Study of SUN-101/eFlow demostrates improvement of lung function for COPD patients.-Sunovion Pharma.

Sunovion Pharmaceuticals presented new secondary analyses of safety and efficacy data from the Phase III GOLDEN clinical study program for SUN-101/eFlow (glycopyrrolate) which showed that pooled data analyses of the GOLDEN-3, GOLDEN-4 and GOLDEN-5 studies showed the investigative, nebulized, long-acting muscarinic antagonist (LAMA) improved lung function and was well tolerated in clinical trial populations with moderate-to-very-severe chronic obstructive pulmonary disease (COPD), including people with cardiovascular (CV) risk factors, on background long-acting beta2 agonist (LABA) therapy and lower peak inspiratory flow rates (PIFR), as well as individuals 65 years of age and older.

A secondary analysis of GOLDEN-3 and GOLDEN-4 showed that nebulized SUN-101/eFlow (25 mcg and 50 mcg twice daily) resulted in statistical and clinically important improvements in lung function over the 12 week treatment period and was well tolerated in subgroups with baseline lung function of below 50 percent and at least 50 percent predicted normal and in age ranges of less than 65 years, of at least 65 years and of at least 75 years as measured by trough FEV1. Data were presented at the American College of Chest Physicians (CHEST) Annual Meeting.

Comment: In June 2017, Sunovion announced that the FDA accepted for review the resubmission of the New Drug Application for SUN-101/eFlow for the long-term, maintenance treatment of airflow obstruction in people with COPD, including chronic bronchitis and/or emphysema. If approved, SUN-101/eFlow would be the first nebulized LAMA approved for the treatment of COPD in the U.S., as well as the first use of an eFlow technology nebulizer to treat COPD. The expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is December 15, 2017.