Total Nasal Symptom Score

Currently, the intranasal spray (INS) market is composed only of aqueous or "wet feeling" products; however, prior to the U.S. Food and Drug Administration's (FDA) decision to phase out metered dose inhalers (MDIs) that contain chlorofluorocarbons (CFCs), the nasal market also included aerosol or "dry formulation" sprays. Teva's Nasal Aerosol utilizes an HFA propellant. Future studies will further examine the safety and efficacy profile of this product.

Based on results from the Phase I study that evaluated the pharmacokinetics, safety and tolerability of BDP HFA, the systemic exposure following administration of the treatment (up to 320 mcg/day) was approximately 27 percent of orally inhaled BDP HFA, which is marketed by Teva as the asthma treatment QVAR® (beclomethasone dipropionate HFA) Inhalation Aerosol. Based on these results, the established QVAR® safety data may provide further supportive evidence for the development of this "dry" nasal formulation for the treatment of allergic rhinitis.

Study Design and Results

The Phase III SAR trial was designed as a randomized, double-blind, placebo-controlled, parallel-group, clinical study to assess the efficacy and safety of BDP HFA Nasal Aerosol in the treatment of SAR in subjects 12 years of age and older. Over a two-week treatment period during the Mountain Cedar pollen season, 340 patients at four different sites in the U.S. were randomized to 320 mcg of BDP HFA propellant or placebo as a nasal aerosol daily. To measure efficacy in comparison to placebo, the study used the standard reflective Total Nasal Symptom Score (TNSS) for primary endpoints and instantaneous TNSS and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) for secondary endpoints..