Sunovion Pharmaceuticals, Inc., recently reported positive data on its Phase 3 clinical development program for SUN-101 (glycopyrrolate) for the treatment of moderate-to-severe chronic obstructive pulmonary disease (COPD).
SUN-101 is dispensed using PARI’s investigational and proprietary nebulizer system, called eFlow.
Two 12-week, randomized, double-blind, placebo-controlled and parallel-group, Phase 3 efficacy and safety trials (GOLDEN-3 and GOLDEN-4) compared SUN-101/eFlow to placebo in adults with moderate to very severe COPD. The trials met their primary endpoint, a change from baseline in forced expiratory volume in one second (FEV1; a measure of lung function) for both the 25 mcg and 50 mcg dose patient cohorts compared to placebo. The combined system (SUN-101/eFlow), of twice a day maintenance therapy for bronchoconstriction in COPD was also found to be well-tolerated by patients.
“The results from the GOLDEN-3 and GOLDEN-4 trials represent significant progress in our mission to deliver medicines to people with COPD,” Antony Loebel, MD, executive vice president and chief medical officer at Sunovion, and head of Global Clinical Development for Sumitomo Dainippon Pharma Group, said in a press release. “We look forward to filing an NDA [New Drug Application] and the possibility of making SUN-101/eFlow® available for patients.”
“Physicians are constantly seeking new innovations and treatment options to help patients with COPD manage their disease,” added Dr. Selwyn Spangenthal, the principal investigator for the GOLDEN-3 clinical trial. “SUN-101/eFlow®, as the first nebulized LAMA [long-acting muscarinic antagonist], could represent a significant breakthrough for patients.”
The eFlow rapid nebulizer system is a portable, hand-held electronic nebulizer, developed by PARI Pharma, which utilizes vibrating, perforated membrane to create an inhalable aerosol. The closed eFlow nebulizer system combined with SUN-101 is not approved yet by the FDA for the treatment of COPD.
“We chose the closed eFlow® nebulizer system to pair with SUN-101 because it represents a new type of nebulizer system which combines the attributes of both nebulizers and hand-held inhalers,” said Alistair Wheeler, head of Global Clinical Research, Respiratory Medicine and Biotherapeutics at Sunovion. “This system is designed to provide COPD patients who are in need of LAMA therapy with a handheld aerosolized inhalation option.”
Clinical results from the GOLDEN-3 and GOLDEN-4 trials will be presented at upcoming scientific conferences, according to the release. Sunovion is planning to file the New Drug Application with the U.S. Food and Drug Administration later this year.