New Rescue Inhaler Approved

The US Food and Drug Administration (FDA)Wednesday announced the approval of Teva’s albuterol sulfate inhalation powder (ProairRespiClick), a breath-actuated, multi-dose, dry-powder, short-acting beta-agonist (SABA) inhaler for treating or preventing bronchospasm in patients 12 years and older suffering from reversible obstructive airway disease and for preventing exercise-induced bronchospasm (EIB) in patients 12 years and older.

The approval was based primarily on data from a clinical trial that evaluated ProAir RespiClick’s safety and efficacy in adolescents 12 years and older as well as in adults with asthma and EIB.

They noted adverse events associated with ProAir RespiClick use — back pain, body aches and pains, upset stomach, sinus headache, and urinary tract infection – were consistent with those previously observed with other albuterol inhalers. Additionally, the inhalercould potentially cause significant heart-related side effects, such as an increase in pulse or blood pressure.

“ProAirRespiClick 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. “The approval of ProAir RespiClick is significant as it eliminates the need for hand-breath coordination during inhalation.”

Tushar Shah, MD, Teva Senior Vice President, said in a press release, “Teva is committed to optimizing respiratory therapies through the development of new delivery systems that address needs in the marketplace.”

Shah continued, “The approval of ProAir RespiClick is an important step forward in the progress of Teva's respiratory portfolio as it represents the first US approval of our core, breath-actuated, dry-powder delivery device platform which we believe will bring additional benefit to patients.”

Plans to launch ProAir Respiclick in the US during the second quarter of 2015 are underway.