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FDA Approves New Epinephrine Prefilled Syringe

The US Food and Drug Administration (FDA) has approved an epinephrine prefilled syringe (Symjepi, Adamis Pharmaceuticals) for the emergency treatment of allergic reactions (type I), including anaphylaxis, the company has announced.

"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," the company said in a news release.

Each Symjepi prefilled syringe contains 0.3 mg epinephrine.

"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," Dennis Carlo, president and CEO of Adamis, said in the release.

"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," he added.

The company said it is also preparing to submit a second new drug application to the FDA for a junior version of Symjepi.

According to the National Institute of Allergy and Infectious Diseases, food allergy affects approximately 5% of children and 4% of adults in the United States.

In March, the National Institutes of Health earmarked $42.7 million over 7 years to the Consortium of Food Allergy Research to continue their efforts to evaluate new approaches to treat food allergy.  

SOURCES:

FDA Approves New Epinephrine Prefilled Syringe. Medscape. June 16, 2017.


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