TPNA - Amitiza

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amitiza

Takeda entered into a new therapeutic area of gastrointestinal disorders in January 2006, when the U.S. Food and Drug Administration approved AMITIZA™ (lubiprostone), 24-mcg soft-gel capsules, for the treatment of chronic idiopathic constipation in adults.

AMITIZA (pronounced ahm-i-TEE-za) is the first selective chloride channel activator approved for therapeutic use in chronic idiopathic constipation, a condition that affects both men and women and affects patients over the age of 65 more frequently. Idiopathic means the cause of the constipation is not known and not due to an underlying illness or medication.

It works by increasing fluid secretion locally in the small intestine by activating the ClC-2 chloride channel, and thereby increasing the passage of the stool and improving symptoms associated with chronic idiopathic constipation. In clinical trials up to 60 percent of patients who used AMITIZA experienced a spontaneous bowel movement within the first 24 hours of starting treatment.

AMITIZA improved signs and symptoms related to chronic idiopathic constipation, including abdominal bloating, discomfort, stool consistency and straining. Additionally, these symptomatic improvements lasted over the six to 12 month treatment period.

AMITIZA is developed by Sucampo Pharmaceuticals, Inc., and will be jointly marketed in the United States by Sucampo Pharmaceuticals, Inc., and Takeda Pharmaceuticals North America, Inc. The AMITIZA sales force in the United States will comprise representatives from both companies.

AMITIZA should not be used in patients with a known hypersensitivity to any components of the formulation and in patients with a history of mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be evaluated prior to initiating AMITIZA treatment.

The safety of AMITIZA in pregnancy has not been evaluated in humans. In guinea pigs, lubiprostone has been shown to have the potential to cause fetal loss. AMITIZA should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with AMITIZA and should be capable of complying with effective contraceptive measures.

AMITIZA should not be administered to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment. If the diarrhea becomes severe, patients should consult their health professional.

In clinical trials, the most common adverse event was nausea (31%). Other adverse events (=5% of patients) included diarrhea (13%), headache (13%), abdominal distention (7%), abdominal pain (7%), flatulence (6%), sinusitis (5%) and vomiting (5%).

For complete prescribing information, please visit http://www.amitiza.com.

Clinical trials are research studies conducted on new drugs or treatments in the pharmaceutical industry to test if they are safe and effective for patients. A clinical trial seeks to answer questions and find solutions to provide patients the safest, best treatment for a disease or illness.

Clinical trials depend on people who volunteer to try a new drug or treatment. In some cases, a drug has not yet been approved by the Food and Drug Administration (FDA) to be sold in the United States. Or, the drug has been approved, but it is being tested for a different treatment or additional information.

There are four different "phases" of clinical development:

Phase 1: This type of trial involves a small group of people (20-80), and it is the first time a drug is tested in people. Researchers study whether the drug is safe and identify side effects and safe dosage amounts. This phase usually includes healthy volunteer subjects.
Phase 2: This type of trial involves more people (100-300) than a Phase I trial, and it is typically is the first time the drug is tested in a patient population for which the drug is being developed. The primary purpose for this type of trial is to assess the drug’s effectiveness in the patient population for which it is intended. Researchers continue to study the drug’s safety
Phase 3: During this phase of clinical development, trials usually involve a large group of people (1,000-3,000). Researchers evaluate how the patients are reacting to the drug – evaluating whether the drug is helping treat the patient as it should, monitoring additional side effects, comparing it to commonly used treatments and continuing to study ways for the drug to be used safely
Phase 4: Commonly called post-marketing studies, this type of trial continues to focus on the drug’s safety, effectiveness and the best way the drug should be used.

For more information please view:

Glossary of Clinical Trials
Clinical Trials Frequently Asked Questions