Ista Pharmaceuticals' Beposone nasal spray has entered into a Phase II clinical study in conjugation with bepotastine besilate and a steroid for the treatment of the symptoms associated with seasonal allergic rhinitis.
The randomised, placebo-controlled and parallel-group environmental study is intended to assess the safety and efficacy of twice-daily dosage of the combination nasal spray in patients with allergic rhinitis caused by one of the most potent seasonal allergy triggers, Mountain Cedar pollen.
The study will involve around 600 patients, who will be treated for two weeks with a bepotastine besilate-steroid combination nasal spray, a nasal spray containing only one of the active agents or placebo nasal spray.
Ista Pharmaceuticals clinical research and medical affairs vice-president Timothy McNamara said that the first Phase II study of Bepomax (bepotastine besilate) as a single agent nasal spray demonstrated that each of three concentrations attained improvements in patients' nasal symptoms compared with a placebo following exposure to Mountain Cedar pollen.
"Based upon extensive conversations with allergists to determine their prescribing habits and treatment preferences, we expanded our bepotastine besilate nasal spray programme to add development of a bepotastine-steroid combination product since antihistamines and steroids are often prescribed together for treatment of seasonal allergic rhinitis,'' McNamara said.
''With one marketed eye care product for ocular itch associated with allergic conjunctivitis, Bepreve, and the potential for two nasal formulations for allergic rhinitis, Bepomax and Beposone, our bepotastine besilate therapeutic franchise could offer important options to address the majority of patients' seasonal allergy symptoms."
In October 2011, the company submitted the Investigational New Drug application to the US Food and Drug Administration (FDA) for Beposone nasal spray, and anticipates to present Phase II study data of Beposone in the first half of 2012.
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.