New allergy treatment

FDA Consumer, Jan-Feb, 2007

Omnaris (ciclesonide) nasal spray was approved by the FDA in October 2006 to treat nasal symptoms associated with seasonal and perennial allergic rhinitis in adults and children 12 years of age and older.

Commonly known as hay fever, allergic rhinitis is the medical term for the inflamed, runny nose that's the main symptom of allergies. Seasonal allergic rhinitis is the most common allergic disease. About 35 million Americans suffer from this condition. The ailment's classic symptoms are watery nasal discharge, fits of sneezing, and itching that can affect not just the nose but the roof of the mouth, throat, and the Eustachian tubes, which connect the middle ear to the back of the throat.

Although the precise way Omnaris works is unknown, the drug is a corticosteroid. Corticosteroids are hormone-like drugs that suppress the immune response. The safety and efficacy of Omnaris nasal spray were studied in four randomized placebo-controlled clinical trials ranging in duration from two weeks to a year. The studies assessed how well Omnaris treated symptoms (runny nose, nasal itching, sneezing, and nasal congestion) in patients with hay fever. The results of these trials showed that patients treated with Omnaris nasal spray had an 8 percent to 10 percent greater reduction in nasal symptoms, compared with placebo. The difference between Omnaris nasal spray and placebo was significant.

The most common side effects of Omnaris in clinical studies were headache, nosebleeds, and inflammation of the nose and throat linings.

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