Alternative to EpiPen Approved by FDA - Drug Discovery and Development

A less-expensive allergy shot may be available at your local pharmacy later this year.

The U.S. Food and Drug Administration (FDA) approved Adamis Pharmaceutical’s EPINEPHRINE INJECTION, USP, 1:1000 (0.3 mg Pre-filled single dose syringe) for the emergency treatment of allergic reactions, including anaphylaxis.

The FDA has also approved the company’s trade name of Symjepi.

Like EpiPen, Symjepi will provide two pre-filled single doses of epinephrine, indicated 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.

Unlike EpiPen, the device is a syringe, not an auto-injector, making it easier to use, according to the company.

Also setting it apart from the competition: Symjepi is smaller, and less expensive. Adamis has not set an exact price yet, but is anticipating a lower price point for the life-saving drug—even lower than the price of generic EpiPens.

“We are very excited by this approval, and at the same time, are already preparing to submit our second NDA to the FDA,” said Dennis J. Carlo, President and CEO of Adamis in a press statement. The second submission is for the junior version of Symjepi.

“We are committed to helping patients by providing them with additional therapeutic choices,” said Carlo. “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.

The company is anticipating launch of the drug in the second half of this year.