The US Food and Drug Administration (FDA) has approved Odactra (Merck, Sharp & Dohme Corp), the first sublingual allergen extract for the treatment of house dust mite–induced allergic rhinitis, with or without conjunctivitis in adults aged 18 through 65 years.
“House dust mite allergic disease can negatively impact a person’s quality of life,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in an FDA news release. “The approval of Odactra provides patients an alternative treatment to allergy shots to help address their symptoms.”
Odactra reduces the occurrence and severity of nasal and eye allergy symptoms by desensitizing patients to house dust mite allergens. It is a tablet that is placed under the tongue, where it dissolves rapidly. Patients take Odactra once daily, year round.
Because it can cause life-threatening adverse reactions, the first dose is administered “under the supervision of a health care professional with experience in the diagnosis and treatment of allergic diseases,” the FDA explains in the news release. Patients must be observed for 30 minutes or longer for potential adverse reactions. If the patient tolerates the first dose well, they can continue taking it at home.
Patients may need to take Odactra daily for 8 to 14 weeks before they experience noticeable improvement in their symptoms.
The FDA’s decision follows consideration of data from clinical trials that involved about 2500 people in the United States, Canada, and Europe.
Patients who received Odactra reported a 16% to 18% reduction in their symptoms and the need for other symptom-relieving medications compared with patients who received a placebo.
The most frequently reported adverse events were nausea, itching in the ears and mouth, and swelling of the lips and tongue. The prescribing information includes a boxed warning that severe and sometimes life-threatening allergic reactions can occur. Clinicians should prescribe autoinjectable epinephrine to patients receiving Odactra, as with other FDA-approved sublingual allergen extracts. Odactra also comes with a medication guide to be given to the patient.