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FDA approves ProAir RespiClick for treatment of acute asthma symptoms
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The FDA approved ProAir RespiClick for the treatment of bronchospasm in patients aged 12 years and older with reversible obstructive airway disease, according to a Teva Pharmaceuticals press release.
ProAir RespiClick (albuterol sulfate) is a breath-actuated, multi-dose, dry-powder, short-acting-beta-agonist inhaler.
The approval is based widely on results from eight clinical trials assessing the safety and efficacy of the drug in adults and adolescents with asthma and exercise-induced bronchospasm (EIB).
Adverse events were typical of what was previously seen in other albuterol inhalers. Common adverse events when compared with placebo included back pain, body aches and pains, upset stomach, sinus headache and urinary tract infection.
“ProAir RespiClick is the first and only breath-actuated, dry-powder rescue inhaler to be approved by the FDA for the treatment of acute asthma symptoms,” David I. Bernstein, MD, MA, of the University of Cincinnati College of Medicine, said in the release. “The approval of ProAir RespiClick is significant as it eliminates the need for hand-breath coordinating during inhalation.”
The drug was also approved for the prevention of EIB. Teva expects the drug to become available to patients sometime during the second quarter of 2015.