A phase 3 study of a new treatment for chronic obstructive pulmonary disease (COPD) found no new safety issues.
Theravance Biopharma, Inc. and Mylan N.V. recently released positive results from a 12-month phase 3 safety study for the development the COPD treatment revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA) and a proposed once-daily nebulized bronchodilator.
In the study of 1055 COPD patients, the researchers did not identify any new safety issues and the rates of adverse events and serious adverse events were minimal.
"The data from this 12-month safety study build on our observations from the previous 3-month efficacy studies and suggest that revefenacin has a favorable safety and tolerability profile when dosed chronically, either as a standalone therapy or when taken as an add-on to other COPD therapies including combinations of [inhaled corticosteroids] and LABA," Brett Haumann, MD, chief medical officer at Theravance Biopharma, said in a press release
The researchers utilized a randomized, active-controlled parallel group trial in order to assess the safety of revefenacin. The study tested 2 doses of revefenacin—88mcg or 175 mcg, inhaled once daily with a nebulizer, over 52 weeks—and was compared to Tiotropium, which was administered through a handheld device.
In addition, 50% of patients used alternative COPD treatments, including long-acting beta-agonists (LABA) or LABA/inhaled corticosteroids. Although low rates of mortality and adverse events were reported, the most common types included exacerbations, nasopharyngitis, upper respiratory tract infections, and cough.
The safety demonstrated in this study, and the proven efficacy in the previous phase 3 efficacy studies, will be used as support for the new drug application for revefenacin to the FDA for approval for COPD treatment.
"Our revefenacin collaboration with Theravance Biopharma continues to deliver results at every step along the development path," said Rajiv Malik, president of Mylan. “We are very pleased with the top-line results from the 12-month safety trial and now feel we have all the data necessary to support a successful NDA filing. Should revefenacin receive approval from the FDA, we look forward to introducing this nebulized LAMA, to ensure the treatment has the greatest possible impact on the lives of patients with COPD.”