The U.S. Food and Drug Administration (FDA) has accepted for review Sunovion’s new drug application (NDA) for its SUN-101/eFlow system as a long-term maintenance therapy for airflow obstruction in adults with chronic obstructive pulmonary disease (COPD).
“SUN-101/eFlow demonstrates Sunovion’s commitment to delivering innovative therapies for patients with COPD,” Dr. Antony Loebel, MD, Sunovion executive vice president and chief medical officer, said in a press release.
“If approved, SUN-101/eFlow would be the first nebulized LAMA [long-acting muscarinic antagonists] for patients with COPD. We look forward to working with the FDA as we seek to gain approval of this innovative drug-device combination and further address the needs of patients with this debilitating condition,” said Loebel, also head of global clinical development for Sumitomo Dainippon Pharma Group.
SUN-101 (glycopyrrolate) is dispensed using PARI Pharma’s investigational and proprietary nebulizer system called eFlow.
“The way a medication for COPD is delivered is an important consideration,” said Dr. Gary Ferguson, from the Pulmonary Research Institute of Southeast Michigan in Livonia.
“By combining glycopyrrolate, a proven therapeutic option for COPD, with an advanced, handheld nebulizer delivery system designed to reduce the amount of time required for a treatment, SUN-101/eFlow has the potential to be a valuable alternative therapeutic option for patients who suffer from COPD,” Ferguson said.
The NDA submission was based on encouraging data from the GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) program that comprised three randomized Phase 3 clinical trials (GOLDEN 3, 4, and 5) evaluating the effectiveness and safety of the SUN-101/eFlow system.
The 12-week randomized, double-blind, placebo-controlled GOLDEN-3 (NCT02347761) and GOLDEN-4 (NCT02347774) trials compared SUN-101/eFlow with a placebo in adults with moderate-to-very severe COPD.
In May, Lung Disease News reported that both trials met their primary endpoints, with statistically significant changes from baseline in forced expiratory volume in one second (FEV1; a lung function measure) observed for both the 25 mcg and 50 mcg dose of SUN-101/eFlow, compared to a placebo. The treatment was well tolerated with no major adverse events reported.
The 48-week GOLDEN-5 (NCT02276222) trial assessed the long term safety and tolerability of twice-daily SUN-101/eFlow (50 mcg) compared to once-daily Spiriva (tiotropium bromide .18 mcg) delivered by the HandiHaler device in adults with moderate-to-very severe COPD.
Results showed that SUN-101/eFlow was well-tolerated as a twice-daily maintenance therapy for bronchoconstriction, with a similar overall incidence of adverse events to standard of care. The incidence of major adverse cardiovascular events was similar to Spiriva.
According to the Prescription Drug User Fee Act, the FDA’s expected action date for the NDA is May 29, 2017.