FDA Approves Airsupra (Albuterol and Budesonide) Inhalation Aerosol for On-Demand Treatment of Bronchoconstriction and Asthma

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The FDA has approved Airsupra inhalation aerosol (albuterol budesonide), for use in the treatment of bronchoconstriction or prevention, and to reduce asthma attacks among asthmatics 18 years and older. Airsupra combines albuterol, a beta-2-adrenergic receptor agonist (and corticosteroid), with budesonide.

Airsupra, a combination of inhaled corticosteroid and short-acting -agonist, is the U.S.’s first product containing ICS approved as a reliever (rather that a controller) treatment for asthma.

Treatment works by relaxing the muscles and reducing inflammation in the lungs airways. This reduces the risk of severe attacks. Airsupra can be administered as two oral inhalations containing a combination albuterol 90mcg, budesonide (80mcg), and albuterol (180mcg).

A disease or condition

Asthma, a chronic condition, causes the airways in the lungs to be inflamed. Asthma attacks are characterized by coughing, wheezing and chest tightness. In the United States, asthma affects more than 24 million people. Asthma can have different symptoms for each person, and symptoms can also change over time.


MANDALA (NCT03769090), an randomized, double blind, multicenter trial, evaluated the efficacy and safety of Airsupra in patients with severe to moderate asthma. The patients were randomly assigned to either Airsupra 160 mcg/180 mcg, or albuterol 190 mcg. They were instructed to take the medication as needed to treat asthma symptoms. MANDALA is a variable length exacerbation trial in which patients were treated for at least 24 week.

The primary efficacy outcome was the time until the first severe asthma attack. This is defined as the onset or worsening of asthma symptoms requiring systemic steroids for atleast three days, or an emergency department visit resulting in systemic corticosteroids being used for atleast three days, or hospitalization due to asthma for atleast 24 hours.

Airsupra treatment in adult patients reduced the risk of severe asthma attacks by 28%, as measured by the time until the first attack.

Safety Information

Airsupra is most commonly associated with headaches, oral candidiasis (oral yeast infection), coughing, and difficulty in speaking. Airsupra should not be used by patients who are hypersensitive to albuterol or budesonide. No more than six doses (or 12 inhalations) should be taken in a 24 hour period. Use with caution if you have cardiovascular disorders, convulsive disorder, hyperthyroidism or diabetes mellitus.

Airsupra was given a standard evaluation for this indication.

Airsupra comes with a full prescribing guide that contains additional information about the risks.


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