Sunovion announced positive findings from the GOLDEN-5 safety study evaluating SUN-101 (glycopyrrolate) delivered via an investigational nebulizer system (SUN-101/eFlow) for the treatment of moderate-to-very severe chronic obstructive pulmonary disease (COPD).
GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer)-5 was a 48-week, multicenter, randomized, open-label, active-controlled, parallel-group Phase 3 trial which evaluated the long-term safety and tolerability of SUN-101/eFlow 50mcg twice daily vs. Spiriva(tiotropium bromide; Boehringer Ingelheim) 18mcg once daily in 1,087 COPD patients. The primary safety endpoints were the number and percentage of patients: 1) with treatment-emergent adverse events (TEAE); 2) with treatment-emergent serious adverse events (SAE); and 3) who discontinued the study due to TEAEs. Secondary endpoints included the mean change from baseline over 48 weeks in trough forced expiratory volume in one second (FEV1) for all patients and the number and percentage of patients with major adverse cardiovascular events (MACE).
Results from the study showed that maintenance treatment with SUN-101/eFlow twice daily was well-tolerated as a bronchodilator in patients with moderate-to-very severe COPD. The overall incidence of adverse events was similar to those of standard of care therapies. Additionally, the incidence of MACE was similar to the active comparator, Spiriva. The company plans to present detailed study data from the GOLDEN-5 study at an upcoming medical meeting.
Using results from this safety trial, along with data from various Phase 3 efficacy studies, Sunovion anticipates a New Drug Application (NDA) submission to the FDA for SUN-101/eFlowsome time this year.
SUN-101 (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator delivered via the innovative, proprietary eFlow nebulizer closed system. Developed by PARI Pharma, eFlow is a portable, hand-held, electronic nebulizer system designed to deliver an entire dose of medication in 2–3 minutes, much faster than the standard jet nebulizer that typically takes up to 10 minutes.
For more information call (800) 739-0565 or visit Sunovion.com.