Sunovion is presenting results from a 26-week double-blind, randomized Phase 3 study of ciclesonide HFA nasal aerosol involving more than 1,100 patients with perennial allergic rhinitis (PAR) that showed statistically significant improvement in nasal symptoms for ciclesonide compared to placebo. The study demonstrated positive results for both a 74 mcg dose and a 148 mcg dose. Nycomed, which licensed US development, marketing, and commercialization rights to ciclesonide to Sunovion in 2008, filed an NDA for the ciclesonide nasal aerosol with a proposed dose of 74 mcg in June 2011.
Lead investigator William E. Berger, Clinical Professor, Department of Pediatrics, University of California, Irvine said, “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. We are encouraged by these findings from this Phase 3 study in PAR patients investigating ciclesonide nasal aerosol in an HFA propellant.”
“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). 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,” commented Sunovion VP of Clinical Development and Medical Affairs Alistair Wheeler.
Read the Sunovion press release.
