Bevespi Aerosphere (glycopyrrolate and formoterol fumarate)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved April 2016

Specific Treatments:

chronic obstructive pulmonary disease

Therapeutic Areas

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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.

Clinical Results

FDA Approval

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.

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.

Mechanism of Action

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

Additional Information

For additional information regarding Bevespi Aerosphere or COPD, please visit https://www.bevespiaerosphere.com/