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The FDA approved a pressured, metered-dose inhaler containing albuterol and budesonide (Airsupra) for treating adults with asthma, drugmaker .

The combination, formerly known as PT027, is specifically indicated for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in adults with asthma, and is the first product containing both an inhaled corticosteroid (budesonide) and a short-acting beta₂-adrenergic agonist (albuterol sulfate), according to the company.

Approval was based on results from the MANDALA and DENALI phase III trials.

In MANDALA, efficacy and safety of the combination inhaler were compared with use of albuterol alone in 3,132 adults, adolescents, and children with moderate to severe asthma.

Compared with albuterol rescue alone (180 mcg), the combination albuterol-budesonide inhaler (180 mcg and 160 mcg, respectively) resulted in a significant reduction in the risk of a severe exacerbation for adults and adolescents. Overall, 20.4% of these groups had a severe exacerbation while on the combination inhaler versus 26.2% for those on albuterol alone (HR 0.73, 95% CI 0.61-0.88, P<0.001).

In DENALI, a significant improvement in lung function, as measured by forced expiratory volume in one second (FEV₁), was observed in mild-to-moderate asthma patients randomized to the dual inhaler when compared with those assigned to one of its individual components or placebo.

"People with asthma are at risk of severe exacerbations regardless of their disease severity or level of control," said trial investigator Bradley Chipps, MD, of Capital Allergy & Respiratory Disease Center in Sacramento, California, in a statement. "Current albuterol rescue inhalers alleviate acute symptoms, but do not treat the underlying inflammation in asthma. The approval of Airsupra means that for the first time, adults with asthma in the U.S. have a rescue treatment to manage both their symptoms and the inflammatory nature of their disease."

In granting approval for use of the product only for adults, the FDA appeared to be following the recommendations of its Pulmonary-Allergy Drugs Advisory Committee, which in November gave near unanimous backing to the dual inhaler in the adult population, but were split when it came to adolescents and recommended against approval for children ages 4 to 11 years, groups where the data were mixed in subgroup analyses.

According to the company, the safety and tolerability of the dual inhaler is "consistent with the known profiles of the components," with the most common adverse events including headache, oral candidiasis, cough, and dysphonia.

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