PARI Pharma's Investigational Closed eFlow Nebulizer System Used in Two Successful Phase 3 Clinical Studies Evaluating Sunovion's SUN-101 (glycopyrrolate) in People with Moderate-to-Very Severe Chronic Obstructive Pulmonary Disease (COPD)
STARNBERG, Germany, June 7, 2016 /PRNewswire/ -- PARI Pharma, a company focused on the development of advanced aerosol therapies using eFlow Technology, announces that its proprietary closed eFlow Technology device was used in two pivotal Phase 3 clinical trials for Sunovion's long acting muscarinic antagonist (LAMA) SUN-101 (glycopyrrolate) in people with moderate-to-very severe chronic obstructive pulmonary disease (COPD).
These two Phase 3 clinical trials led by Sunovion, which has an exclusive license for use of the Investigational Closed eFlow Nebulizer System with SUN-101, showed statistically significant change from baseline in trough forced expiratory volume in one second (FEV1) at week 12 for both the 25 mcg and 50 mcg twice-daily dose groups versus placebo.
"We chose the closed eFlow® nebulizer system to pair with SUN-101 because it represents a new type of nebulizer system which combines 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."
In contrast to other nebulizers with an open medication reservoir, PARI's Investigational Closed eFlow Technology device uses a proprietary blow-fill-seal vial inserted into the handset by the patient before each treatment. The vial is pierced as the cap of the handset is attached and the drug product flows to the perforated vibrating membrane for aerosolization. Like all drug-specific eFlow Technology nebulizers, this closed system provides delivery efficiency with no residual volume, silent operation and short treatment times. The device has demonstrated usability in five completed clinical trials with SUN-101 in which approx. 2,500 patients with COPD were included.
"The positive results of the pivotal clinical trials which used the closed eFlow Nebulizer System are a significant milestone for the eFlow Technology platform in a major indication like COPD," added Martin Knoch, President of PARI Pharma. "This product combines a nebulized drug and device and is designed to deliver the medication in two to three minutes compared to a standard jet nebulizer that typically takes up to 10 minutes."
eFlow Technology is the leading perforated vibrating membrane nebulizer technology and offers customized and optimized devices for its clients. For instance, the proprietary closed eFlow Technology device used with Sunovion's SUN-101 offers an innovative and unique approach to nebulization.
Three drug/device combinations utilizing eFlow Technology have obtained regulatory approval and are commercially available in major markets. eFlow Technology also has been licensed in 11 partnerships within the pharmaceutical industry and is used for many more drug/device combinations currently under development by PARI Pharma's partners. Regulatory approval and commercialization are carried out for the combination of drug and device.
SUN-101 (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator delivered via the innovative, proprietary closed investigational eFlow® nebulizer system. SUN-101/eFlow® is currently in development as a nebulized treatment for patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD). The investigational combined product, consisting of SUN-101 and the closed eFlow® nebulizer system which has been optimized for SUN-101 delivery, has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of COPD.
About PARI Pharma and eFlow® Technology
PARI Pharma is a world leader in the development of aerosol delivery devices optimized with drug products for nebulized treatments using its proprietary technologies and expertise. PARI's platform of nebulizer systems based on eFlow Technology incorporate a vibrating, perforated membrane. eFlow Technology devices are designed to significantly improve lower respiratory tract deposition and reduce the burden of treatment for patients with severe respiratory conditions. PARI Pharma, a PARI Medical Holding company, is located near Munich, Germany with a major presence in the United States. For additional information, please visit www.pari.com/pharma.
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SOURCE PARI Pharma