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April 02, 2014

FDA Approves Oralair... Grass Allergy Tablet by Mouth (Instead of Allergy Shots)

Today, the FDA formally approved Oralair, the first new sublingual allergy tablet to be sold in the United States that works the same way allergy shots do... but instead is dissolved under the tongue at home instead of a shot in the arm in a medical office. Although this tablet has been available in Europe for some time, only now has sale/distribution in the United States been allowed under prescription.

Oralair is made by a French pharmaceutical company Stallergenes (Greer is US distributor partner) and treats patients aged 10-65 years who are allergic to 5 different grasses: Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass. Treatment is composed of a buildup and maintenance phase. Starting 4 months prior to the grass pollen season, a 100 IR tablet is administered under the tongue in a medical office to ensure no significant side effects. At home on day 2, two 100 IR tablets are administered. On day three and daily thereafter, a 300 IR tablet is placed under the tongue until the end of the grass pollen season. The tablets take about 1 minute to dissolve.

Although in next few weeks US physicians should be able to start prescribing Oralair, it really won't do much good for this year's grass allergies because in order for this tablet to be fully effective in the treatment of grass pollen allergies, treatment needs to actually begin in December but no later than January and continue through August. Grass pollen season begins in April/May, so for at least this year, it may be too late.

Another grass tablet will soon receive FDA approval called Grastek (aka Grazax in Europe). This tablet is made by ALK-Abello and Merck and treats patients aged 5-65 years who are allergic to only Timothy Grass. Grastek has a simpler regimen of 1 sublingual tablet daily starting 12 weeks before and continued until the end of the grass pollen season. As with Oralair, the first dose is given in a medical office to ensure safety with all other doses are taken at home. The tablet dissolves in less than 10 seconds.

For both tablets, epipen needs to be available at home due to possible risk of anaphylaxis. As with allergy shots, patients on beta-blockers for high blood pressure are not eligible to undergo this treatment.

Sources:
Stallergenes wins U.S. go-ahead for Oralair allergy pill. Reuters 4/2/14

Grastek Recommended by FDA Panel for Timothy Grass Allergy. Medscape 12/12/13
Fauquier blog
Fauquier ENT

Dr. Christopher Chang is a private practice otolaryngology, head & neck surgeon specializing in the treatment of problems related to the ear, nose, and throat. Located in Warrenton, VA about 45 minutes west of Washington DC, he also provides inhalant allergy testing/treatment, hearing tests, and dispenses hearing aids. Google+ Christopher Chang, MD Bio

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