(dailyRx News) Intestinal diseases and surgery can cause nutritional problems. A new drug has been approved to help combat these problems.
The US Food and Drug Administration has approved Gattex (teduglutide) to treat a condition known as short bowel syndrome in adults. The medication helps patients gain additional nutrition from intravenous (IV) feeding.
Short bowel syndrome (SBS) is caused by the surgical removal of part or all of the small and/or large intestine. Diseases, such as colon cancer or Crohn's disease, injury or trauma can also cause this condition which interferes with the body’s ability to absorb fluids and nutrients. IV feeding – what’s known as parenteral nutrition – is often given to SBS patients
An injection that’s given once a day, Gattex helps to improve intestinal absorption of fluids and nutrients, which reduces the need for parenteral nutrion.
Two other drugs are also available to treat SBS. Zorbtive (somatropin) was approved in 2003 and Nutrestore (glutamine) in 2004.
“Today’s approval expands the available treatment options for patients with this life-threatening condition,” said Victoria Kusiak, MD, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research in a statement. Because Gattex may cause other serious health conditions, it is critical that patients and healthcare professionals understand the drug’s potential and known safety risks.”
The medication has some potentially dangerous side effects, including an increased risk of developing cancer. Patients taking Gattex also have higher risks of having abnormal growths called polyps and obstructions in the intestine. Gallbladder, biliary tract and pancreatic disease risks are also higher in these patients.
As a result, Gattex is being approved with what’s called a Risk Evaluation and Mitigation Strategy. This requires the manufacturer to develop a communication plan and training for prescribers.
The approval is based on two clinical trials and two extension studies measuring clinical response, defined as reducing the need for parenteral nutrition after 20 and 24 weeks of treatment. At 20 weeks, 46 percent of Gattex treated patients achieved a clinical response, compared to 6 percent of people on placebo. After 24 weeks, those number jumped to 63 percent among the Gattex group and 30 percent of patients who received a placebo.
The most common side effects of Gattex were abdominal pain, injection site reactions, nausea, headaches, abdominal distension and upper respiratory tract infection.
The post-market study the FDA is requiring will look at the increased risk of colorectal cancer and other conditions. Patients in this study will be followed for at least 10 years.
The pricing for Gattex has not yet been established. A single 8.8 mg vial of its competitor Zorbtive runs about $850. Dosages for that drug can range from 0.1 mg/kg to 8 mg per day. A 30-day supply of Nutrestore powder is roughly $110.
The new medication will be available in the first quarter of 2013.
Gattex is marketed by NPS Pharmaceuticals. Zorbtive is marketed by EMD Serono, and Nutrestore is marketed by Emmaus Medical Inc.