Nasal spray approved for treatment of allergies

November 20, 2006

The Food & Drug Administration recently approved ciclesonide (Omnaris, Altana Pharma) for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in adults and children 12 years and older.

Allergic rhinitis, or hay fever, affects more than 35 million Americans. Symptoms range from brief, infrequent episodes of runny nose and itchy, watery eyes to persistent, severe symptoms lasting more than four days a week that may lead to inability to sleep, chronic malaise, and poor work or school efficiency.

"According to the FDA, there have been four randomized placebo-controlled studies, in which Omnaris seems to be similar in safety and efficacy to the other currently available nasal steroids. However, none of them have been published comparing the products," stated Orr. Three trials, two to six weeks in duration, included 1,524 patients randomized to receive ciclesonide nasal spray or placebo. They were primarily designed to assess efficacy based on patients recording their nasal symptoms on a categorical scale as reflective or instantaneous scores.

Patients treated with ciclesonide 200 mcg once daily exhibited greater decreases in total nasal symptom scores that were statistically significant compared with patients treated with placebo. The fourth trial was one year in duration and was primarily designed to assess safety.

The overall incidence of adverse events for patients treated with ciclesonide was comparable to that in patients treated with placebo. The most frequently reported adverse events in 546 patients who received ciclesonide 200 mcg daily for two to six weeks were headache, epistaxis, nasopharyngitis, and ear pain. The adverse-event profile of the long-term safety trial was similar to that of the shorter duration trials.

The ciclesonide nasal spray bottle should be shaken prior to use and primed by actuating it eight times. If the product is not used for four consecutive days, it should be shaken gently and reprimed with one spray or until a fine mist appears. Altana recommends that the bottle be discarded after 120 actuations following the initial priming or four months after the bottle is removed from the foil pouch, whichever comes first.

One of the concerns with ciclesonide, according to Orr, is whether it will be covered by insurance plans and how high the cost to the patient will be, since there are generic nasal steroids already on the market. Ciclesonide is supplied in an amber glass bottle and provides 120 metered sprays after initial priming.

TIPS TO REMEMBER Omnaris

THE AUTHOR is a writer based in New Jersey.