Ista Pharmaceuticals' Beposone (bepotastine besilate / steroid) nasal spray showed improvements in patients' nasal symptoms associated with seasonal allergic rhinitis.
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 environmental clinical study is designed to assess the safety and efficacy of Beposone dosed twice daily in patients with allergic rhinitis caused by Mountain Cedar pollen.
In the study, approximately 600 patients aged 12 years and older were treated twice a day for two weeks with one of four formulations: bepotastine besilate / steroid combination, a nasal spray containing one or the other of the two active agents, or a placebo nasal spray.
The trial demonstrated that as early as day one of treatment with Beposone and bepotastine nasal sprays, nasal symptom improvement was superior to the placebo and improvements with the steroid nasal spray were observed on day three.
The changes in mean Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) grades for Beposone and single agent nasal sprays over the two-week treatment period were better for overall quality of life (QOL) improvements and for improvements in most, or all, individual QOL domain grades compared to the placebo nasal spray.
Timothy McNamara, Ista Pharmaceuticals Clinical Research and Medical Affairs vice president, said the encouraging 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, which were reported last year, we expect to complete some additional phase 2 studies ahead of our phase 3 pivotal programme covering both products, slated to begin in 2013," McNamara added.
"Beposone and Bepomax represent exciting potential expansions of our prescription allergy product line, currently focused on Bepreve (bepotastine besilate ophthalmic solution) 1.5% for the treatment of ocular itching associated with allergic conjunctivitis."