NewsMonday, 01. August 2016
Sunovion Announces Results of Phase 3 Long-Term Safety Study
These data, along with positive results from Phase 3 efficacy trials, will support the Company's New Drug Application (NDA) submission to the FDA in 2016
MARLBOROUGH, Mass., July 22, 2016 – Sunovion Pharmaceuticals Inc. (Sunovion) today announced positive results from GOLDEN-5, a long-term safety study evaluating SUN-101 (glycopyrrolate), a nebulized, long-acting muscarinic antagonist (LAMA) delivered via an innovative investigational nebulizer system (SUN-101/eFlow®).
The study results showed that SUN-101/eFlow® was well-tolerated as a twice-daily maintenance treatment for bronchoconstriction in people with moderate-to-very severe chronic obstructive pulmonary disease (COPD), with a similar overall incidence of adverse events to standard of care treatment. Results also showed that the incidence of major adverse cardiovascular events (MACE) was similar to the approved active comparator.
“Sunovion has a longstanding history of advancing treatment options for patients with COPD,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion. “The results from the GOLDEN-5 study further build on the strong safety and efficacy profile we have seen in our previous Phase 3 studies, and we look forward to advancing SUN-101/eFlow® through the regulatory process as the first nebulized LAMA for patient use.”
"As a physician, it is always gratifying when I can tell my patients that there are new treatment options that may help them manage their COPD," said Nicola Hanania, M.D., Associate Professor, Baylor College of Medicine. “If approved, SUN-101/eFlow® could be a breakthrough for COPD patients, allowing for delivery of glycopyrrolate via a state-of-the-art device which combines the attributes of nebulizers and hand-held devices."
The innovative, proprietary eFlow® nebulizer system, developed by PARI Pharma GmbH, is a unique closed system delivery device currently in development for the treatment of moderate-to-very severe COPD. It is a portable, hand-held, electronic nebulizer system that uses a vibrating, perforated membrane to generate an inhalable aerosol. The eFlow® nebulizer closed system is designed to deliver the entire dose of medication in two to three minutes from a distinctive proprietary drug vial inserted into the device. A standard jet nebulizer typically takes up to 10 minutes. The investigational combined product, consisting of SUN-101 and the eFlow® nebulizer closed system, has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of COPD.
Sunovion will present data from the GOLDEN-5 study at an upcoming medical meeting. Along with the recently reported Phase 3 efficacy studies GOLDEN-3 and GOLDEN-4, the GOLDEN-5 long-term safety data will support the SUN-101/eFlow® New Drug Application (NDA), anticipated for submission to the FDA during 2016.
About the GOLDEN-5 Clinical Trial
GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer)-5 was a Phase 3, 48-week, randomized, open-label, active-controlled, parallel-group, multicenter safety trial designed to evaluate the long term safety and tolerability of SUN-101/eFlow® in adults with moderate-to-very severe COPD. The study enrolled 1,087 patients at 111 investigational sites in the United States and Europe. The study evaluated 50 mcg of SUN-101/eFlow® delivered twice-daily and active comparator 18 mcg of Spiriva® (tiotropium bromide) delivered once-daily by the HandiHaler® device. The primary safety endpoints were: the number and percentage of study participants with treatment-emergent adverse events (TEAE), the number and percentage of study participants with treatment-emergent serious adverse events (SAE) and the number and percentage of study participants who discontinued the study due to TEAEs. The secondary endpoints are the mean change from baseline over 48 weeks in trough forced expiratory volume in one second (FEV1) for all subjects and number and percentage of subjects with MACE [NCT02276222].
The study was unique in that it included not only patients who were taking effective background long acting bronchodilator therapy but also patients with very severe disease and co-existing significant cardiovascular illness. Approximately 10 percent of the population were elderly (>75 years), 65 percent were classified as being high-risk cardiovascular patients and more than 40 percent were taking long acting bronchodilator therapy.
SUN-101 (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator delivered via the innovative, proprietary investigational eFlow® nebulizer closed system. SUN-101/eFlow® is currently in development as a nebulized treatment for patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD). The investigational combined product, consisting of SUN-101 and the eFlow® nebulizer closed system which has been optimized for SUN-101 delivery, has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of COPD.
Chronic obstructive pulmonary disease, also known as COPD, includes chronic bronchitis and emphysema, and is a progressive respiratory disease that causes worsening obstruction to airflow in the lungs over time.1 Approximately 15.7 million adults in the U.S. report that they have been diagnosed with COPD.2 It is estimated that several million more adults have undiagnosed COPD.3 COPD is responsible for over 120,000 deaths per year, making it the third leading cause of death in the U.S.3 COPD develops slowly and the symptoms often worsen over time, potentially limiting the ability to perform routine activities.1 Symptoms of COPD include constant coughing, wheezing, shortness of breath, excess production of mucus in the lungs, the inability to breathe deeply and the feeling of being unable to breathe.3
About Sunovion Pharmaceuticals Inc. (Sunovion)
Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovion’s spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. The Company has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological, and respiratory conditions. Sunovion’s track record of discovery, development and commercialization of important therapies has included Brovana® (arformoterol tartrate), Latuda® (lurasidone HCI), and most recently Aptiom® (eslicarbazepine acetate).
Headquartered in Marlborough, Mass. Sunovion is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Europe Ltd., based in London, England, and Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional information can be found on the Company’s web sites: www.sunovion.com, www.sunovion.eu and www.sunovion.ca. Connect with Sunovion on Twitter @Sunovion and LinkedIn.
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is a top-ten listed pharmaceutical company in Japan. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the Psychiatry & Neurology area and the Oncology area, which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has about 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at www.ds-pharma.com.
BROVANA is a registered trademark of Sunovion Pharmaceuticals Inc.
LATUDA is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd.
APTIOM is used under license from BIAL.
eFlow® is a registered trademark of PARI GmbH.
Spiriva® is a registered trademark of Boehringer Ingelheim Pharma GMBH & Co KG.
HandiHaler® is a registered trademark of Boehringer Ingelheim Pharma GMBH & Co KG.
Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd. © 2016 Sunovion Pharmaceuticals Inc.
For a copy of this release, visit Sunovion's web site at www.sunovion.com
1 National Heart, Lung and Blood Institute. What Is COPD? Available at http://www.nhlbi.nih.gov/health/health-topics/topics/copd/. Accessed: March 2, 2016
2 MMWR: Morbidity and Mortality Weekly Report. Employment and Activity Limitations Among Adults with Chronic Obstructive Pulmonary Disease - United States, 2013. March 27, 2015; 64(11). Available at http://www.cdc.gov/mmwr/
3 National Heart, Lung, and Blood Institute. "What is COPD?" Available at: http://www.nhlbi.nih.gov/health/educational/copd/what-is-copd/index.htm. Accessed: March 2, 2016