Teva’s ProAir RespiClick granted FDA approval

JERUSALEM — The Food and Drug Administration has approved Teva Pharmaceutical’s ProAir RespiClick (albuterol sulfate) inhalation powder, the company announced on Wednesday. The inhaler is used to treat or prevent bronchospasm (asthma) in patients 12 years of age and older who have reversible obstructive airway disease. It’s also indicated to prevent exercise-induced bronchospasm in patients 12 years of age and older. Teva said it expects the product to be available to patients during second-quarter 2015.

 

“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,” said Dr. David Bernstein of the University of Cincinnati College of Medicine, Division of Immunology, Allergy and Rheumatology. “The approval of ProAir RespiClick is significant as it eliminates the need for hand-breath coordination during inhalation.”

 

The FDA’s approval was based on a program consisting of eight clinical trials that evaluated the inhaler’s safety and efficacy in both adults and adolescents who had asthma and EIB. The results showed the inhaler to be safe and effective with side effects consistent with ones seen with previous albuterol inhalers, Teva said, adding that the most commons adverse events in greater than 1% of patients (compared to placebo) were back pain, body aches and pains, upset stomach, sinus headache and urinary tract infection.