ProAir RespiClick Seeks Pediatric Indication

The FDA could soon approve a pediatric use for Teva’s albuterol sulfate inhalation powder (ProAir RespiClick).

ProAir RespiClick is the only multi-dose, breath-activated short-acting beta-agonist (SABA) inhaler available in the United States.

It originally received FDA approval in March 2015 for the treatment and prevention of bronchospasm in patients ages 12 and older with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

Recently, Teva submitted a supplemental new drug application (sNDA) for the same uses of ProAir RespiClick in children ages 4 to 11. The FDA is now reviewing this sNDA and is expected to make its approval decision in April 2016.

“With millions of children living with asthma in the United States, it is important to provide this age group with a new option in rescue inhalers that does not require hand-breath coordination during inhalation,” stated Tushar Shah, senior vice president of Teva Global Respiratory Research and Development.

Common side effects associated with the product include back pain, body aches, upset stomach, and sinus headache. The use of the inhaler can also cause significant heart-related side effects, such as an increase in pulse or blood pressure.