Teva Reports Positive Top-Line Results from Phase III Trials Evaluating Fluticasone Propionate/Salmeterol and Fluticasone Propionate Multidose Dry Powder Inhalers (MDPIs) in Patients with Asthma
Studies demonstrate greater efficacy with lower doses delivered via multidose dry-powder inhaler (MDPI) compared to placebo
Results showcase Teva’s expanding respiratory R&D capabilities and support advancement of core, breath-actuated MDPI platform
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today 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.
“These data support Teva’s commitment to further optimize the treatment of respiratory disease through the development of devices and therapies that help address the needs of patients and physicians,” said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. “With this dual development program we have demonstrated clinically significant levels of effectiveness, by delivering combination and monotherapy at lower doses utilizing our core, breath-actuated, MDPI platform.”
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.
Fluticasone propionate MDPI also demonstrated clinically relevant and greater benefit at all doses (50, 100, and 200 mcg BID nominal delivered doses) versus placebo in the improvement of lung function, in the double-blind studies. The initial set of results shows the adverse event profile of fluticasone propionate MDPI was comparable to 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.
“We have made significant progress in furthering our respiratory pipeline with a focus on a complete asthma management system utilizing our breath-actuated MDPI platform,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “We have successfully developed and launched products that utilize our breath-actuated MDPI platform in select markets around the world. These data support the broadening of our portfolio in using this technology to develop and deliver additional respiratory therapeutic options.”
Regulatory submissions for both fluticasone propionate/salmeterol MDPI and fluticasone propionate MDPI in the U.S. are planned for 2016.
About The Studies
Study FSS-AS-301 was a Phase III, 12-week, global, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of fluticasone propionate multidose dry powder inhaler (MDPI) compared with fluticasone propionate/salmeterol multidose dry powder inhaler (MDPI) in 1363 adolescent and adult patients with persistent asthma symptomatic despite low-dose or mid-dose inhaled corticosteroid therapy. Its primary objective was to evaluate the efficacy of fluticasone propionate MDPI (at two doses: 50 mcg BID or 100 mcg BID) and fluticasone propionate/salmeterol MDPI (at two doses: 50/12.5 mcg BID or 100/12.5 mcg BID) when administered over a 12-week period in patients 12 years of age and older with persistent asthma. For further details on the study, please visit: https://www.clinicaltrials.gov/ct2/show/NCT02139644
Study FSS-AS-30017 was a Phase III, 12-week, global, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of fluticasone propionate multidose dry powder inhaler (MDPI) compared with fluticasone propionate/salmeterol multidose dry powder inhaler (MDPI) in 1661 adolescent and adult patients with persistent asthma symptomatic despite inhaled corticosteroid therapy. Its primary objective was to evaluate the efficacy of fluticasone propionate MDPI (at two doses: 100 mcg BID or 200 mcg BID) and fluticasone propionate salmeterol MDPI (at two doses: 100/12.5 mcg BID or 200/12.5 mcg BID) when administered over a 12-week period in patients 12 years of age and older with persistent asthma. For further details on the study, please visit: https://www.clinicaltrials.gov/ct2/show/NCT02141854
Study FSS-AS-305 was a Phase III, 26-week, multicenter, open-label study to assess the long-term safety of fluticasone propionate multidose dry powder inhaler (MDPI) and fluticasone salmeterol/propionate multidose dry powder inhaler (MDPI) in 1087 adolescent and adult patients with persistent asthma. Its primary objective was to evaluate the long-term safety of fluticasone propionate inhalation powder (at two doses: 100 mcg BID or 200 mcg BID) and fluticasone propionate/salmeterol inhalation powder (at two doses: 100/12.5 mcg BID or 200/12.5 mcg BID) when administered with the Teva multidose dry powder inhaler (MDPI) device as compared to corresponding reference products over a 26-week period in patients 12 years of age and older with persistent asthma. For further details on the study, please visit: https://www.clinicaltrials.gov/ct2/show/NCT02175771
About Teva Respiratory
Teva Respiratory develops and delivers high-quality treatment options for respiratory conditions, including asthma, COPD and allergic rhinitis. The Teva Respiratory portfolio is centered on optimizing respiratory treatment for patients and healthcare providers through the development of novel delivery systems and therapies that help address unmet needs. The company’s respiratory pipeline and clinical trial program are based on drug molecules delivered in proprietary dry powder formulations and breath-actuated device technologies, as well as a targeted biologic treatment for inadequately controlled asthma. Through research and clinical development, Teva Respiratory continually works to expand, strengthen and build upon its treatment portfolio to positively impact the lives of the millions of patients living with respiratory disease.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions to millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,000 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva's net revenues in 2014 amounted to $20.3 billion. For more information, visit www.tevapharm.com.
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