Bepotastine besilate is a non-sedating, highly selective antagonist of the histamine H1 receptor, approved in Japan for systemic use in the treatment of allergic rhinitis.
The Phase 2 clinical study is a randomized placebo-controlled parallel-group environmental study designed to investigate the safety and efficacy of combination nasal spray, dosed twice daily, in patients with allergic rhinitis caused by Mountain Cedar pollen.
The study will randomize around 600 patients with either bepotastine besilate-steroid combination nasal spray, nasal spray containing only one of the active agents, or placebo nasal spray for two weeks.
Ista Pharmaceuticals Clinical Research and Medical Affairs vice president Timothy McNamara said the first Phase 2 study of Bepomax (bepotastine besilate) as a single agent nasal spray demonstrated that each of three concentrations attained improvements in patients’ nasal symptoms over placebo following exposure to Mountain Cedar pollen.
Ista has submitted the Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for Beposone nasal spray, and plans to report Phase 2 study results of Beposone in the first half of 2012.
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