FDA approves Omnaris, new hay fever drug

Oct 23 2006

The U.S. Food and Drug Administration (FDA) has announced the approval of Omnaris (ciclesonide) nasal spray, a new drug for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis, commonly known as hay fever, in adults and children 12 years of age and older.

Although the precise way Omnaris works is unknown, the drug is a corticosteroid. Corticosteroids are hormone-like drugs that suppress the immune response.

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, and 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.

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 8-10 percent greater reduction in nasal symptoms compared to placebo. The difference between Omnaris nasal spray and placebo was significant.

The most common side effects 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, NJ.

http://www.fda.gov