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 market.
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
"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."
Acton Pharmaceuticals, Inc.