Acton Pharmaceuticals, Inc. today announced that it has submitted to the U.S. Food and Drug Administration (FDA), a Manufacturing Supplement to the previously approved AEROSPAN Inhalation Aerosol NDA. Acton also announced that it has initiated commercial planning and market preparation activities for a product launch into the U.S. market targeted for mid-2011.
AEROSPAN is a hydrofluoroalkane (HFA) propelled inhaled corticosteroid for the treatment of asthma, which will compete in the $7 billion U.S. inhaled steroid market(1). The AEROSPAN New Drug Application (NDA) has been approved by the FDA and the rights were acquired by Acton in 2009 under a licensing agreement with Forest Laboratories, Inc. . Under the agreement, Acton assumed all marketing, sales and remaining manufacturing activities for AEROSPAN.
"We are very excited to achieve this important development milestone," said Patrick A. Noland, Executive Vice President, Technical Operations. "By applying our expertise in chemistry, scientific method, and state of the art analytical techniques, we are providing a Manufacturing Supplement to establish procedures that should bring our product to full commercial scale. We hope to receive a response from the FDA around the end of the first quarter in 2011."
AEROSPAN is the first HFA inhaled steroid to incorporate an integrated spacer device that assists patients in delivering their medication to the lung.
The company has initiated commercial scale up activities and plans to introduce AEROSPAN with its own specialty focused sales force. Acton is currently exploring co-promotion partnerships with primary care and pediatric focused pharmaceutical companies for the U.S. asthma market.
