APC-1000 – HFA Inhaled Oral Steroid

If approved, the APC-1000 by Adamis will be a hydrofluoroalkane (HFA) inhalable oral steroid for the treatment of asthma and COPD.

APC-1000 uses a well-known and accepted steroid combined with an HFA propellant that makes this product a pulmonary-metered dose inhaler (pMDI) with global potential. The company believes that product development risks for this product are low due to the widely accepted and documented clinical trial path to approval.

Beximco, an Adamis partner, has demonstrated the expertise and ability to manufacture complex HFA products, overcoming barriers to entry that have made it difficult for generic firms to develop such products. Beximco currently manufactures and sells a similar product in developing countries.

Potential Indication: Asthma/COPD

Asthma is a chronic lung disease that inflames and narrows the airways. Asthma causes recurring periods of wheezing, chest tightness, shortness of breath, and coughing. Asthma affects people of all ages, but it most often starts during childhood. In the United States, more than 25 million people are known to have asthma and about 7 million of these people are children.

Chronic obstructive pulmonary disease, or COPD, is a progressive disease that makes it difficult to breathe. COPD can cause coughing that produces large amounts of mucus, wheezing, shortness of breath, chest tightness, and other symptoms. Cigarette smoking is the leading cause of COPD. Long term exposure to other irritants—such as air pollution, chemical fumes, or dust—also may contribute to COPD.