Sunovion submits NDA for SUN-101/eFlow to FDA for the treatment of patients with COPD

SUN-101/eFlow

If approved, SUN-101/eFlow will be the first nebulized long-acting muscarinic antagonist (LAMA) for the long-term, maintenance treatment of airflow obstruction in patients with COPD.

The submission is based on the positive results of the GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) clinical trials program, which evaluated the efficacy and safety of SUN-101 (glycopyrrolate), a nebulized long-acting muscarinic antagonist (LAMA) delivered via an innovative investigational eFlow nebulizer system (SUN-101/eFlow). The GOLDEN program included three Phase III clinical trials. GOLDEN-3 and GOLDEN-4 were Phase III, 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter efficacy and safety trials comparing SUN-101/eFlow with placebo in patients with moderate-to-very severe COPD. 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 patients with moderate-to-very severe COPD.

“Patients are at the heart of everything we do at Sunovion,” said Antony Loebel, Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “This is an important milestone for us and the larger respiratory community, as we continue our mission of pioneering innovative treatments and therapies for COPD patients, their caregivers and healthcare providers.”