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New Drug Application Submitted for Epinephrine Pre-Filled Syringe

Product would offer low-cost alternative to epinephrine auto injectors

A new drug application (NDA) has been submitted to the FDA for an epinephrine prefilled single-dose syringe (Adamis Pharmaceuticals).

Specifically, epinephrine injection, USP, 1:1000 (0.3-mg pre-filled single-dose syringe) is designed for the emergency treatment of type I allergic reactions, including anaphylaxis.

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

If approved, the product would compete as a low-cost therapeutic alternative to epinephrine auto injectors, such as EpiPen (Mylan).

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 has become more widely understood.

Sources: Pipeline Review; May 29, 2014; and Adamis Pharmaceuticals; 2013.

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