There were multiple secondary endpoints in this trial. Among these, statistically significant improvements (p less than or equal to 0.05) compared to placebo were demonstrated in the 0.1% dose group for the secondary endpoints of non-nasal symptom score (itchy eyes, watery eyes, and itchy throat/palate) and for total symptom score (TNSS plus non-nasal symptom score).
Based on the results of this trial and previous discussions with the FDA, Inspire intends to initiate a required 6-month nasal toxicology study of epinastine in a single animal species to support longer-term clinical trials. In addition, a meeting with the FDA will be scheduled to discuss the next steps in the clinical program.
In 2006, Inspire acquired certain exclusive rights from Boehringer Ingelheim International GmbH to develop and market epinastine nasal spray in the United States and Canada for the treatment or prevention of rhinitis.
Inspire is a biopharmaceutical company dedicated to discovering, developing and commercializing prescription pharmaceutical products in disease areas with significant commercial potential and unmet medical needs. Inspire employs a U.S. sales force for the promotion of AzaSite (azithromycin ophthalmic solution) 1% for bacterial conjunctivitis, Elestat(R) (epinastine HCl ophthalmic solution) 0.05% for allergic conjunctivitis and Restasis(R) (cyclosporine ophthalmic emulsion) 0.05% for dry eye. Inspire is focused on the therapeutic areas of ophthalmology and respiratory/allergy, and is developing products for dry eye, cystic fibrosis, allergic rhinitis and glaucoma. Elestat and Restasis are trademarks owned by Allergan, Inc. AzaSite is a trademark owned by InSite Vision Incorporated. For more information, visit www.inspirepharm.com.
The forward-looking statements in this news release relating to
management's expectations and be