November 5, 2011
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Sunovion Pharmaceuticals Inc. (Sunovion) today appear after-effects from a ample Phase III analytic abstraction of ciclesonide nasal aerosol, a corticosteroid formulated with a hydrofluoroalkane (HFA) propellant, advised for the analysis of allergic rhinitis. This 26 week, double-blind, randomized study, advised 74 mcg or 148 mcg doses of ciclesonide nasal aerosol once-daily in 1,111 patients, 12 years of age and earlier with abiding allergic rhinitis (PAR). Statistically cogent improvements in nasal affection were approved in patients with PAR compared to placebo, afterwards the aboriginal six weeks of double-blind treatment, for both the 74 mcg and 148 mcg doses. After-effects from the abounding 26 week, double-blind analysis aeon approved tolerability of both the 74 mcg and 148 mcg doses of ciclesonide nasal aerosol compared to placebo. Data from the aboriginal six weeks of analysis as able-bodied as the abounding six months of abstraction analysis were presented in four abstracted accurate posters at the 2011 anniversary affair of the American College of Allergy, Asthma & Immunology (ACAAI) in Boston, Massachusetts.
“These after-effects abutment our development affairs for ciclesonide nasal aerosol and accentuate our company's charge to developing treatments for patients adversity from respiratory ailments.”
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In prospectively advised analyses, statistically and clinically cogent improvements with 74 mcg of ciclesonide nasal aerosol in all-embracing rhinoconjunctivitis-related affection of life, as abstinent by the Rhinoconjunctivitis Affection of Activity Questionnaire with Standard Activities (RQLQ[S]) over the aboriginal six weeks was additionally demonstrated, with a analysis aberration of 0.55 compared with placebo for patients with a baseline RQLQ[S] account of ≥ 3.0. The best accustomed adverse contest (≥ 2% for the 74 mcg dosage and greater than placebo) were cephalalgia and epistaxis.
"Perennial allergic rhinitis has a cogent aftereffect on millions of bodies civic and advisers and industry are committed to developing new and avant-garde analysis options to abode a advanced array of accommodating needs," said advance investigator William E. Berger, MD, Analytic Professor, Department of Pediatrics, University of California, Irvine and Past President of American College of Allergy, Asthma, and Immunology. "We are encouraged by these allegation from this Phase III abstraction in PAR patients investigating ciclesonide nasal aerosol in an HFA propellant."
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The charge arrangement in development is advised to allocate ciclesonide medication as a accomplished dry brume in a baby aggregate (50 mcL) to a patient's nose, which may be able to abate acoustic furnishings such as back-of-the-throat run-off and run-out out of the adenoids that can action with aqueous-based corticosteroids.
"We are admiring to see after-effects for ciclesonide nasal aerosol in patients with PAR that are agnate to those ahead apparent in patients with melancholia allergic rhinitis (SAR)," said Alistair Wheeler, M.D., Vice President, Analytic Development and Medical Affairs at Sunovion Pharmaceuticals Inc. "These after-effects abutment our development affairs for ciclesonide nasal aerosol and accentuate our company's charge to developing treatments for patients adversity from respiratory ailments."
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The New Drug Application (NDA) for ciclesonide nasal aerosol was accustomed for filing by the U.S. Food and Drug Administration (FDA) in June 2011 and is currently beneath review. The proposed dosage for ciclesonide nasal aerosol for adolescents and adults 12 years of age or earlier is 74 mcg (one spray/nostril) daily.
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Sunovion Pharmaceuticals Inc.
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