Regulatory Affairs

Adamis’ Epinephrine pre-filled syringe secures FDA approval

Published 19 June 2017

Adamis Pharmaceuticals’ Epinephrine Injection, USP, 1:1000 (0.3 mg Pre-filled single dose syringe) (“PFS”) has secured approval from the US Food and Drug Administration (FDA) for the emergency treatment of allergic reactions (Type I) including anaphylaxis.

The FDA has also approved the PFS trade name of Symjepi.

Symjepi provides two single dose syringes of epinephrine (adrenaline), which is considered the drug of choice for immediate administration in acute anaphylactic reactions to insect stings or bites, allergic reaction to foods (such as nuts), drugs and other allergens, as well as idiopathic or exercise-induced anaphylaxis.

Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “We are very excited by this approval, and at the same time, are already preparing to submit our second NDA to the FDA.  This second submission is for the junior version of Symjepi.  We are committed to helping patients by providing them with additional therapeutic choices. 

"With an anticipated lower cost, small size and user-friendly design, we believe Symjepi could be an attractive option for a significant portion of both the retail (patient) and non-retail (professional) sectors of the epinephrine market. 

“We are currently in the process of exploring all of our commercialization options and in discussions with potential partners in order to facilitate broad patient access to this new epinephrine treatment option and to maximize the value of our important asset.  In the interim, we expect to build inventory levels in preparation for an anticipated launch in the second half of this year.” 

About Anaphylaxis

Anaphylaxis is a serious, sometimes life-threatening allergic reaction. The most common anaphylactic reactions are to foods, insect stings, medications and latex. According to information published by industry sources, up to 8% of U.S. children under the age of 18 have a food allergy, and approximately 38% of those with a food allergy have a history of severe reactions. Anaphylaxis requires immediate medical treatment, including an injection of epinephrine. 

The number of prescriptions for epinephrine products has grown annually, as the risk of anaphylaxis and allergic reactions have become more widely understood. The company estimates that sales of prescription epinephrine products in 2016 were at least $1 billion, based on industry data.



Source: Company Press Release