FDA Approves 2 New Asthma Inhalers

Teva Pharmaceuticals recently announced FDA approval for 2 new RespiClick maintenance inhalers for the treatment of adults and adolescents with asthma.

AirDuo RespiClick (fluticasone propionate and salmeterol inhalation powder) and ArmonAir RespiClick (fluticasone propionate inhalation powder) deliver treatment through RespiClick breath-activated, multi-dose dry powder inhalers (MDPI), according to a press release.

The AirDuo RespiClick contains the same active ingredients as Adviar, according to Teva. This treatment is a combination of a corticosteroid plus a long-acting beta₂-adrenergic agonist, and is approved to treat patients aged 12 and older with asthma.

The ArmonAir RespiClick is an inhaled corticosteroid, and contains the same active ingredients as Flovent. The treatment is approved as a maintenance therapy in patients aged 12 and older with asthma.

“As a company on the forefront of developing inhaler technologies for people living with asthma, we are very pleased to now have two additional RespiClick-delivered medicines approved for adolescent and adult patients in the US,” said Michael Hayden, MD, PhD, president of Global R&D and chief scientific officer at Teva. “The expansion of our breath-activated product portfolio underscores Teva’s commitment to developing medicines that truly meet the needs of patients living with asthma and other respiratory diseases.”

Teva expects that these 2 inhalers will be available to patients in the United States later this year through a prescription.

The FDA approved the AirDuo RespiClick in 3 strenghts: 55/14 mcg, 113/14 mcg, and 232/14, and the ArmonAir RespiClick was also approved in 3 strengths: 55 mcg, 113 mcg, and 232 mcg. The treatments are both indicated to be administered twice per day as a maintenance asthma therapy.

“With these approvals, we now integrate both fixed dose combination and monotherapy into our core, breath-activated RespiClick device,” said Rob Koremans, MD, president and CEO of Global Specialty Medicines at Teva. “By expanding our RespiClick portfolio of breath-activated inhalers, we will provide physicians and their patients with additional treatment options in an inhaler device that does not require hand-breath coordination during inhalation.”

The new approvals for the RespiClick inhalers are supported with positive evidence from the clinical development program, which included three phase 3 clinical trials that evaluated the efficacy and safety of the treatments, according to Teva.

In double-blind studies, both treatments showed clinical benefits compared with placebo in terms of improved lung function at 12 weeks.

Common adverse reactions included nasopharyngitis, headache, cough, oral candidiasis, back pain (only AirDuo RespiClick), and upper respiratory tract infection (only ArmonAir RespiClick).

“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,” said Lyndon Mansfield, MD, clinical professor of Pediatrics at the Paul Foster School of Medicine, El Paso, TX. “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.”