The U.S. Food and Drug Administration today approved Odactra, the first allergen extract to be administered under the tongue (sublingually) to treat house dust mite (HDM)-induced nasal inflammation (allergic rhinitis), with or without eye inflammation (conjunctivitis), in people 18 through 65 years of age.
Odactra is a 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.
Dust mites are gross, tiny little insects that are related to spiders. They are so small you cannot see them. They feed on shed skin cells and like to collect in fiber surfaces. This is because fibers collect skin; and skin is their food.
Dust mites are the most common household allergen. Their bodies and feces contain the proteins that cause the allergic reactions. The little allergen bits also collect in fiber surfaces, and can be difficult to remove.
Odactra exposes patients to house dust mite allergens, gradually training the immune system in order to reduce the frequency and severity of nasal and eye allergy symptoms. It is a once-daily tablet, taken year round, that rapidly dissolves after it is placed under the tongue. The first dose is taken under the supervision of a health care professional with experience in the diagnosis and treatment of allergic diseases. The patient is to be observed for at least 30 minutes for potential adverse reactions. Provided the first dose is well tolerated, patients can then take Odactra at home. It can take about eight to 14 weeks of daily dosing after initiation of Odactra for the patient to begin to experience a noticeable benefit.
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 inactiveplacebo.
The most common side effects were nausea, itching in the ears and mouth, and swelling of the lips and tongue. The prescribing information includes a boxed warning that severe allergic reactions, some of which can be life-threatening, can occur. As with other FDA-approved allergen extracts administered sublingually, patients receiving Odactra should be prescribed auto-injectable epinephrine. Odactra also has a Medication Guide for distribution to the patient.