Sunovion Pharmaceuticals announced positive data from its Phase 3 study of SUN-101 (glycopyrrolate), to treat people with moderate-to-very severe chronic obstructive pulmonary disease (COPD). SUN-101 is a nebulized long-acting muscarinic antagonist (LAMA) which is delivered using the ‘eFlow nebulizer system’, manufactured by respiratory company, PARI.
The Phase 3 study (GOLDEN-3 and GOLDEN-4) was a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial which lasted for 12-weeks. Each trial consisted of 653 and 641 people, respectively, who were randomized to SUN-101/eFlow 50mcg, SUN-101/eFlow 25mcg or placebo, twice daily.
Study results met the primary endpoints in both 50mcg and 25mcg groups, which was statistically significant change from baseline in trough forced expiratory volume in 1 second (FEV1) at week 12 versus placebo. In addition the SUN-101/eFlow was well-tolerated as a twice-daily treatment of bronchoconstriction in patients with COPD.
Data from the Phase 3 trials will support a forthcoming NDA for SUN-101/eFlow, which the company expects to submit within the fiscal year.