Sunovion Pharmaceuticals Inc has revealed dose ranging results from a Phase 2, randomized, double-blind, placebo-controlled, parallel group study of SUN-101 (glycopyrrolate inhalation solution) delivered via the innovative, proprietary eFlow nebulizer system twice a day in patients with moderate-to-severe COPD.
All four doses (12.5 mcg, 25 mcg, 50 mcg, and 100 mcg) studied produced statistically and clinically significant changes in forced expiratory volume in one second (trough FEV1) in bronchodilation, which persisted throughout the 24-hour dosing interval to inform dose selection. Data were presented at the 2014 American College of Chest Physicians annual meeting (CHEST 2014) in Austin.
SUN-101 is a long-acting muscarinic antagonist (LAMA) bronchodilator in development for the treatment of COPD that will be delivered via the innovative, propriety eFlow nebulizer system. SUN-101 and the eFlow device are currently being investigated as a treatment option for COPD and have not been approved by the FDA. Studies evaluating the efficacy and safety of SUN-101 delivered via the eFlow nebulizer system for the treatment of COPD are ongoing.
This randomized, double-blind, placebo-controlled parallel group study enrolled 282 study participants between the ages of 42 and 75 with COPD and a baseline ? 30 percent and ? 70 percent forced expiratory volume in one second (FEV1) and ? 10 pack-year smoking history. Study participants were randomized to receive one of four doses of SUN-101 (12.5 mcg, 25 mcg, 50 mcg, 100 mcg) or placebo BID for 28 days, and were evaluated for change from baseline in morning trough FEV1 after 28 days of treatment.
All study participants receiving LABA or LAMA therapy had their treatment replaced with albuterol MDI as “rescue therapy.” Inhaled corticosteroids and roflumilast were continued throughout the study. The study was sponsored by Sunovion Respiratory Development Inc, a wholly-owned subsidiary of Sunovion Pharmaceuticals Inc.
“While the efficacy and safety of SUN-101 have yet to be established, the data from this dose-ranging study illustrates that SUN-101 may be a potential treatment option for patients with moderate-to-severe COPD,” said lead investigator Edward Kerwin, MD, Medical Director of the Clinical Research Institute in Southern Oregon. “It’s important to develop a nebulized long-acting muscarinic antagonist, which is not currently available, to ensure that patients have a variety of treatment options and can work with their healthcare provider to determine which treatments are most appropriate for them.”