The revefenacin phase 3 program, which includes two replicate efficacy trials and a single twelve-month safety study, is designed to support the product’s registration in the US.
Theravance enrolled over 2,300 patients across the three studies in about eight months. Top-line data from the two efficacy studies are anticipated to be available in late-third quarter or early-fourth quarter of this year, with the data from the twelve-month safety trial following in 2017.
The ongoing phase 3 efficacy and safety studies are testing two doses (88 mcg and 175 mcg) of revefenacin inhalation solution administered once daily through nebulizer in moderate to severe COPD patients.
The phase 3 efficaccy trials are replicate, randomized, double-blind, placebo-controlled, parallel-group studies designed to offer pivotal efficacy and safety data for once-daily revefenacin for a twelve-week dosing period, with a primary endpoint of trough forced expiratory volume in one second on day 85.
The phase 3 twelve-month safety trial is an open-label, active comparator study.
If all the studies generate positive outcomes, Theravance anticipates to file a new drug application for revefenacin with the United States Food and Drug Administration (FDA) by the end of 2017.
Theravance and its affiliates have partnered with Mylan and its affiliates to develop and commercialize nebulized revefenacin products for COPD and other respiratory diseases.
Theravance Biopharma chief medical officer Brett Haumann said: "Based on its competitive advantages, including once-daily dosing and compatibility with any standard jet nebulizer, we believe that, if approved, revefenacin has the potential to benefit a significant number of COPD patients who require once-daily LAMA treatment but for whom handheld inhaler devices are not suitable."