Inspire Pharmaceuticals has announced today plans to file an investigational new drug (IND) application and begin Phase II clinical testing of intranasal epinastine for the treatment of seasonal allergic rhinitis, following the recent completion of a pre-IND meeting with the FDA.
The company expects to submit the IND application for intranasal epinastine in the third quarter of 2006 and begin clinical testing by year-end 2006. The Phase II program will include clinical and toxicology studies to determine the optimal formulation and dose. The primary Phase II trial is expected to be a 14-day dose-ranging trial in 600 to 700 subjects with seasonal allergies.