Acton Pharmaceuticals Announces U.S. Food and Drug Administration Approval for AEROSPAN® (Flunisolide HFA, 80 mcg) Inhalation Aerosol for Asthma

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Acton Pharmaceuticals, Inc. (Acton) announced today that the U.S. Food and Drug Administration (FDA) has approved the sNDA (Supplemental New Drug Application) 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. With this approval, Acton is now planning to launch AEROSPAN in early 2013 into the $8.3 billion U.S. inhaled steroid market¹.

“Preventing asthma attacks remains a significant hurdle in the treatment of asthma patients”

The Centers for Disease Control (CDC) estimates that more than 24 million Americans have asthma and of these, more than half have 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 health care costs. When taken every day, maintenance inhalers like AEROSPAN can help prevent the wheezing coughing, and tightening of the airways, which causes shortness of breath and can be life threatening.

“Preventing asthma attacks remains a significant hurdle in the treatment of asthma patients,” said William E. Berger, M.D., Clinical Professor, Department of Pediatrics, Division of Allergy and Immunology, University of California, Irvine. “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.”

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

John Simon, CEO of Acton said: “The FDA approval for AEROSPAN validates Acton’s commitment to bring forward important respiratory medicines for the millions of patients who suffer from asthma. We are very excited to have achieved this significant milestone, which is attributed to Acton’s sophisticated development team. Our ability to resolve complicated chemistry and manufacturing issues will now be leveraged to further develop our late-stage pipeline, including Nasacort HFA™.”

Daniel Kreisler, President of Acton added: “Acton anticipates commercial launch of AEROSPAN in the first quarter of 2013 as we build out our sales and marketing infrastructure and evaluate strategic partnerships. Our ongoing commercial preparations include building product inventory as well as finalizing the introduction of AEROSPAN to managed care plans and initiation of pre-launch marketing activities.”

AEROSPAN Clinical Data

In a double-blind, parallel, placebo-and active-controlled clinical study of 669 adult and adolescent asthmatics aged 12-78 previously treated with inhaled corticosteroids, AEROSPAN Inhalation Aerosol was given for twelve weeks at doses 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 one second). Secondary endpoints of AM peak expiratory flow rate, AM and PM asthma symptoms, nocturnal awakenings requiring a β2 agonist, and as needed use of inhaled β2 agonists showed differences from baseline favoring AEROSPAN over placebo.

Pediatric Patients with Asthma

AEROSPAN was studied in 583 asthma patients, four to 11 years of age, although the primary efficacy parameter, FEV₁, was evaluated only in the population of 513 patients six to 11 years of age. AEROSPAN Inhalation Aerosol was given at 80 mcg or 160 mcg BID. Results for the comparison versus placebo demonstrated a statistically significant improvement in change from baseline FEV₁ for the 80 mcg and 160 mcg doses of AEROSPAN, as there was no added benefit for the 160 mcg BID dose over the 80 mcg BID dose.

Important Safety Information

AEROSPAN Inhalation Aerosol is an orally inhaled corticosteroid indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 6 years of age and older. AEROSPAN is not a bronchodilator and is not indicated for rapid relief of bronchospasm.

In clinical trials, AEROSPAN was generally well tolerated. Particular care is needed in patients transferred from systemically active corticosteroids to AEROSPAN Inhalation Aerosol because deaths due to adrenal insufficiency have occurred in asthmatic patients transferred from systemically active corticosteroids to less systemically active inhaled corticosteroids. The most common adverse reactions (>3%) were headache, fever, allergic reaction, bacterial infection, pain and back pain, vomiting, dyspepsia, pharyngitis, rhinitis, cough, sinusitis, epistaxis, rash, and urinary tract infection.

Treatment with orally inhaled corticosteroids may lead to signs or symptoms of hypercorticism, suppression of hypothalamic-pituitary-adrenal (HPA) function and/or suppression of growth in children. Glaucoma, increased intraocular pressure and cataracts have been reported following the administration of inhaled corticosteroids.

About Acton

Acton is a specialty respiratory pharmaceutical company with expertise in development of aerosol inhalers and commercialization of respiratory products. Acton’s corporate headquarters are located in Marlborough, Massachusetts. To learn more about Acton, please visit our website at www.actonpharmaceuticals.com.

¹ Source: IMS NPA

AEROSPAN is a registered trademark of Forest Laboratories, Inc. Nasacort HFA is a trademark of Sanofi.