ISTA Pharmaceuticals says that it has initiated a Phase 2 study of its Beposone bepotastine besilate/steroid combination nasal spray for the treatment of seasonal allergic rhinitis. Approximately 600 patients with allergic rhinitis caused by mountain cedar pollen are expected to take part in the randomized, placebo-controlled, parallel-group environmental study, which will be conducted in Texas. The company expects to complete the study by mid-2012.
A Phase 2 study of ISTA’s Bepomax nasal spray, a formulation of bepotastine besilate, demonstrated significantly significant improvement in nasal symptoms compared to placebo for three different combinations. The company already markets a bepotastine opthalmic formulation. ISTA licensed nasal dosage rights for bepotastine in North America from Tanabe Seiyaku in 2007 and filed an IND for Beposone in October 2011.
ISTA VP of Clinical Research and Medical Affairs Timothy R. McNamara commented, “Based upon extensive conversations with allergists to determine their prescribing habits and treatment preferences, we expanded our bepotastine besilate nasal spray program to add development of a bepotastine-steroid combination product since antihistamines and steroids are often prescribed together for treatment of seasonal allergic rhinitis.”
Read the ISTA press release.
