Bepotastine besilate is a non-sedating, antagonist of the histamine H1 receptor that acts by suppressing the migration of eosinophils into inflamed tissues.
The Phase 2 randomised placebo-controlled parallel-group multi-centre double-masked environmental clinical study evaluated the safety and efficacy of Beposone, dosed twice daily.
In the study, approximately 600 patients aged 12 years and old were treated twice per day for two weeks with one of four formulations: bepotastine besilate/steroid combination nasal spray (Beposone), containing one or the other of the two active agents, or placebo nasal spray.
The trial reported that nasal symptom improvement was found superior to placebo as early as day 1 of treatment with Beposone and bepotastine nasal sprays, and with steroid nasal spray beginning on day 3.
Ista Pharmaceuticals Clinical Research and Medical Affairs vice president Timothy McNamara said the Phase 2 data showed promise for the use of a combination bepotastine besilate/steroid nasal spray for treating allergic rhinitis.
"Based on these results and the positive Phase 2 results from our single-agent antihistamine nasal spray of bepotastine besilate, BEPOMAX(TM), which were reported last year, we expect to complete some additional Phase 2 studies ahead of our Phase 3 pivotal program covering both products, slated to begin in 2013," McNamara added.