Positive Phase 3 Results Reported for Nebulized Glycopyrrolate in COPD

FDA submission scheduled for this year

Positive results have been reported from the phase 3 clinical trial program for SUN-101 (glycopyrrolate), a nebulized long-acting muscarinic antagonist (LAMA), delivered via the investigational eFlow nebulizer system (SUN-101/eFlow, Sunovion Pharmaceuticals), for patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer-3 (GOLDEN-3) and GOLDEN-4 were 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter efficacy and safety trials comparing SUN-101/eFlow with placebo in adults at least 40 years of age with moderate to very severe COPD. The studies enrolled 653 and 641 subjects, respectively, at sites in the United States. SUN-101/eFlow 50 mcg, SUN-101/eFlow 25 mcg, or placebo was administered twice daily. The primary endpoint was the change from baseline in trough forced expiratory volume in one second (FEV1) at week 12. Secondary endpoints included the change from baseline at week 12 in the FEVarea under the curve (AUC); the change from baseline in trough forced vital capacity (FVC) at week 12; the change from baseline in health status, as measured by the St. George’s Respiratory Questionnaire; and the change in rescue medication use. Safety was assessed by the number of treatment-emergent adverse events (TEAEs), serious adverse events, or major adverse cardiac events, and by the number and percentage of study participants who discontinued the studies because of TEAEs.

The two clinical trials met their primary endpoints, with a statistically significant change from baseline in trough FEV1 at week 12 for both the 50-mcg and 25-mcg dose groups compared with placebo. The combined product was also found to be well tolerated as a twice-daily maintenance treatment of bronchoconstriction in patients with COPD.

These findings will support a new drug application package for SUN-101/eFlow, which Sunovion expects to submit to the FDA during fiscal year 2016.

Source: Sunovion Pharmaceuticals; April 27, 2016.