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Home » Directories » FDA Approved Drugs » Bevespi Aerosphere (glycopyrrolate and formoterol fumarate)

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Bevespi Aerosphere (glycopyrrolate and formoterol fumarate)

  • Profile

Profile

Contact Information

Contact: AstraZeneca
Website: https://www.bevespi.com/

Currently Enrolling Trials

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    General Information

    Bevespi Aerosphere is a combination of glycopyrrolate, an anticholinergic, and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA).

    Bevespi Aerosphere is specifically indicated 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 supplied as an aerosol for oral inhalation. The recommended dose for the maintenance treatment of COPD is two inhalations twice daily in the morning and in the evening. Two inhalations equal one dose.

    Mechanism of Action

    Bevespi Aerosphere is a combination of glycopyrrolate, an anticholinergic, and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA).

    Side Effects

    Adverse effects associated with the use of Bevespi Aerosphere may include, but are not limited to, the following:

    • urinary tract infection
    • cough

    Bevespi Aerosphere comes with the following Black Box warning: Long-acting beta2-adrenergic agonists (LABAs), such as formoterol fumarate, one of the active ingredients in Bevespi Aerosphere, increase the risk of asthma-related death. The safety and efficacy of Bevespi Aerosphere in patients with asthma have not been established. Bevespi Aerosphere is not indicated for the treatment of asthma.

    Clinical Trial Results

    The FDA approval of Bevespi Aerosphere was based on results of the PINNACLE phase III pivotal studies (PINNACLE 1, PINNACLE 2, and a safety extension study, PINNACLE 3) which included over 3,700 patients with moderate to very severe COPD. The studies demonstrated that Bevespi Aerosphere achieved statistically significant improvements in lung function as measured by change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at 24 weeks (p<0.001) versus its individual components (glycopyrrolate 9 mcg and formoterol fumarate 4.8 mcg) and placebo.

     

    Approval Date: 2016-04-01
    Company Name: AstraZeneca
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