Teva Pharmaceutical Industries has announced top-line results from three Phase 3 clinical studies of its generic fluticasone propionate/salmeterol DPI and a fluticasone propionate monotherapy DPI for the treatment of asthma. The company said that all of the studies met their primary endpoints and that it plans to submit regulatory applications to the FDA for both products in 2016.
The three studies included two 12-week efficacy and safety studies of fluticasone monotherapy compared to the combination therapy in asthma patients 12 years old and older who did not achieve sufficient control of symptoms with ICS therapy (FSS-AS-301 and FSS-AS-30017) and a 26-week safety study of both products in asthma patients 12 and older (FSS-AS-305).
Teva Senior VP, Global Respiratory Research and Development Tushar Shah said, “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. 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.”
Read the Teva press release.
