Ista Pharma releases Bepotastine besilate nasal spray Phase 1/2 study results

Ista Pharma said that the Phase 1/2 study was a double-masked, randomised, placebo-controlled, parallel-group study evaluating the safety and efficacy of three concentrations of Bepotastine besilate, dosed twice daily, in an Environmental Exposure Chamber (EEC) treatment model for allergic rhinitis.

Results from the Phase 1/2 clinical study showed that two of the three Bepotastine besilate concentrations tested were effective in relieving patients’ nasal symptoms after exposure to seasonal allergens and also showed that the drug to be well-tolerated

Following the positive results, Ista Pharma is planning to submit an investigational new drug (IND) application to the US Food and Drug Administration and to initiate Phase 2 clinical studies of Bepotastine besilate nasal spray before the end of 2010.

Ista Pharma Clinical Research and Medical Affairs vice president Timothy McNamara said that during the clinical trials for Bepreve, theirr twice-daily prescription eye drop for ocular itching associated with allergic conjunctivitis, patients noted improvement in nasal symptoms.

“The Phase 1/2 study data with Bepotastine besilate nasal sprays supports our initial findings with the Bepreve ophthalmic solution on the efficacy of Bepotastine for the treatment of nasal symptoms,” McNamara said.

“The results of our nasal bepotastine Phase 1/2 clinical study in Canada show a good patient response to the nasal spray without serious side effects, giving us confidence to move forward into Phase 2 clinical trials.

“Assuming timely filing of the IND application and timely commencement and completion of the Phase 2 studies, we expect to report preliminary Phase 2 data from the Mountain Cedar pollen study during the first half of 2011.”