An overview of glycopyrrolate/eFlow® CS in COPD

Abstract

COPD is highly prevalent in the US and globally, requiring new treatment strategies due to the high disease burden and increase in the aging population. Here, we profile the newly FDA-approved LONHALA MAGNAIR (glycopyrrolate [GLY]/eFlow® Closed System [CS]; 25 mcg twice daily), a nebulized long-acting muscarinic antagonist (LAMA) for the long-term maintenance treatment of COPD, including chronic bronchitis and/or emphysema. Areas covered: An overview of COPD and treatment landscape, focusing on GLY/eFlow CS, reviewing the published literature pertinent to the drug/device combination is reported. Expert commentary: GLY/eFlow CS consists of glycopyrrolate delivered via a novel electronic nebulizer and is the first nebulized LAMA to be approved by the FDA. GLY/eFlow CS has been studied in an extensive clinical development program, including phase II dose-ranging studies, two 12-week phase III studies demonstrating statistically significant and clinically important improvements in pulmonary function and patient-reported outcomes with a well-tolerated safety profile, and a 48-week phase III study highlighting the long-term safety of GLY/eFlow CS, along with long-term improvements in lung function and patient-reported outcomes. Additional studies are required to assess the impact of GLY/eFlow CS on COPD exacerbations, identify alternative uses of the eFlow CS nebulizer, and direct comparisons to other LAMAs.

<p>The Effect of Baseline Rescue Medication Use on Efficacy and Safety of Nebulized Glycopyrrolate Treatment in Patients with COPD from the GOLDEN 3 and 4 Studies</p>

“…In addition, treatment with GLY was generally well tolerated across all of the rescue medication subgroups. These data support the efficacy and safety of GLY 25 µg BID in patients with moderate-to-very-severe COPD, 7,11 independent of baseline rescue medication use. The findings of this analysis suggest that the frequency of rescue medication use may provide relevant information to clinicians related to COPD symptoms and control, especially when spirometry and symptom scale assessments are unavailable.…”

In Vitro Effect of Different Airflow Rates on the Aerosol Properties of Nebulized Glycopyrrolate in the eFlow® Closed System and Tiotropium Delivered in the HandiHaler®

“…Long-acting muscarinic antagonists (LAMAs) are bronchodilators that are widely used alone or in combination with long-acting b2-agonists, with or without inhaled corticosteroids. In this study, we compared the in vitro aerosol and drug-delivery properties of two LAMAs, delivered using different devices: tiotropium (TIO) delivered using the HandiHalerÒ DPI (18 lg powder in single-use capsules; SPIRIVAÒ Han-diHalerÒ, Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA), one of the most commonly prescribed DPIs, [24] and glycopyrrolate (GLY, 25 lg/ml in 1-ml single-use vials; LONHALAÒ, Sunovion Pharmaceuticals, Inc., Marlborough, MA, USA) delivered using the eFlowÒ Closed System (CS) (MAGNAIRÒ; PARI Pharma GmbH; Starnberg, Germany), a vibrating membrane nebulizer [25,26]. It is to be noted that the HandiHalerÒ is a high-resistance device and may not be suited for patients who cannot generate high PIF (e.g., in cases of COPD); [14] GLY delivered by the eFlowÒ CS may be an alternative for patients with low PIF who prefer a LAMA-based inhalation therapy.…”