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FDA Approves Aerospan (Flunisolide) Inhalation Aerosol for Asthma

Drug indicated for maintenance treatment in adults and children (Sept. 20)

Acton Pharmaceuticals, Inc., based in Marlborough, Mass., announced on September 20 that the FDA has approved the company’s Supplemental New Drug Application (sNDA) for Aerospan (flunisolide HFA, 80 mcg) Inhalation Aerosol, a hydrofluoroalkane (HFA) orally inhaled corticosteroid indicated for the maintenance treatment of asthma as a prophylactic therapy in adult and pediatric patients 6 years of age and older.

Acton is planning to launch the product in early 2013.

The Centers for Disease Control and Prevention (CDC) estimate that more than 24 million Americans have asthma, and of these, more than half experience an asthma attack each year. Annually, the disease is responsible for nearly two million emergency room visits and accounts for an estimated $11.5 billion in healthcare costs. When taken every day, maintenance inhalers can help prevent wheezing, coughing, and tightening of the airways, which cause shortness of breath and can be life-threatening.

Aerospan was developed with an integrated spacer device and has been studied in clinical trials involving more than 1,700 patients. The New Drug Application (NDA) for Aerospan was acquired by Acton in 2009 under a licensing agreement with Forest Laboratories, Inc., at which time Acton assumed all responsibilities associated with the development and commercialization of the product.

In a double-blind, parallel, placebo- and active-controlled clinical study of 669 adult and adolescent asthmatics aged 12 to 78 years previously treated with inhaled corticosteroids, Aerospan Inhalation Aerosol was administered for 12 weeks at a dosage of 80 mcg, 160 mcg, or 320 mcg twice-daily (BID). Both approved doses (160 mcg and 320 mcg) were significantly superior to placebo in the primary endpoint of FEV1 (a test of lung function that measures the amount of air forcefully exhaled in 1 second). Secondary endpoints of a.m. peak expiratory flow rate, a.m. and p.m. asthma symptoms, nocturnal awakenings requiring a beta-2 agonist, and as-needed use of inhaled beta-2 agonists showed differences from baseline favoring Aerospan over placebo.

Aerospan was also studied in 583 asthma patients aged 4 to 11 years, although the primary efficacy parameter — FEV1 — was evaluated only in a subpopulation of 513 patients aged 6 to 11 years. Aerospan Inhalation Aerosol was administered at 80 mcg or 160 mcg BID. Results demonstrated a statistically significant improvement in the change from baseline FEV1 for the 80-mcg and 160-mcg doses of Aerospan versus placebo. There was no added benefit for the 160-mcg dose over the 80-mcg dose.

Aerospan is not a bronchodilator and is not indicated for rapid relief of bronchospasm.

For more information, visit the Acton Pharmaceuticals Web site.

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