THURSDAY, Jan. 12, 2023 (HealthDay News) -- Adults with asthma now have a new rescue medication to turn to after the U.S. Food and Drug Administration approved Airsupra on Wednesday. The drug is the first approved to combine albuterol and budesonide.
Airsupra is meant for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk for asthma attacks in patients with asthma aged 18 years and older. This medication is also the first approved in the United States to contain an inhaled corticosteroid as a reliever rather than as a controller of asthma symptoms.
Prior to the approval, the FDA evaluated the drug's effectiveness in reducing severe asthma attacks in a randomized, double-blind, controlled study with patients who had moderate-to-severe asthma. The patients in the study were randomly assigned to use either Airsupra or just albuterol on its own. Patients received treatment for at least 24 weeks.
The researchers looked at the time to the first severe asthma attack that required systemic corticosteroids for at least three days or an emergency room visit that led to taking steroids or hospitalization for at least 24 hours. Adult patients treated with Airsupra had a 28 percent reduction in the risk for a severe asthma attack compared with those using just the albuterol.
Airsupra is taken through two oral inhalations. Patients should not use more than six doses, a total of 12 inhalations, in a 24-hour period, according to the FDA. Those who have cardiovascular disorders, convulsive disorders, hyperthyroidism, diabetes, and ketoacidosis effects should use the drug with caution. Most common side effects for those taking Airsupra were headache, an oral yeast infection, cough, and difficulty speaking.
Approval of Airsupra was granted to Avillion and AstraZeneca.