AstraZeneca announced that the Food and Drug Administration (FDA) has approved Bevespi Aerosphere (glycopyrrolate/formoterol fumarate) inhalation aerosol for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. 

Bevespi Aerosphere is the first long-acting muscarinic antagonist (LAMA)/long-acting beta-2 agonist (LABA) combination in a pressurized metered-dose inhaler to gain approval. In the airways, glycopyrrolate exhibits pharmacological effects through inhibition of the M3 receptor at the smooth muscle leading to bronchodilation. Inhaled formoterol fumarate acts locally in the lung as a bronchodilator.

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The FDA approval was based on data from the PINNACLE trial program that enrolled over 3,700 patients with moderate to very severe COPD.  In clinical studies, Bevespi Aerosphere provided statistically significant improvement in morning pre-dose forced expiratory volume in 1 second (FEV1) at 24 weeks (P<0.001) vs. its single components and placebo. It also demonstrated a significant improvement vs. placebo on peak FEV1 within 2 hours post-dose and rescue medication usage.

Bevespi Aerosphere utilizes the Company’s Co-Suspension Technology, which allows consistent delivery of one or more ingredients from a single pressurized metered-dose inhaler. The porous, low-density phospholipid particles are intended to help distribute drug crystals through the lungs for release at their sites of deposition.

Bevespi Aerosphere is available as a fixed-dose 9mcg/4.8mcg inhalation aerosol containing 120 inhalations each. 

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