Sunovion Pharma Files NDA for COPD Drug

Sunovion Pharmaceuticals has filed an NDA for SUN-101/eFlow (glycopyrrolate), an investigational treatment for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease. Glycopyrrolate is a long-acting muscarinic antagonist (LAMA) bronchodilator delivered via the eFlow nebulizer closed system. The submission is based on data from the GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) clinical trial program. The primary endpoint, according to the company, was the change from baseline in trough forced expiratory volume in one second(FEV1) at week 12. Secondary endpoints included standardized change from baseline at week 12 in FEV1 area under the curve, change from baseline in trough forced vital capacity at week 12, change from baseline in health status measured by St. George’s Respiratory Questionnaire and change in rescue medication use.