FDA approves AEROSPAN as asthma treatment

The FDA on Sept. 21 approved AEROSPAN (flunisolide hydrofluoroalkane, 80 mcg) Inhalation Aerosol for maintenance treatment of asthma, according to a press release.

The drug, developed by Acton Pharmaceuticals Inc., is an orally-inhaled corticosteroid with an integrated spacer device and is intended for use in adults and pediatric patients aged 6 years and older. Acton plans to release the drug during the first quarter of next year.

AEROSPAN received approval following results from clinical trials, including a 669-patient study including individuals aged 12-78 years and a trial incorporating 513 patients aged 6 to 11 years. Common side effects include headache, fever, allergic reaction, bacterial infection, dyspepsia, rhinitis, sinusitis and urinary tract infection, according to the release.

“Preventing asthma attacks remains a significant hurdle in the treatment of asthma patients,” William E. Berger, MD, clinical professor, Department of Pediatrics, Division of Allergy and Immunology at the University of California in Irvine, Calif., said in the release. “The FDA approval for AEROSPAN will provide patients with an effective new treatment option, and it’s exciting that physicians will be able to prescribe an inhaled steroid with a unique, built-in delivery system that is designed to make it easy for patients to inhale their aerosol medication.”