Zetonna available soon for allergic rhinitis
Zetonna (ciclesonide, Sunovion) nasal aerosol, approved in January 2012 to treat both ocular and nasal symptoms associated with seasonal allergic rhinitis (SAR), and nasal symptoms associated with perennial allergic rhinitis (PAR) in adults and adolescents aged >12 years, is expected to be commercially available in the third quarter of 2012.
The FDA granted Zetonna approval based on findings from a large phase-3 clinical study that investigated 74 mcg or 148 mcg doses of ciclesonide nasal aerosol once-daily in 1,111 patients aged 12 years and older with perennial allergic rhinitis (PAR). Compared with placebo, patients who received either dose of the ciclesonide spray experienced statistically significant improvements in nasal symptoms after the first six weeks of treatment.
Common adverse events included nasal discomfort, headache and epistaxis. Although rare, more serious adverse reactions include nasal septal perforation and nasal ulceration. Patients who have experienced recent nasal septal perforation, nasal erosion, nasal ulcers, nasal surgery or nasal trauma are advised not to use Zetonna until healing has occurred.
Zetonna is the only non-aqueous, dry nasal aerosol spray with one spray per nostril (37 mcg) and once-daily dosing. It features an easy-to-read, built-in dose indicator, so patients can track when their prescriptions should be refilled.
Zetonna contains the same active ingredient found in Omnaris (Sepracor) nasal spray, a hypotonic formulation indicated for the treatment of SAR and PAR, and Alvesco (Sepracor) inhalation aerosol, indicated for the maintenance treatment of asthma. For more information call (800) 739-0565 or visit www.sunovion.com.