Ista announced the positive topline results of the phase II trial evaluating Beposone nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis.
Beposone is a fixed dose combination of bepotastine and a steroid. The phase II trial was a randomized, multicenter, double-masked, placebo-controlled, parallel-group environmental
trial evaluate the safety and efficacy of beposone given twice daily in patients with symptoms of allergic rhinitis caused by Mountain Cedar pollen.
The trial enrolled approximately 600 subjects who were 12 years and older. Each subject was randomized into one of the following groups: bepotastine besilate/steroid combination nasal spray, nasal spray containing bepotastine alone, nasal spray containing steroid alone, or placebo nasal spray. Subjects were educated to use the assignment treatment twice a day for two weeks.
The study evaluated the efficacy of the drug using the validated Rhinoconjunctivitis Quality of Life Questionaire conducted at the beginning of the trial and at the end of the trial.
The results showed that Beposone produced a statistically significant improvement in reducing total nasal symptoms when compared to placebo.
The most commonly observed adverse event in the use of Beposone were taste, nasal discomfort, headache, and nosebleed.
Bepotastine is a non-sedating, highly selective histamine receptor antagonist. The agent has been shown to stabilizing the effect on mast cells and suppresses the migration of eosinophils into inflamed tissues. Originally developed by Tanabe and Ube industries in Japan. Tanabe and Senju have acquired exclusive worldwide rights except for certain Asian countries to develop, manufacture and market bepotastine for ophthalmic use. The agent has been approved in Japan for the treatment of allergic rhinitis and urticaria/dermal prurituses. It is marketed by Mitsubishi Tanabe in Japan as Talion.
Ista obtained exclusive north American ophthalmic rights to the agent from Senju in 2006. The company then obtained exclusive North American rights to nasal dosage forms from Tanabe the following year. It has obtained a future right for a North American license to the oral dosage forms of the agent for allergy treatment.
Since then, Ista has marketed bepotastine 1.5% ophthalmic solution in the US for the treatment of ocular itching associated with allergic conjunctivitis.