ISTA Pharmaceuticals Inc. (ISTA) announced it has initiated a Phase 2 clinical study of its BEPOSONE nasal spray combining bepotastine besilate with a steroid for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies.
The randomized, placebo-controlled, parallel-group environmental study will evaluate the safety and efficacy of the combination nasal spray, dosed twice daily, in patients presenting with allergic rhinitis caused by one of the most potent seasonal allergy triggers, Mountain Cedar pollen.
ISTA said that it expects to enroll approximately 600 patients in Texas who will be treated with either the bepotastine besilate-steroid combination nasal spray, nasal spray containing only one of the active agents, or placebo nasal spray for two weeks. Patients will grade both individual nasal and ocular symptoms on a daily basis during the treatment period.
ISTA said that it submitted the Investigational New Drug Application to the U.S. Food and Drug Administration for BEPOSONE nasal spray in October 2011. The company expects to report results of this Phase 2 clinical study for BEPOSONE in the first half of 2012.
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