Two phase III trials of SUN 101/eFlow (glycopyrrolate) met primary endpoints in severe chronic obstructive pulmonary disease- Sunovion

Sunovion has announced positive results from the Phase III clinical trial program for SUN-101 (glycopyrrolate), a nebulized long-acting muscarinic antagonist (LAMA), delivered via PARI’s innovative investigational eFlow nebulizer system (SUN-101/eFlow), for people with moderate-to-very severe chronic obstructive pulmonary disease (COPD). The two clinical trials met their primary endpoints with a statistically significant change from baseline in trough forced expiratory volume in one second (FEV1) at Week 12 for both the 50 mcg and 25 mcg dose groups versus placebo. SUN-101/eFlow also was found to be well-tolerated as a twice-daily maintenance treatment of bronchoconstriction in patients with COPD.

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 adults with moderate-to-very severe COPD. The trials enrolled 653 and 641 people respectively who were at least 40 years old at 45 and 49 sites respectively in the United States. Sunovion will present data from the GOLDEN-3 and GOLDEN-4 studies at upcoming medical meetings. These data will also support a SUN-101/eFlow New Drug Application (NDA) package, which the Company expects to submit to the FDA during fiscal year 2016.