects include urinary tract infections, dry mouth, syncope (fainting), peripheral edema (swelling of the extremities), dyspnea (difficulty breathing), and heart palpitations.

Amitiza should be taken twice-a-day in 8 microgram doses with food and water. Patients and their health care professionals should periodically assess the need for continued therapy.

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

Amitiza is also approved for the treatment of chronic idiopathic constipation (CIC), but the dose for that indication is higher, 24 micrograms twice a day.

Amitiza is manufactured by Sucampo Pharmaceuticals, Bethesda, MD, and Takeda Pharmaceuticals America, Inc., Deerfield, IL.  As with all FDA-approved products, the agency will monitor Amitiza throughout its life cycle. Consumers and health care professionals are encouraged to report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.

FDA Approves Amitiza for Adults for Treatment of Chronic Idiopathic Constipation 

BETHESDA, MD--(FDA News - January 31, 2006) - The FDA today approved Amitiza (lubiprostone), the first drug of its chemical type, for the treatment of chronic constipation in the adult population where there is no known cause for the condition. The product will be available as capsules for use by adults to treat idiopathic constipation cases not caused by other diseases or by use of medications.

Chronic idiopathic constipation is generally defined as infrequent and difficult passage of stool and is one of the most common disorders suffered by Americans. This condition affects women more often than men and also affects older patients after the age of 65 more frequently. Symptoms of chronic idiopathic constipation are abdominal pain and discomfort, bloating, straining, and hard stools.

Amitiza works by increasing the intestinal fluid secretion, which helps ease the passage of stool and helps alleviate symptoms associated with chronic idiopathic constipation. FDA based its decision to approve Amitiza on the results from two clinical trials, which were conducted in patients with, on average, less than 3 spontaneous bowel movements per week with symptoms of constipation for at least 6 months prior to entry into the studies. The studies demonstrated that subjects treated with Amitiza had a higher frequency of bowel movements in the first week than the placebo subjects. In both studies, results similar to those in Week 1 were also observed in Weeks 2, 3, and 4 of therapy. In addition, three long-term studies showed that Amitiza decreased constipation severity, abdominal bloating and discomfort over 6-12 months of use.

The most common adverse events reported in the trials included headache, nausea, diarrhea, abdominal pain, and distension. Whether these events are related to the drug is not known at present.

Amitiza should be taken twice a day with food. Physicians and patients should periodically assess the need for continued treatment.

Amitiza is marketed by Sucampo Pharmaceuticals, Inc., Bethesda, MD., and by Takeda Pharmaceuticals America, Lincolnshire, IL.