The US Food and Drug Administration (FDA) has approved Odactra, a once-daily sublingual tablet, for the treatment of house dust mite-induced nasal inflammation, with or without eye inflammation,in adults aged 18 to 65 years. Odactra is the first allergen extract to be administered under the tongue for the treatment of house dust mite allergies. Odactra is a once-daily tablet that rapidly dissolves after it is placed under the tongue, and is intended to be taken year-round. The tablet exposes patients to dust mite allergens and gradually trains the immune system to reduce the frequency and severity of nasal and eye allergy symptoms.
After taking the first dose of Odactra, patients should be observed for 30 minutes for potential adverse events by a health care professional with experience in the diagnosis and treatment of allergic diseases. If the patient does not experience adverse reactions, then Odactra can be taken at home. It can take 8 to 14 weeks before a patient may begin to experience any noticeable benefits taking Odactra.
As with other FDA-approved sublingual allergen extracts, Odactra should be prescribed with auto-injectable epinephrine. The safety and efficacy of Odactra was evaluated in studies involving approximately 2500 individuals from Europe, Canada, and the United States. Participants were assigned to receive either placebo or Odactra, and reported their symptoms and need for symptom-relieving allergy medications.Compared with the placebo, participants taking Odactra experienced a 16% to 18% reduction in allergy symptoms and the need for additional medications.
The most common adverse events were nausea, itching in the ears and mouth, and swelling of the lips and tongue.
FDA approves Odactra for house dust mite allergies [press release]. FDA. March 1, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm544330.htm?source=govdelivery&utm_