New Rx Approved for Grass Pollen Allergies

Grass pollen allergy medication Oralair for use under the tongue approved by FDA

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) Some allergy patients might be able to spend this spring a little more comfortable than usual. A new form of allergy medicine was recently approved in the US.

The new medication, called Oralair, is taken under the tongue for certain grass pollen allergies and is the first of its kind approved in the US.

Health officials stressed that the medication should be first taken under a health professional's supervision.

"Talk to an allergist about ways to manage your allergies."

The US Food and Drug Administration (FDA) announced on April 2 the approval of Oralair for use by people between the ages of 10 and 65 years old to treat allergies to certain grass pollens.

Oralair, which is manufactured by French pharmaceutical company Stallergenes S.A., is an allergen extract medication that contains extracts of several different types of grass pollen, including Kentucky Blue Grass and Perennial Rye.

According to the FDA, this is the first sublingual (taken under the tongue) allergen extract that has been approved for use in the US. The medication is taken once a day by placing the tablet under the tongue, where it quickly dissolves.

Studies of Oralair in US and Europe involved around 2,500 participants who received either Oralair or a placebo, an inactive sugar pill. Patients then reported on their symptoms and if they needed to rely on other medications during allergy season.

"During treatment for one grass pollen season, patients taking Oralair experienced a 16 to 30 percent reduction in symptoms and the need for medications compared to those who received a placebo," reported the FDA.

The most commonly reported side effects seen in the studies were itching of the ears, mouth and tongue, swelling of the mouth and irritation of the throat.

Oralair does come with the warning that a severe allergic reaction, including the life-threatening, whole-body reaction of anaphylaxis, is possible.

For this reason, FDA stressed that the first dose of Oralair should be administered in a health care provider's office. If no adverse reactions arise, the medication can then be taken at home.

This ability to take the medication at home presents a new option for allergy patients, explained Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, in the FDA's announcement.

“While there is no cure for grass pollen allergies, they can be managed through treatment and avoiding exposure to the pollen,” said Dr. Midthun. “The approval of Oralair provides an alternative to allergy shots that must be given in a health care provider’s office.”

The medication is intended to relieve the uncomfortable symptoms of allergic rhinitis, often called hay fever, and conjunctivitis, or inflammation of the eye. People with these allergic reactions may cope with issues like chronic sneezing, nasal congestion and itchy eyes. FDA estimated that 30 million Americans experience these conditions.

FDA noted that the medication should be started around four months before the grass pollen season begins and should be continued as the season goes on.

Review Date: 
April 3, 2014
Last Updated:
April 3, 2014