Sunovion Pharmaceuticals Inc. (Sunovion) today announced results from a large Phase III clinical study of ciclesonide nasal aerosol, a corticosteroid formulated with a hydrofluoroalkane (HFA) propellant, intended for the treatment of allergic rhinitis. This 26 week, double-blind, randomized study, investigated 74 mcg or 148 mcg doses of ciclesonide nasal aerosol once-daily in 1,111 patients, 12 years of age and older with perennial allergic rhinitis (PAR). Statistically significant improvements in nasal symptoms were demonstrated in patients with PAR compared to placebo, after the first six weeks of double-blind treatment, for both the 74 mcg and 148 mcg doses. Results from the full 26 week, double-blind treatment period demonstrated tolerability of both the 74 mcg and 148 mcg doses of ciclesonide nasal aerosol compared to placebo. Data from the first six weeks of treatment as well as the full six months of study treatment were presented in four separate scientific posters at the 2011 annual meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in Boston, Massachusetts.
“These results support our development program for ciclesonide nasal aerosol and underscore our company's commitment to developing treatments for patients suffering from respiratory ailments.”
In prospectively designed analyses, statistically and clinically significant improvements with 74 mcg of ciclesonide nasal aerosol in overall rhinoconjunctivitis-related quality of life, as measured by the Rhinoconjunctivitis Quality of Life Questionnaire with Standard Activities (RQLQ[S]) over the first six weeks was also demonstrated, with a treatment difference of 0.55 compared with placebo for patients with a baseline RQLQ[S] score of ≥ 3.0. The most common adverse events (≥ 2% for the 74 mcg dose and greater than placebo) were headache and epistaxis.
"Perennial allergic rhinitis has a significant effect on millions of people nationwide and researchers and industry are committed to developing new and innovative treatment options to address a wide variety of patient needs," said lead investigator William E. Berger, MD, Clinical Professor, Department of Pediatrics, University of California, Irvine and Past President of American College of Allergy, Asthma, and Immunology. "We are encouraged by these findings from this Phase III study in PAR patients investigating ciclesonide nasal aerosol in an HFA propellant."
The delivery system in development is designed to dispense ciclesonide medication as a fine dry mist in a small volume (50 mcL) to a patient's nose, which may be able to reduce sensory effects such as back-of-the-throat run-off and run-out out of the nose that can occur with aqueous-based corticosteroids.
"We are pleased to see results for ciclesonide nasal aerosol in patients with PAR that are similar to those previously seen in patients with seasonal allergic rhinitis (SAR)," said Alistair Wheeler, M.D., Vice President, Clinical Development and Medical Affairs at Sunovion Pharmaceuticals Inc. "These results support our development program for ciclesonide nasal aerosol and underscore our company's commitment to developing treatments for patients suffering from respiratory ailments."
The New Drug Application (NDA) for ciclesonide nasal aerosol was accepted for filing by the U.S. Food and Drug Administration (FDA) in June 2011 and is currently under review. The proposed dose for ciclesonide nasal aerosol for adolescents and adults 12 years of age or older is 74 mcg (one spray/nostril) daily.