New FDA-Approved Pill Could Replace Seasonal Allergy Shots

The Food and Drug Administration approved the first sublingual (under the tongue) allergen extract aimed to treat grass pollen allergies earlier today. The allergen, Oralair, could potentially help 30 million people in the U.S. and 500 million worldwide.

The FDA released a press announcement earlier today that confirmed the approval of Oralair. The sublingual tablet is comprised of extracts from five grass pollens mixed together. They include Kentucky bluegrass, Orchard, Perennial rye, Sweet vernal, and Timothy. The pill comes in strengths of 100 instant-release (IR) and 300 instant-release.

Similar to allergy shots, the pill takes several months to start working, so those who were hoping to avoid allergy season in the coming months will have to wait. Similar to the flu vaccine, Oralair is a form of immunotherapy. The allergy sufferers will be exposed to small amounts of the substances that they suffer from in order to build immunity when taking the pill.

The Allergenic Product Advisory Committee (APAC) Meeting for Oralair took place in December of 2013, in which they finalized the FDA briefing document for the pill's Biologic License Application (BLA). In the document, the dosing regimen was specified: A three-day dose escalation phase is followed by a maintenance phase. The patient will receive one Oralair tablet of 100 IR on the first day, two tablets of 100 IR on the second day, and one 300 IR tablet on the third day. Then the maintenance phase will feature one 300 IR tablet taken daily.

Studies conducted by the FDA found that Oralair reduced symptoms as well as the reliance on allergy medication by 16% to 30%. One-third of the patients in the study reported having itchy mouths after taking the pill and some claimed to have throat irritation. And those interested in receiving the medication should know that it only treats one kind of allergy: grass pollen.

To read more about the FDA's approval of Oralair as well as its effects and dosage, visit this USA Today news article.