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# FDA Accepts for Review Sunovion NDA for COPD Therapy
- URL: https://www.fdaweb.com/fda-accepts-for-review-sunovion-nda-for-copd-therapy/
- Published: 2016-10-13T12:00:00.000Z
- Updated: 2026-09-14T21:39:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137068

FDA has accepted for review a Sunovion Pharmaceuticals NDA for SUN-101 (glycopyrrolate), a nebulized long-acting muscarinic antagonist delivered using PARI’s Pharma’s eFlow closed system nebulizer for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). The agency has set a user fee review action date of 5/29/2017.

The submission is based on data from clinical trials in the GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) program, which included GOLDEN-3 and GOLDEN-4, two Phase 3, 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 studies met their primary endpoints, showing that patients treated with SUN-101/eFlow “demonstrated a statistically significant change from baseline in trough forced expiratory volume in one second (FEV1) at week 12 versus placebo,” the company says.