FDA Approves Odactra - New Treatment for Dust Mite Allergies
THURSDAY, March 2, 2017 -- A new treatment for dust mite allergies has won approval from the U.S. Food and Drug Administration.
Odactra is a year-round, once-a-day tablet that's dissolved under the tongue. It's approved for use in people aged 18 to 65.
"House dust mite allergic disease can negatively impact a person's quality of life," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
"The approval of Odactra provides patients an alternative treatment to allergy shots to help address their symptoms," he added in an agency news release.
House dust mites are tiny bugs found in such places as bedding, upholstered furniture and carpets. Symptoms of dust mite allergies include a cough, sneezing, runny nose and congestion, as well as itchy and watery eyes.
Odactra exposes patients to dust mite allergens in order to retrain the immune system, and reduce the frequency and severity of allergy symptoms. Patients should begin to see the benefit within eight to 14 weeks, according to the FDA.
In clinical trials, people who took Odactra had a 16 percent to 18 percent reduction in allergy symptoms requiring use of other medicine, compared to those who took an inactive placebo.
The most common side effects were nausea, itching in the ears and mouth, and swelling of the lips and tongue. Odactra carries a boxed warning stating that severe, and potentially life-threatening, allergic reactions can occur.
The American Lung Association has more on dust mites.
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Posted: March 2017