Sunovion has announced that the GOLDEN-3 and GOLDEN-4 Phase 3 clinical trials of SUN-101 glycopyrrolate inhalation solution for the treatment of moderate-to-very severe COPD both met their primary endpoints. SUN-101, delivered via the PARI eFlow handheld nebulizer, demonstrated statistically significant improvement in FEV1 versus placebo after 12 weeks for both the 50 µg and 25 µg doses. Sunovion acquired SUN-101, previously known as EP-101, when it acquired Elevation Pharmaceuticals in 2012.
The 12-week Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer (GOLDEN) trials were conducted at multiple sites in the United States with patients at least 40 years old. GOLDEN-3 enrolled 653 patients at 45 sites; GOLDEN-4 enrolled 641 patients at 49 sites. Sunovion announced the initiation of the trials, along with GOLDEN-5, in February 2015.
Sunovion Executive VP and Chief Medical Officer Antony Loebel commented, “The results from the trials represent significant progress in our mission to deliver medicines to people with COPD. We look forward to filing an NDA and the possibility of making SUN-101/eFlow available for patients.”
The company said that it expects to submit an NDA for SUN-101/eFlow by the end of fiscal year 2016.
Read the Sunovion press release.
