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ISTA Pharmaceuticals has initiated a phase I/II clinical study of bepotastine besilate nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis.
Irvine, CA-ISTA Pharmaceuticals has initiated a phase I/II clinical study of bepotastine besilate nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis.
The randomized, placebo-controlled, parallel-group study will evaluate the safety and efficacy of three concentrations of the histamine H1 receptor antagonist, dosed twice daily, in an environmental exposure chamber (EEC) model of allergic rhinitis caused by natural exposure to seasonal allergens. The study also will assess the pharmacokinetics (PK) of the investigational nasal sprays.
Following initial screening, 96 patients will be randomly assigned into the phase I/II clinical study. During the study, patients will be exposed to pollen in the EEC and will grade their individual symptoms at select time intervals before and after taking bepotastine nasal spray or placebo. Reported symptoms will include both nasal symptoms and ocular symptoms. Safety will be evaluated based on several variables, including adverse events, electrocardiograms, and the mean grades for questions on a brief satisfaction and tolerability questionnaire completed at the end of the study. In addition, PK data on the three dose concentrations of bepotastine nasal spray will be assessed based on blood draws from a subset of patients.
ISTA expects to complete the phase I/II clinical study of bepotastine nasal spray and announce preliminary results this fall.
“This milestone attests to the continuing momentum of our programs addressing the allergy market,” said Vicente Anido Jr., PhD, president and chief executive officer of the company.
ISTA’s eye-drop formulation of bepotastine 1.5% (Bepreve) was approved by the FDA in September 2009 for the treatment of ocular itching associated with allergic conjunctivitis.