Epinephrine pre-filled syringe for anaphylaxis refiled with FDA- Adamis Pharmaceuticals

The FDA has accepted for review Adamis Pharmaceuticals New Drug Application for its Epinephrine Pre-filled Syringe product candidate for the emergency treatment of anaphylaxis. Filed on December 4, 2015, the resubmission was intended to address the issues raised by the FDA in the agency’s March 2015 Complete Response Letter. The FDA indicated that it considered the resubmission to be a complete, class 2 response to the CRL, and provided an agency new action date of June 4, 2016.

The substance of the CRL related to the Chemistry, Manufacturing and Controls section, or more specifically, the volume of dose delivered by the syringe, including the ability to deliver volume within the levels contained in the labeling claim and as required by the FDA. No other safety or efficacy issues were raised, and the NDA remained open until the issues could be resolved. Adamis took approximately five months to re-engineer the design of the product, manufacture prototypes, and test the new design.

Comment: the Epinephrine Pre-filled 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.