Sunovion launches ZETONNA Nasal Aerosol for allergic rhinitis

Sunovion Pharmaceuticals Inc. (Sunovion) today announced the nationwide availability of ZETONNA™ (ciclesonide) Nasal Aerosol, 74 mcg once-daily, for the treatment of allergic rhinitis (AR), also known as hay fever or nasal allergies. ZETONNA is a corticosteroid indicated for the treatment of symptoms associated with seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in adults and adolescents 12 years of age and older. It is the only dry nasal aerosol approved by the U.S. Food and Drug Administration (FDA) with once daily, one spray per nostril (37 mcg) dosing.

“I often hear from my patients that they are dissatisfied with the burden of allergies and are looking for alternative treatment options”

"I often hear from my patients that they are dissatisfied with the burden of allergies and are looking for alternative treatment options," said William E. Berger, M.D., clinical professor with the Department of Pediatrics, Division of Allergy and Immunology, University of California, Irvine and a practicing allergist in Mission Viejo, California. "Nasal corticosteroids like ZETONNA are efficacious treatments for allergic rhinitis. Now that we have the option of prescribing either an aqueous or dry delivery formulation of this steroid, we have another way of treating our patients' discomfort with allergies which may help them to achieve greater satisfaction."

In three Phase III clinical studies including almost 2,500 adults and adolescents 12 years of age and older, ZETONNA Nasal Aerosol was shown to significantly improve nasal symptoms of SAR and PAR. Additionally, it is the only dry nasal aerosol approved for the treatment of ocular symptoms associated with SAR. The most common adverse events reported were nasal discomfort, headache and nosebleed.

Patients taking ZETONNA reported improved quality of life associated with SAR as measured by the Rhinoconjunctivitis Quality of Life Questionnaire with Standardized Activities (RQLQ[S]), which is based upon evaluation of activity limitation, sleep problems, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems and emotional function.

Further, patients reported high levels of satisfaction with ZETONNA, based on the Regimen Attributes Composite subscale of the Allergic Rhinitis Treatment Satisfaction and Preference (ARTSP) instrument, a patient-reported outcome measure. These data were collected as part of a two-week, randomized, multicenter, two-period study involving 327 patients 12 years of age and older with PAR.

"ZETONNA joins OMNARIS^® (ciclesonide) Nasal Spray as the newest addition in Sunovion's ciclesonide franchise. These treatments offer different experiences for patients, as OMNARIS is an aqueous, once-daily, two spray per nostril option for SAR patients 6 and older and PAR patients 12 and older," said Richard Russell, executive vice president and chief commercial officer of Sunovion Pharmaceuticals Inc. "We are proud to be the only company to provide patients with the option of a dry aerosol or aqueous treatment, as well as a best-in-class co-pay program that allows qualified patients to pay as little as $17 a month for either ZETONNA or OMNARIS."

Allergic rhinitis is estimated to affect approximately 60 million people in the United States, and its prevalence is increasing. Approximately 13 million physician office visits each year are attributed to AR. Additionally, 3.6 million missed or lost workdays each year are attributed to AR, resulting in a total cost of about $450 million in total lost productivity.

Source Sunovion Pharmaceuticals Inc.