Sunovion Pharmaceuticals announced that it has filed a New Drug Application with the U.S. Food and Drug Administration (FDA), requesting that SUN-101 and eFlow be approved as a long-term maintenance treatment of airflow obstruction in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
SUN-101 (glycopyrrolate) is a long-acting muscarinic antagonist bronchodilator (LAMA) delivered using the eFlow nebulizer closed system.
The FDA submission was based on topline positive data from the GOLDEN clinical trial program, which assessed the safety and efficacy of SUN-101 and eFlow.
“This is an important milestone for us and the larger respiratory community,” Antony Loebel, MD, executive vice president and chief medical officer at Sunovion, said in a recent press release.
eFlow a portable, hand-held electronic nebulizer, developed by PARI Pharma, which utilizes a vibrating, perforated membrane to create an inhalable aerosol. It is designed to deliver the medication in two to three minutes (compared to 10 minutes from a standard nebulizer) from a proprietary drug vial inserted into the device.
The GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) program included three Phase 3 clinical trials: two 12-week, randomized, double-blind, and placebo-controlled efficacy and safety studies (GOLDEN-3 and GOLDEN-4), and GOLDEN-5 a 48-week, randomized and open-label safety trial. All three trials of SUN-101/eFlow therapy were conducted in adults with moderate to severe COPD.
Both GOLDEN 3 and 4 achieved their primary endpoint, meaning a statistically significant change from baseline in forced expiratory volume in one second (FEV1 — a lung function measurement) at week 12 for treatment groups versus placebo. Likewise, the long-term GOLDEN 5 study found that SUN-101/eFlow was well-tolerated as a twice-daily maintenance treatment for bronchoconstriction in COPD patients, and had a similar overall incidence of adverse events to standard of care treatment.
COPD is a chronic and progressive obstructive lung disease characterized by long-term poor airflow. Its main symptoms include shortness of breath and cough with sputum production. COPD affects more than 15 million adults in the U.S. and is the country’s third leading cause of death.