A Phase 3 trial program of Sunovion Pharmaceutical’s SUN-101 glycopyrrolate inhalation solution for the treatment of moderate-to-very severe COPD has begun enrolling patients, the company announced. The program includes three studies expected to enroll about 2,340 COPD patients. SUN-101 is delivered using PARI’s eFlow nebulizer system and, if approved, would be the first nebulized LAMA for the treatment of COPD.
One of the trials, GOLDEN-5, an open label safety study comparing SUN-101 to Spiriva Handihaler actually began enrollment in October 2014. The other two studies, GOLDEN-3 and GOLDEN-4 will compare the safety and efficacy of twice-daily 25 µg SUN-101 and twice-daily 50 µg SUN-101 with placebo.
Sunovion Executive VP and Chief Medical Officer Antony Loebel commented, “We are committed to bringing innovative medications to patients with COPD and recognize the importance of developing a LAMA that can be delivered via a convenient and easy-to-use nebulizer. There is a high prevalence of undertreated COPD patients that could benefit from new nebulized treatment options. As a drug/device combination, SUN-101/eFlow has the potential to provide the effectiveness of a LAMA coupled with a portable electronic nebulizer.”
Sunovion acquired SUN-101, originally known as EP-101, when it acquired Elevation Pharmaceuticals in 2012. That company, which became a wholly owned subsidiary of Sunovion, now called Sunovion Respiratory Development Inc., is continuing the development program.
Read the Sunovion press release.
