Sunovion Pharmaceuticals Inc. recently announced the beginning of enrollment for its Phase 3 clinical trial plan for SUN-101 (glycopyrrolate) solution for inhalation to be delivered through the investigational eFlow®nebulizer system (SUN-101/eFlow®) from PARI Pharma GmbH. SUN-101/eFlow® is being assessed for maintenance of chronic obstructive pulmonary disease (COPD) using two doses per day to address bronchoconstriction. The drug is also being evaluated for its efficacy in emphysema and chronic bronchitis.
SUN-101/eFlow® is a nebulized long-acting muscarinic antagonist (LAMA) currently in Phase 3 of development. Phase 2 safety and efficacy results were delivered at the 2014 American College of Chest Physicians Annual Meeting (CHEST 2014) held in Austin, Texas. LAMAs can control COPD efficiently, however, nebulizer-delivered LAMAs have not been approved by the United States Food and Drug Administration (FDA).
“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,” said Antony Loebel, Sunovion’s representative.
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The clinical trial will include 3 different studies currently enrolling almost 2,340 adult patients with moderate to very severe COPD. Both GOLDEN-3 and GOLDEN-4, which began enrolling patients in February 2015, are double-blinded, randomized and placebo-controlled efficacy and safety studies comparing a two times per day administration of SUN-101/eFlow® 25 mcg and 50 mcg with placebo. GOLDEN-5 is a 48-week long-term open-label safety assessment that started enrolling patients in October 2014 and aims to compare the 50 mcg of SUN-101/eFlow®delivered two times per day with Spiriva® (tiotropium bromide) 18 mcg delivered one time per day through the HandiHaler® device.
“As the first company to introduce a long-acting nebulized maintenance medicine for COPD to the U.S. market in 2007, Sunovion continues to be a leader in this area with the current development program for SUN-101/eFlow®. Sunovion has a long-standing dedication to the COPD community, and in addition to our development of new treatment options, we take pride in our close and productive working relationships with the respiratory community,” said David Frawley, from Sunovion.