Epinephrine Pre-filled Syringe (PFS) - single dose
The Epinephrine Pre-filled Syringe (PFS) (Epinephrine Injection USP 1:1000, 0.3mg Pre-Filled Single Dose Syringe) intends to compete as a simpler, more intuitive, low-cost therapeutic alternative to epinephrine auto injectors like the well-known brand EpiPen® in the anaphylaxis market. The Company filed its 505(b)(2) application with the FDA in May of 2014.
Addressable Market ~ $800 million
In the U.S., an estimated 5% of the population suffers from insect sting anaphylaxis, up to 6% are latex sensitive and up to 1.5% of adults and 5% of children under three years of age experience food related anaphylaxis. The number of prescriptions has grown annually as the risk of anaphylaxis has been more widely understood. Adamis also intends to introduce the Epinephrine PFS world-wide through licensing agreements.