FDA Approves New Drug for Hay Fever

Oct. 25, 2006 -- The FDA has approved a new drug designed to help combat hay fever.

Omnaris nasal spray has been approved to treat nasal symptoms like runny nose associated with seasonal and yearlong allergiesallergies in adults and children 12 years and older.

An estimated 35 million Americans suffer from seasonal allergic rhinitis, which is the term for an inflamed, itchy, and runny nose from seasonal allergies.

Omnaris is part of a class of drugs called corticosteroids that suppress the immune response involved in allergies.

Omnaris vs. Placebo

The drug's approval was based on four clinical trials that ranged from two weeks to a year. The studies showed people treated with the nasal spray had an 8%-10% greater reduction in nasal hay fever symptoms -- including runny nose, nasal itching, sneezing, and nasal congestion -- compared with placebo.

The most commonly reported side effects of Omnaris were headache, nosebleeds, and inflammation of the nose and throat linings.

Omnaris is manufactured by Altana Pharma US Inc. of Florham Park, N.J.

Other steroid nasal sprays that are already available include Flonase, Nasonex, Rhinocort Aqua, Nasacort AQ, and Nasarel.

SOURCE: News release, FDA.