Amitiza (lubiprostone) is a prescription drug used to relieve abdominal pain, bloating, and straining and produce softer and more frequent bowel movements in men and women who have chronic idiopathic (functional) constipation, and to treat irritable bowel syndrome with constipation (IBS-C) in women who are at least 18 years of age. It was also FDA approved in 2013 to treat opioid-induced constipation in adult patients with chronic non-cancer pain. Amitiza works by increasing the amount of fluid that flows into the bowel and allowing the stool to pass more easily.
Lubiprostine Study Published Showing Efficacy in Opioid-Induced Constipation (OIC)
May 6, 2014 – A study published in the medical journal Pain Medicine examined the efficacy and safety of AMITIZA (lubiprostone) for relieving symptoms of opioid-induced constipation (OIC) in chronic non-cancer pain. The study found that patients treated with lubiprostone showed significant overall improvement for abdominal discomfort, straining, constipation severity and stool consistency when compared to placebo. The authors concluded that lubiprostone effectively relieved OIC and associated signs and symptoms and was well tolerated in OIC patients with chronic noncancer pain.
Swiss Prescribing Regulations for Amitiza Relaxed
February 6, 2014 – The Swiss Federal Office of Public Health has lifted several limitations on prescribing Amitiza (lubiprostone) to patients with chronic idiopathic constipation (CIC). The changes make Amitiza more widely available to patients. Patients can now be prescribed Amitiza from all physicians, not just gastroenterologists, and can be using the prescription for up to a year before a prescription review is required.
Phase 3 Studies Begin of Lubiprostone to treat Pediatric Functional Constipation
December 17, 2013 – A Phase 3 clinical trial program of lubiprostone in the treatment of pediatric functional constipation has been announced by Sucampo Pharmaceuticals and its development and commercialization partner Takeda Pharmaceuticals. This Phase 3 program was preceded by an open-label trial in 124 patients aged 3 to 17 years, which suggested that lubiprostone warrants further investigation as a potential treatment for children and adolescents with functional constipation.
This program consists of two well-controlled pivotal studies with similar design. The first Phase 3 trial in the program will study the efficacy, safety, and pharmacokinetics of lubiprostone in pediatric subjects between the ages of 6 to 17. The trial is expected to enroll more than 500 patients with pediatric functional constipation at up to 100 sites across the United States, Canada, and Europe.
The second Phase 3 trial will test lubiprostone liquid formulation in patients aged 6 months to under 6 years.
Evaluation of the long-term safety of lubiprostone in these populations through two open-label extension studies is planned. Sucampo plans to file a supplemental new drug application with the U.S. Food and Drug Administration (FDA) following program completion, which is anticipated by early 2016.
Lubiprostone increases intestinal fluid secretion, softens stools, and increases motility in the intestine, thereby facilitating the passage of stool and alleviating symptoms associated with chronic idiopathic constipation.
Clinical Trial of Lubiprostone Liquid Formulation
(October 23, 2013) The makers of Amitiza have announced a randomized, placebo-controlled, double-blinded, multi-center study of a liquid form of lubiprostone in adult subjects with chronic idiopathic constipation (CIC). The trial is expected to enroll 152 patients with CIC at approximately 11 sites in the United States. A liquid formulation could possibly offer an alternative dosing option for a wider range of patients.
FDA Approves Label Change for Amitiza
(November 30, 2012) The FDA approved a Prescribing Label change for Amitiza that removed all pregnancy-related warnings and precautions. Nursing mothers who are taking Amitiza are advised to monitor their infants for diarrhea.
Amitiza Study Looks at Long-Term Safety
(March 7, 2012) A study of lubiprostone (Amitiza) looked at the long-term safety, tolerability, and patient outcomes in people with irritable bowel syndrome with constipation (IBS-C).
The researchers concluded that in patients with IBS-C, lubiprostone 8 mcg twice daily was found to be safe and well tolerated over 9–13 months of treatment. The study provides preliminary evidence for the safety of lubiprostone in the long-term treatment of IBS-C.
The extension study enrolled 520 IBS-C patients who had completed one of two randomized phase 3 studies. All enrolled patients received open-label lubiprostone orally for 36-weeks (8 mcg, twice daily).
Significant improvements from baseline were reported, with initial improvements maintained throughout the study.
The overall safety profile of lubiprostone during this study was similar to that observed in the preceding phase 3 studies. The most common side effects were diarrhea and nausea (11.0% each), urinary tract infection and sinusitis (9.0% each) and abdominal distention (5.8%). Seventeen patients discontinued due to a treatment-related side effects. No serious side effects were considered treatment-related.
The study was reported in the journal Alimentary Pharmacology & Therapeutics. This study was funded in part by Sucampo Pharma Americas, Inc., Bethesda, MD and in part by Takeda Pharmaceuticals USA, Deerfield, IL.
Lubiprostone Dose-Dependent Improvement of Constipation
(February 14, 2011) A 2-week study in Japan, reported in the journal Neurogastroenterology & Motility, looked at lubiprostone (Amitiza® in the U.S.) for the treatment of chronic functional constipation in 170 patients with or without irritable bowel syndrome (IBS). The results suggest that lubiprostone produced a steady and effective improvement in the symptoms of constipation with or without IBS in a dose-dependent manner with a good safety profile and tolerability in a Japanese population. The study also suggests the optimal dose and usage of lubiprostone to improve spontaneous bowel movement in constipated patients regardless of ethnicity.
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 to treat IBS. 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 USA, Deerfield, IL.