Sunovion Pharmaceuticals has announced publication of data from a year-long safety study showing an approximately 40% lower risk of COPD exacerbation-related hospitalization or death due to respiratory disease for patients using Brovana arformoterol tartrate inhalation solution than for patients using a placebo. The data were published online in Chest on June 26, 2014. Sunovion earlier presented data from the study at ATS 2013.
The study involved 841 COPD patients, 466 of whom completed the entire year of treatment. While 15% of patients using the placebo experienced a first COPD exacerbation related hospitalization or died from respiratory causes, the percentage of patients treated with Brovana experiencing those types of events was 9.5%.
Sunovion VP, Clinical Development and Medical Affairs Alistair Wheeler commented, “The data from the Large Simple Safety Study reinforce the long-term safety and efficacy of Brovana as a maintenance treatment for COPD and serve to demonstrate the impact of a long acting bronchodilator administered via nebulization. As part of our commitment to respiratory care, these findings underscore our dedication to delivering impactful treatments for patients.”
Executive VP and Chief Commercial Officer Richard Russell added, “Sunovion has a long history in providing therapies for patients suffering from respiratory disease. This study represents the completion of our post-marketing commitment to the FDA. More importantly it adds to the growing body of evidence concerning the safety profile of Brovana and reinforces it as an important and relevant option for appropriate patients with COPD. We are extremely proud of the results from this study.”
Brovana was originally approved by the FDA in October 2006.
Read the Sunovion press release.
Read the Chest abstract.
