ODACTRA FIRST SUBLINGUAL THERAPY OK’D FOR HOUSE DUST MITE ALLERGY

FCAAIA Notes: Sublingual immunotherapy (SLIT) tablets are already FDA approved for grass and ragweed. Personally, I have not found that they have a great role in the care of patients here in southwestern Connecticut. There are few patients so allergic to only those allergens that they require immunotherapy. If patients are on injections (subcutaneous allergen immunotherapy, SCIT) for multiple allergens, grass and ragweed are included if indicated. The tablets are very expensive and often not covered by insurance.

However, there are more patients allergic only to dust mites who are bad enough that immunotherapy is indicated.  SLIT tablets are an alternative for those patients when they reach the market.

A great weakness in the study and marketing of new products is that they are usually not compared to existing products in head-to-head studies.  SCIT has been proven effective (and more effective than pharmacotherapy) for numerous (but not all) aeroallergens. SLIT tablet doses are not easily compared to SCIT doses, but data indicate that significantly higher monthly doses of SLIT than SCIT are necessary for efficacy. Many practitioners offer SLIT to numerous allergens in the form of drops. Unfortunately, those preparations are not studied or shown more effective than placebo, are not FDA approved, and also are not covered by insurance. When numerous allergens are put in one vial and a few drops per day are dispensed, doses tend to be lower than with SCIT.

My conclusion at this point is that if a patient is so allergic only to grass or ragweed (and soon dust mites) that he requires immunotherapy, tablets are an option depending on cost and other factors.  However, the more daily tablets that are required for treatment, the less likely there will be adherence to the treatment.  These are issues patients should discuss with their allergists.

(Source: http://www.medscape.com/viewarticle/876513?nlid=113161_3901&src=wnl_newsalrt_170301_MSCPEDIT&uac=112079PK&impID=1300180&faf=1 March 1, 2017. For Medscape articles: User name: FCAAIA, Password: Allergies)

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.”

House dust mites are microscopic bugs that are typically found in house dust and live in bedding, upholstered furniture, and carpeting. They are close relatives of ticks and spiders. Those with allergies to house dust mites may suffer from a cough, sneezing, nasal congestion, nasal itching, and itchy, watery eyes.

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.

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