Teva Pharmaceutical Industries Ltd. announced positive top-line results from Phase III trials that tested the efficacy and safety of fluticasone propionate/salmeterol and fluticasone propionate multidose dry powder inhalers (MDPIs) in adolescent and adult patients with Asthma.
Teva Respiratory develops and delivers high-quality treatment options for respiratory conditions, including asthma, COPD and allergic rhinitis. The company’s respiratory pipeline and clinical trial program consists of drug molecules delivered in proprietary dry powder formulations and breath-actuated device technologies, as well as a targeted biologic treatment for inadequately controlled asthma.
The three Phase III Trials, FSS-AS-301, FSS-AS-30017 and FSS-AS-305, consisted of 12-week, global, multicenter, randomized, double-blind, placebo-controlled evaluated increasing doses, from 50 to 200 mg of fluticasone propionate multidose dry powder inhaler (MDPI) compared with fluticasone propionate/salmeterol multidose dry powder inhaler (MDPI) twice a day in patients 12 years of age and older with persistent asthma during 12 or 26 weeks. Fluticasone propionate/salmeterol is a combination inhaled corticosteroid (ICS) and long-acting beta agonist (LABA) delivered via a multidose dry powder inhaler (MDPI) and fluticasone propionate.
The studies revealed greater efficiency of fluticasone propionate/salmeterol delivered through multi-dose dry-powder inhaler (MDPI) when compared to fluticasone propionate monotherapy and placebo. Notably, the studies also demonstrated similar general safety profiles as compared to therapies in the respective drug classes. Most side effects were mild to moderate in severity and there were no drug-related deaths during the trials. Currently, more analyses of additional efficacy and safety data are being performed. All data will be presented at upcoming scientific meetings and published in peer reviewed journals.
Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development, said that these findings support the company’s dedication to further optimize respiratory disease therapies by developing devices and treatments that help address the needs of patients and physicians.
Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva said that the company has made considerable progress in expanding the respiratory pipeline by focusing on a full asthma management system through the breath-actuated MDPI platform. He added that these findings continue the expansion of the company’s portfolio in the development of advanced respiratory therapeutic options.
In 2016, Teva plans to perform regulatory submissions for both fluticasone propionate/salmeterol MDPI and fluticasone propionate MDPI in the United States.