Sunovion announced that the Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for SUN-101 (glycopyrrolate) delivered via the investigational eFlow closed system nebulizer, for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
Glycopyrrolate is a nebulized long-acting muscarinic antagonist (LAMA). If approved, SUN-101/eFlow would be the first nebulized LAMA drug for patients with COPD. The proprietary eFlow nebulizer system by PARI Pharma is a unique closed system delivery device under development for moderate-to-very severe COPD.
The NDA was based on data from the GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) clinical trials program that included two Phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, efficacy and safety trials (GOLDEN-3 and GOLDEN-4) comparing SUN-101/eFlow vs. placebo. The studies, which included adults with moderate-to-very severe COPD, met their primary endpoints, demonstrating that patients treated with SUN-101/eFlow had a statistically significant change from baseline in trough forced expiratory volume in one second (FEV1) at Week 12 vs. placebo.
GOLDEN-5 was a Phase 3, 48-week, randomized, open-label, active-controlled, parallel-group, multicenter safety trial that evaluated the long-term safety and tolerability of SUN-101/eFlow in adults with moderate-to-very severe COPD; an active comparator Spiriva Handihaler (tiotropium bromide; Boehringer Ingelheim) was included.
The expected action date under the Prescription Drug User Fee Act (PDUFA) is May 29, 2017.