Sunovion Pharmaceuticals has submitted a New Drug Application to the FDA for approval of Sun-101/eFlow, a maintenance treatment for 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.