Sunovion Pharmaceuticals has announced that the FDA has accepted for review the New Drug Application (NDA) for SUN-101 (glycopyrrolate), a nebulized long-acting muscarinic antagonist (LAMA), delivered via PARI’s innovative investigational eFlow closed system nebulizer, for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). The expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is May 29, 2017.
“SUN-101/eFlow demonstrates Sunovion’s commitment to delivering innovative therapies for patients with COPD,” said Antony Loebel, M.D., Executive vice president and chief medical officer at Sunovion, head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “If approved, SUN-101/eFlow would be the first nebulized LAMA 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.”
The innovative, proprietary eFlow nebulizer system, developed by PARI Pharma, is a unique closed system delivery device currently in development for the treatment of moderate-to-very severe COPD.
“The way a medication for COPD is delivered is an important consideration,” said Dr. Gary Ferguson, Pulmonary Research Institute of Southeast Michigan, Livonia, Michigan. “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.”
The NDA for SUN-101/eFlow is based on data from clinical trials in the GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) program, which included GOLDEN-3 and GOLDEN-4, two phase III, 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, efficacy and safety trials comparing SUN-101/eFlow with placebo in adults with moderate-to-very severe COPD. These two studies met their primary endpoints, showing that patients treated with SUN-101/eFlow demonstrated a statistically significant change from baseline in trough forced expiratory volume in one second (FEV1) at week 12 versus placebo. An additional study, GOLDEN-5, was a phase III, 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 and included the active comparator Spiriva (tiotropium bromide) delivered by the HandiHaler device.
While these data support the NDA filing which has been accepted by the FDA, acceptance of the NDA does not mean that SUN-101/eFlow will be approved by the FDA for the treatment of adults with COPD.