INSPIRE BEGINS TRIALS OF SEASONAL RHINITIS NASAL SPRAY
Inspire Pharmaceuticals announced that an investigational new drug application (IND) for epinastine nasal spray has been filed with the FDA and is in effect, having passed the 30-day review period. Inspire previously acquired certain exclusive rights from Boehringer Ingelheim to develop and market an intranasal dosage form of epinastine in the United States and Canada for the treatment or prevention of rhinitis.
Inspire has begun Phase II clinical testing in patients with seasonal allergic rhinitis based on the existing data package on epinastine, including Phase I safety data. The Phase II program will include clinical and toxicology studies to determine the optimal formulation and dose. The initial clinical trial compares several formulations and concentrations over one day.
Boehringer Ingelheim markets the oral form of epinastine as Flurinol in South America and as Alesion in Japan for the treatment of seasonal allergies, according to the company's website.