Adamis Pharma Submits NDA To FDA For Epinephrine Pre-Filled Syringe

(RTTNews) - Adamis Pharmaceuticals Corp. (ADMP) has submitted a New Drug Application or NDA to the U.S. Food and Drug Administration for its epinephrine pre-filled single dose syringe or PFS product. Particularly, the EPINEPHRINE INJECTION, USP, 1:1000 (0.3 mg Pre-filled single dose syringe) is designed for the emergency treatment of allergic reactions (Type I), including anaphylaxis.

Adamis' PFS provides a single dose of epinephrine (adrenaline), that is considered to be the drug of choice for immediate administration in acute anaphylactic reactions to insect stings or bites, allergic reaction to foods, drugs and other allergens, as well as idiopathic or exercised-induced anaphylaxis. Adamis' PFS is designed to be the low-cost, easy-to-use therapeutic alternative to existing epinephrine auto-injectors.

Adamis' President and CEO stated, "We feel this NDA submission represents a major milestone for Adamis. The epinephrine market is large and growing and we estimate auto-injector sales in the U.S. this year to approach one billion dollars. I believe our PFS could be an affordable substitute for the costly auto-injectors. These types of markets have proven to be cost sensitive and we expect epinephrine to be no different. Our PFS could allow Adamis to generate significant revenues and in time lead to profitability."

Anaphylaxis is a serious, sometimes life-threatening allergic reaction. The most common anaphylactic reactions are to foods, insect stings, medications and latex.