Phase III trials of fluticasone propionate/salmeterol inhalers meet primary endpoints in asthma-Teva Pharmaceuticals

Teva Pharmaceutical Industries announced positive top-line results from three Phase III clinical studies designed to evaluate the efficacy and safety of fluticasone propionate/salmeterol, a combination inhaled corticosteroid (ICS) and long-acting beta agonist (LABA) delivered via a multidose dry powder inhaler (MDPI), and fluticasone propionate, an ICS monotherapy delivered via a MDPI, in adolescent and adult patients with asthma. Top-line data showed that the studies met their primary endpoints. Importantly, the studies also showed similar overall safety profiles as compared to therapies in the corresponding drug classes. Fluticasone propionate/salmeterol MDPI demonstrated, in the double-blind studies, clinically relevant and greater benefit at all doses (50/12.5, 100/12.5, and 200/12.5 mcg BID nominal delivered doses) versus placebo and versus respective monotherapy (fluticasone propionate) in the improvement of lung function as measured by the change from baseline in trough Forced Expiratory Volume in one second (FEV1) at the 12-week trial period and standardized baseline-adjusted area under the effect curve FEV1 from time 0 to 12 hours post dose at Week 12.

This initial set of results shows the adverse event profile of fluticasone propionate/salmeterol MDPI was comparable to fluticasone propionate monotherapy and placebo. The majority of adverse events were mild to moderate in severity. There were no drug-related deaths across any of the trials. Further analyses of additional efficacy and safety data are ongoing. Full results will be submitted for presentation at future scientific meetings and for publication in peer reviewed journals. Regulatory submissions for both fluticasone propionate/salmeterol MDPI and fluticasone propionate MDPI in the U.S. are planned for 2016.