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Odactra Drug - First Sublingual Allergen Extract for House Dust Mite Allergy Approved by FDA

Odactra Drug - First Sublingual Allergen Extract for House Dust Mite Allergy Approved by FDA

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  • Dust mites commonly present in the house can cause allergies.
  • Odactra drug is the first sublingual allergen extract approved by the United States Food and Drug Administration (USFDA) for treating house dust mite allergy.
  • The drug was found to show 16% to 18% reduction in allergy symptoms.

The United States Food and Drug Administration (USFDA) has approved the first sublingual allergen extract called Odactra to treat house dust mite allergies. Dust mites are the most common cause of allergy and asthma . House dust mites are responsible for triggering asthma symptoms like wheezing, coughing, chest tightness and shortness of breath. Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, said, "House dust mite allergic disease can negatively impact a person's quality of life."

"The approval of Odactra provides patients an alternative treatment to allergy shots to help address their symptoms."


The FDA has approved the Odactra drug along with a boxed warning in the prescribing information which states that the drug is capable of causing severe allergic reactions that may be life-threatening.

Patients who receive Odactra drug must, therefore, also be prescribed auto-injectable epinephrine.

Odactra is sublingually administered under the tongue to treat nasal inflammation (allergic rhinitis), with or without eye inflammation (conjunctivitis) induced by house dust mites in people between the age of 18 and 65 years of age.

Efficacy of Odactra Drug in Treating House Dust Mites

The safety and efficacy studies of Odactra drug were conducted on 2500 people from the United States, Canada and Europe. These patients reported symptoms of allergy and felt the need to use symptom-relieving allergy medications.

Some of the patients were given sublingual Odactra drug while others received a placebo drug (a control substance).

The findings of the study suggested that during treatment, Odactra patients showed a 16% to 18% reduction in symptoms of allergy and the need for taking additional medications when compared to patients who took a placebo.

Odactra Drug

The drug is found to expose patients to house dust mite allergens, which would train the immune system to reduce the frequency and severity of nasal and eye allergy symptoms.

Odactra drug is taken once in a day in a tablet form through the year; it dissolves rapidly when placed under the tongue.

The first dose of the drug is taken under the supervision of a health care professional who has prior experience in the diagnosis and treatment of allergic diseases.

The patient is observed for30 minutes to check for the presence of any potential adverse reactions.

If the patient can tolerate the adverse effects well, the next dose can be taken at home. It takes around eight to 14 weeks after treatment for noticeable benefits.

Commonly Reported Adverse Effects
  • Nausea
  • Itching in the ear and mouth
  • Swelling of the lips and tongue
House Dust Mite Allergy

Allergies which result due to the presence of tiny bugs in house dust are capable of causing house dust mite allergy.

These dust mites are too small to be seen under a microscope and are found in carpeting, bedding, and furniture clothing.

Common Symptoms of House dust mite allergy
  • Cough
  • Runny nose
  • Nasal itching
  • Nasal congestion
  • Sneezing
  • Itching and watery eyes
How to Prevent House Dust Mites Allergy

  • Limit the exposure to dust mites by maintaining cleanliness.
  • Use dust-proof covers to cover the pillows and mattresses.
  • Wash the rugs and carpets in hot water.
  • Avoid using curtains and upholstery made of certain fabrics that the mites usually inhabit.
  • Reduce humidity in the house by using a dehumidifier or air conditioner.

  1. FDA approves Odactra for house dust mite allergies - (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm544330.htm)
  2. Dust Mite Allergy - (http://www.aafa.org/page/dust-mite-allergy.aspx)
  3. About Dust Mite Allergy - (http://asthmaandallergies.org/asthma-allergies/dust-mite-allergy/ )

Source: Medindia

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