26 May 2017 - Sunovion Pharmaceuticals today announced that the U.S. FDA issued a complete response letter for the new drug application for SUN-101/eFlow (glycopyrrolate) for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema. 

The CRL does not require Sunovion to conduct any additional clinical studies for the approval of SUN-101/eFlow.

SUN-101 (glycopyrrolate) is a long-acting muscarinic antagonist bronchodilator delivered via the proprietary investigational eFlow closed system nebuliser. SUN-101/eFlow is currently in development as a nebulised treatment for patients with moderate-to-very-severe chronic obstructive pulmonary disease (COPD). The investigational combined product, consisting of SUN-101 and the investigational eFlow closed system nebuliser, which has been optimised for SUN-101 delivery, has not been approved by the FDA for the treatment of COPD.

Read Sunovion Pharmaceuticals press release