Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced results from a Phase III study of QNAZE™ (beclomethasone dipropionate [BDP]) HFA, a nasal aerosol corticosteroid in development for the treatment of seasonal allergic rhinitis (SAR), that demonstrated significantly greater symptom relief compared with placebo. The results, presented at the 2010 Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in Phoenix, Ariz., showed that the non-aqueous formulation met all primary and secondary efficacy endpoints, and that the product demonstrated safety similar to placebo.
“We embarked on the QNAZE™ development program because we know there remain unmet needs amongst the 60 million Americans who suffer with allergic rhinitis that could be addressed by an aerosolized delivery of an intranasal steroid”
In addition to the Phase III SAR trial, Teva is also evaluating the safety and efficacy of QNAZE™ in the treatment of perennial allergic rhinitis (PAR). The PAR studies are still underway at the time of this release.
"The results of this pivotal clinical trial suggest that QNAZE™ HFA may be efficacious and safe for individuals seeking relief from the nasal symptoms associated with their seasonal allergies," said Jay van Bavel, M.D., Allergy and Asthma Associates, Austin, Texas, and lead investigator for the study.
Intranasal corticosteroids are often used as first-line therapy for the treatment of allergic rhinitis. Currently, the only intranasal steroids (INS) available are products with an aqueous or "wet" spray. Aerosol spray formulations became unavailable in the U.S. following the U.S. Food and Drug Administration's (FDA) decision to phase out all metered dose inhalers (MDIs) that used ozone-depleting chlorofluorocarbon (CFC) propellants. QNAZE™ is delivered in an aerosol formulation propelled by hydrofluoroalkane (HFA). This formulation is "dry" and the propellant is environmentally friendly.
"We embarked on the QNAZE™ development program because we know there remain unmet needs amongst the 60 million Americans who suffer with allergic rhinitis that could be addressed by an aerosolized delivery of an intranasal steroid," said Prof. Yitzhak Peterburg, Teva's Group Vice President, Global Branded Products.
Teva Pharmaceutical Industries Ltd.