The FINANCIAL — Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) on April 1 announced that the U.S. Food and Drug Administration (FDA) has approved ProAir RespiClick (albuterol sulfate) inhalation powder, a breath-actuated, multi-dose, dry-powder, short-acting beta-agonist (SABA) inhaler for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease; and for the prevention of exercise-induced bronchospasm (EIB) in patients 12 years of age and older.
It is expected to become commercially available to patients during the second quarter of 2015, according to Teva.
“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.”
The approval was based on a comprehensive clinical development program consisting of eight clinical trials designed to evaluate the safety and efficacy of ProAir RespiClick in adults and adolescents (12 years of age and older) with asthma and EIB. Clinical trial results showed that ProAir RespiClick was both safe and effective with adverse events consistent with those seen with previous albuterol inhalers. The most common adverse events in greater than one percent of patients treated with ProAir RespiClick, compared to placebo, were back pain, body aches and pains, upset stomach, sinus headache, and urinary tract infection.
“Teva is committed to optimizing respiratory therapies through the development of new delivery systems that address needs in the marketplace,” said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. “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.”
Approved Uses
ProAir RespiClick (albuterol sulfate) Inhalation Powder is indicated in patients 12 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
Important Safety Information
Do not use ProAir RespiClick (albuterol sulfate) Inhalation Powder if you are allergic to albuterol sulfate, lactose, or milk proteins. Report any red, itchy bumps on your skin, swelling around the lips or eyes, or rash to your healthcare professional.
If your symptoms become significantly worse when you use ProAir RespiClick, seek medical attention immediately. This may indicate either a worsening of your asthma or a reaction to the medication. Either of these could be life-threatening.
Do not increase your dose or take extra doses of ProAir RespiClick without first talking to your healthcare professional.
Before using ProAir RespiClick, be sure to tell your healthcare professional if you have a heart, blood, thyroid or seizure disorder, high blood pressure, diabetes, are pregnant or planning to become pregnant, or are breastfeeding or planning to breastfeed.
ProAir RespiClick can cause significant heart-related side effects, such as an increase in pulse, blood pressure and/or related symptoms. If you have a heart condition, your healthcare professional will determine if ProAir RespiClick is right for you.
Make sure your healthcare professional knows all the medicines you are taking – especially other inhaled medicines, other asthma medicines, heart and blood pressure medicines and drugs that treat depression – because some medicines may interfere with how well your asthma medicines work.
Common side effects in patients taking ProAir RespiClick include back pain, body aches and pains, upset stomach, sinus headache, and urinary tract infection.
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