The Food and Drug Administration (FDA) has approved Odactra (Merck) sublingual tablets for the treatment of house dust mite (HDM)-induced allergic rhinitis with or without conjunctivitis in patients aged 18–65 years. Odactra is the first sublingual allergen extract to be approved for this condition.

Odactra works by exposing the patient’s immune system to house dust mite allergens in a gradual manner to decrease the frequency and severity of nasal and eye allergy symptoms. The first dose of Odactra is given under the supervision of a healthcare professional and the patient should be observed for at least 30 minutes for possible adverse reactions. If the first dose is well tolerated, patients can then take Odactra at home. It may take 8–14 weeks of treatment for the patient to experience a clear benefit.

The safety and efficacy of Odactra were evaluated in clinical studies that included approximately 2,500 patients. Study patients received Odactra or placebo and were evaluated on their symptoms and need for additional symptom-relieving allergy medications. The data showed patients who took Odactra had a 16–18% reduction in symptoms and the need for additional medications vs. patients who took placebo.

Odactra carries a Boxed Warning stating that severe allergic reactions can occur, which may be life-threatening. Patients prescribed Odactra should also be prescribed an auto-injectable epinephrine.

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“House dust mite allergic disease can negatively impact a person’s quality of life,” said Peter Marks, M.D., Ph.D., 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.”

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