The FDA today approved Teva's albuterol sulfate inhalation powder (Proair RespiClick).
The FDA today approved Teva’s albuterol sulfate inhalation powder (Proair RespiClick), a breath-actuated, multi-dose, dry-powder, short-acting beta-agonist (SABA) inhaler for the treatment or prevention of bronchospasm in patients aged 12 years and older with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm (EIB) in patients aged 12 years and older.
The agency based its nod on data from clinical trial which evaluated ProAir Respiclick’s safety and efficacy in adolescent aged 12 and older and adults with asthma and EIB. The researchers deemed the inhaler both safe and effective, with adverse events associated with the use of ProAir Respiclick consistent with those observed with other albuterol inhalers.
“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 David I. Bernstein, MD, of the University of Cincinnati College of Medicine, in a press release. “The approval of ProAir RespiClick is significant as it eliminates the need for hand-breath coordination during inhalation.”
The most common adverse events reported by trial participants treated with ProAir RespiClick include back pain, body aches and pains, upset stomach, sinus headache, and urinary tract infection. The use of the inhaler can also cause significant heart-related side effects, such as an increase in pulse or blood pressure.
“Teva is committed to optimizing respiratory therapies through the development of new delivery systems that address needs in the marketplace,” said Teva senior vice president Tushar Shah, MD, in a press release. “The approval of ProAir RespiClick is an important step forward in the progress of Teva's respiratory portfolio as it represents the first U.S. approval of our core, breath-actuated, dry-powder delivery device platform which we believe will bring additional benefit to patients.”
Teva plans to launch ProAir Respiclick in the United States during the second quarter of 2015, according to a press release.