FDA APPROVES ALTANA'S NASAL SPRAY FOR RHINITIS

The FDA has announced the approval of Altana's 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 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.

Seasonal allergic rhinitis is the most common allergic disease. Roughly 35 million Americans suffer from this condition.

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