FDA approves two new asthma maintenance inhalers

The FDA has approved two new RespiClick maintenance inhalers for the treatment of asthma in patients aged 12 years and older, according to their manufacturer, Teva Pharmaceuticals.

The company stated that its products — ArmonAir RespiClick (fluticasone propionate inhalation powder) and AirDuo RespiClick (fluticasone propionate and salmeterol inhalation powder) — both contain medication delivered using the company’s RespiClick breath-activated, multi-dose dry powder inhaler, forgoing the need for hand-breath coordination during inhalation.

“Prescribing the lowest effective dose of a medication is a key clinical objective in the treatment of asthma. It’s equally important that patients use their asthma inhalers correctly to ensure medicine is reaching the lungs,” Lyndon Mansfield, MD, clinical professor of pediatrics, Paul Foster School of Medicine, El Paso, Texas, said in a press release. “With research indicating that a significant number of patients still do not properly use their metered-dose inhalers, I am pleased that more asthma treatments and strengths are now approved in a device that eliminates the need for hand-breath coordination during inhalation.”

According to the release, the fixed-dose combination AirDuo RespiClick is a corticosteroid, long-acting beta₂-adrenergic agonist with the same active ingredients as Advair. It was approved in 55/14 mcg, 113/14 mcg and 232/14 mcg strengths. ArmonAir RespiClick is an inhaled corticosteroid with the same active ingredient as Flovent and was approved in 55 mcg, 113 mcg, and 232 mcg strengths for the maintenance treatment of asthma as prophylactic therapy. Both products were approved to be taken as one inhalation, twice a day.

The most common adverse events associated with AirDuo RespiClick included nasopharyngitis, oral candidiasis, back pain, headache and cough. The most common adverse events for ArmonAir RespiClick were nasopharyngitis, upper respiratory infection, oral candidiasis, headache and cough.

“With these approvals, we now integrate both fixed-dose combination and monotherapy into our core, breath-activated RespiClick device,” Rob Koremans, MD, president and CEO of Global Specialty Machines, Teva Pharmaceutical, said in the release.

The company stated that both products are expected to be available by prescription in the U.S. later this year.

Disclosure: Koremans works for Teva Pharmaceutical; Healio Family Medicine was unable to determine Mansfield’s relevant financial disclosures prior to publication.

Further reading: http://ir.tevapharm.com/phoenix.zhtml?c=73925&p=irol-newsArticle&ID=2240540