Sunovion's SUN-101 meets in COPD Phase IIIs

The Sunovion Pharmaceuticals Inc. unit of Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506) said glycopyrrolate ( SUN-101) delivered via the eFlow nebulizer system met the primary endpoint in the Phase III GOLDEN-3 and GOLDEN-4 trials to treat chronic obstructive pulmonary disease. The company expects to submit an NDA for the compound and nebulizer combination this fiscal year, which ends March 31, 2017.

Sunovion said twice-daily treatment with the long-acting muscarinic antagonist (LAMA) improved trough FEV-1 from baseline at 12 weeks in both studies, meeting the primary endpoint. It expects to release full results from the placebo-controlled trials at upcoming medical meetings. ...