Sunovion Pharmaceuticals has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA), seeking approval of its SUN-101/eFlow technology as a long-term maintenance treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).
SUN-101, a nebulized long-acting muscarinic antagonist, is dispensed using PARI Pharma’s investigational and proprietary nebulizer system, called eFlow. The eFlow rapid nebulizer is a portable and hand-held electronic nebulizer that utilizes a vibrating, perforated membrane to create an inhalable aerosol.
The NDA submission was based on positive data from the GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer) clinical trial program, which included three Phase 3 studies (GOLDEN 3, 4 and 5) assessing the safety and the efficacy of SUN-101/eFlow system.
“This is an important milestone for us and the larger respiratory community, as we continue our mission of pioneering innovative treatments and therapies for COPD patients, their caregivers and healthcare providers,” Dr. Antony Loebel, MD, executive vice president and chief medical officer at Sunovion, and head of global clinical development for Sumitomo Dainippon Pharma Group, said in a press release.
GOLDEN-3 and GOLDEN-4 were 12-week double-blind, placebo-controlled safety and efficacy trials comparing SUN-101/eFlow to a placebo in adults with moderate to severe COPD.
The trials met their primary endpoint, a change from baseline in forced expiratory volume in one second (FEV1; a measure of lung function) for both the 25 mcg and 50 mcg dose in patient cohorts compared to a placebo. The twice-daily combined SUN-101/eFlow system maintenance therapy for bronchoconstriction in COPD was also found to be well-tolerated by patients. Safety was assessed with the number of treatment-emergent adverse events, serious adverse events or major adverse cardiac events, along with the number of participants who discontinued the study due to adverse events.
“The results from the GOLDEN-3 and GOLDEN-4 trials represent significant progress in our mission to deliver medicines to people with COPD,” Loebel said in a release announcing the trials’ positive results, reported by Lung Disease News in May.
GOLDEN-5 was a 48-week Phase 3 trial that evaluated the long-term safety and tolerability of 50 mcg SUN-101/eFlow twice-daily, compared to 18 mcg of Spiriva (tiotropium bromide) once-daily delivered by the HandiHaler device, in adults with moderate to very severe COPD.
A total of 1,087 patients were enrolled at 111 research sites in Europe and the U.S. Its primary end points included the number of participants with treatment-emergent adverse events, the number of patients with serious adverse events, and the number of patients who discontinued the study due to adverse events.
Secondary endpoints included the assessment of the mean change from baseline throughout 48 weeks in forced expiratory volume in one second (FEV1) and the number and percentage of patients with major adverse cardiac events.