Tags: fda | allergy | pill | ok | oralair

FDA Allergy Pill OK: Oralair To Replace Seasonal Shots

Thursday, 03 Apr 2014 06:52 AM

By Nick Sanchez

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The FDA has approved the first allergy pill to replace the powerful shots millions receive multiple times a year to cure their grass allergies and hay fever. The pill, Oralair, is approved for patients 10 to 65, and has been sold in Europe since 2008.

The Boston Globe reports that those taking Oralair in clinical trials had a 16 to 30 percent reduction in allergy symptoms compared to those given a placebo. The FDA confirmed this finding in reviewing the trials, which tested roughly 2,500 patients. France-based Stallergenes, the manufacturer of the drug, did not comment on the pill's effectiveness compared to allergy injections.

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Similar to the shots, the pill regimen should be started four months prior to allergy season, which arrives with the blooming of grass pollen. The pill itself dissolves under the tongue, and contains extracts from five common grass types: Kentucky bluegrass, orchard, perennial rye, sweet vernal, and Timothy. By comparison, typical allergy shots contain extracts from grass pollens, tree pollen, ragweed, dust, and animal dander.

The first dose of the allergy pill must be taken under doctor supervision to determine any initial allergic reactions to the pill itself. Subsequent doses can be taken at home.

The most common side effects in adults were itchy ears, mouth and tongue. The drug also contains a warning about potentially fatal anaphylaxis.

Greer Laboratories, Stallergenes' U.S. partner, predicts the market for the drug encompasses 3 million customers, and could eventually net $1 billion in annual sales, Reuters reports. Greer plans to start selling Oralair in just weeks, however for many patients it will be too late in the season for the treatment to be fully effective.

The FDA approval triggers a payment of $10 million from Greer to Stallergenes. The milestone payment is the first of what could eventually total $120 million.

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