Sunovion Pharmaceuticals Inc has reported positive results from the Phase 3 clinical trial program for Sun-101 (glycopyrrolate), a nebulized long-acting muscarinic antagonist (LAMA), delivered via Pari’s investigational eFlow nebulizer system (Sun-101/eFlow), for people with moderate-to-very severe COPD.
The two clinical trials met their primary endpoints with a statistically significant change from baseline in trough forced expiratory volume in one second (FEV1) at Week 12 for both the 50 mcg and 25 mcg dose groups versus placebo. Sun-101/eFlow also was found to be well-tolerated as a twice-daily maintenance treatment of bronchoconstriction in patients with COPD.
“The results from the GOLDEN-3 and GOLDEN-4 trials represent significant progress in our mission to deliver medicines to people with COPD,” said Antony Loebel, MD, Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “We look forward to filing an NDA 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,” said Dr Selwyn Spangenthal, American Health Research and Principal Investigator for the GOLDEN-3 clinical trial. “Sun-101/eFlow, as the first nebulized LAMA, could represent a significant breakthrough for patients.”
“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 Pharmaceuticals. “This system is designed to provide COPD patients who are in need of LAMA therapy with a handheld aerosolized inhalation option.”
The innovative, proprietary, closed eFlow nebulizer system, developed by Pari Pharma GmbH, is a unique type of closed system delivery device currently in development for the treatment of moderate-to-very severe COPD. It is a portable, hand-held, electronic nebulizer system that uses a vibrating, perforated membrane to generate an inhalable aerosol. The closed eFlow nebulizer system is designed to deliver the medication in two to three minutes from a distinctive proprietary drug vial inserted into the device. A standard jet nebulizer typically takes up to 10 minutes. The investigational combined product, consisting of SUN-101 and the closed eFlow nebulizer system, has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of COPD.
Sunovion will present data from the GOLDEN-3 and GOLDEN-4 studies at upcoming medical meetings. These data will also support a Sun-101/eFlow New Drug Application (NDA) package, which the company expects to submit to the FDA during fiscal year 2016.
When does this come out?
What they don’t tell you is that because this is not a standard nebulizer solution, but uses a semi-disposable nebulizer, the medication is NOT covered under Medicare Part B, but falls under Part D. Under Part B, if you have a Medicare Supplement, you pay little or nothing for nebulizer meds. However, under Part D, since this med is not on most insurance company’s formulary, retail cost is $3000 for a 90 day supply!