The CRL does not require Sunovion to conduct any additional clinical studies for the approval of SUN-101/eFlow.
Sunovion will work with the FDA to determine an appropriate path forward. We are confident in SUN-101/eFlow and are committed to bringing this innovative therapy to COPD patients in the U.S. as quickly as possible.
About SUN-101/eFlow
SUN-101 (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator delivered via the proprietary investigational eFlow closed system nebulizer. SUN-101/eFlow is currently in development as a nebulized treatment for patients with moderate-to-very-severe COPD.
The investigational combined product, consisting of SUN-101 and the investigational eFlow® closed system nebulizer, which has been optimized for SUN-101 delivery, has not been approved by the FDA for the treatment of COPD.
About COPD
Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or lung abnormalities usually caused by significant exposure to toxic particles or gases. The main risk factor for COPD is tobacco smoking, but other environmental exposures may contribute.
Approximately 15.7 million adults in the U.S. report that they have been diagnosed with COPD.2 It is estimated that several million more adults have undiagnosed COPD.3 COPD is responsible for over 120,000 deaths per year, making it the third leading cause of death in the U.S.2 COPD develops slowly and the symptoms often worsen over time, potentially limiting the ability to perform routine activities.
Symptoms of COPD include coughing, wheezing, shortness of breath, excess production of mucus in the lungs, the inability to breathe deeply and the feeling of being unable to breathe.4 The symptoms of COPD can be most severe during the night and early morning.
Morning symptoms can be associated with limitation of activities during the day, impaired health status and increased risk of exacerbation. Night-time symptoms disturb sleep, reduce sleep quality and, in the long term, may be associated with development or worsening of cardiovascular diseases, cognition, depression and increased mortality.