FDA accepts Sunovion ciclesonide HFA nasal aerosol NDA for review

Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the New Drug Application (NDA) submitted for ciclesonide nasal aerosol in a hydrofluoroalkane (HFA) formulation has been accepted by the U.S. Food and Drug Administration (FDA). The proposed dosing for ciclesonide HFA nasal aerosol is 74 mcg once-daily (37 mcg per spray; one-spray per nostril) and the proposed indication is for the treatment for symptoms of Seasonal Allergic Rhinitis (SAR) and Perennial Allergic Rhinitis (PAR), in adults and adolescents age 12 and older. Sunovion has been granted exclusive development, marketing and commercialization rights for ciclesonide in the United States by Nycomed.

The NDA for ciclesonide HFA nasal aerosol reflects data from several clinical trials. The efficacy of ciclesonide HFA nasal aerosol was evaluated in three randomized, double blind, parallel-group, multi-center, placebo-controlled clinical trials with primary efficacy endpoints evaluated over 2 to 6 weeks duration conducted in the U.S. in adolescents and adults with allergic rhinitis. The three trials included a total of 2,488 subjects. Of these, 761 received the 74 mcg once-daily dose. The primary endpoint within the pivotal trials was the difference from placebo in the change from baseline of the average morning and evening reflective total nasal symptom scores (rTNSS). Additional efficacy endpoints assessed included reflective total ocular symptom scores (rTOSS) and quality of life measured via the use of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).

The safety data are based on five clinical trials evaluating doses of ciclesonide HFA nasal aerosol up to 282 mcg. One trial did not evaluate the 74 mcg dose. Four of the clinical trials were 2 to 6 weeks in duration and one trial was 26 weeks in duration. Data from the first 6 weeks of the 26 week trial were pooled with the short-term data from the other four studies. Short-term data of 2 to 6 weeks duration in the four short-term trials was evaluated, including 884 patients with SAR or PAR who were administered the 74 mcg dose.

The delivery system for ciclesonide HFA nasal aerosol is a pressurized metered-dose, nasal aerosol formulation designed to dispense a small volume (50 mcL) of the fine, dry mist of ciclesonide medication to a patient's nose.

"We are pleased to achieve this important regulatory milestone as part of the FDA review process for ciclesonide HFA nasal aerosol," said Antony Loebel, M.D., executive vice president of clinical research and affairs at Sunovion Pharmaceuticals Inc. "If approved after full review, ciclesonide HFA nasal aerosol will offer a new therapeutic option for the millions of individuals suffering with seasonal and perennial nasal allergies."

"Ciclesonide HFA nasal aerosol has the potential to be a valuable new treatment option for patients who suffer from seasonal and perennial allergies," said Michael Blaiss, M.D., Clinical Professor of Pediatrics and Medicine at The University of Tennessee Health Sciences Center. "If approved at the proposed dose, this new product could offer symptom relief with a low volume nasal spray."


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