NAPSR News: FDA Approves Teva’s ProAir® RespiClick

WASHINGTON - April 1, 2015 - PRLog -- The U.S. Food and Drug Administration (FDA) has approved Teva Pharmaceutical's ProAir® RespiClick inhalation powder to treat or prevent bronchospasm in patients 12 years of age and older with reversible obstructive airway disease. Additional indications also include preventing exercise-induced bronchospasm (EIB) in patients 12 years and older.

“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 I. 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.”

Approval was based on eight clinical trials which were a part of a comprehensive clinical development program to evaluate the treatment’s safety and efficacy profile in adults and adolescents (12 years of age and older) with asthma and EIB. Clinical data showed ProAir® RespiClick was consistently both safe and effective comparable to previous albuterol inhalers. Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development stated, “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 anticipates that ProAir® RespiClick will be commercially available to patients during the second quarter of 2015.

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