The FDA has approved Adamis Pharmaceuticals’ epinephrine pre-filled syringe, Symjepi. The single dose medical device is indicated for the emergency treatment of Type I allergic reactions due to exposure to insect bites, foods and other allergens.
“We are very excited by this approval, and at the same time, are already preparing to submit our second NDA to the FDA,” said Dr. Dennis J. Carlo, President and CEO of Adamis. “This second submission is for the junior version of Symjepi.”
Mylan’s EpiPen currently holds the top position in the epinephrine market, however recent controversies surrounding the company’s pricing practices have prompted other companies to launch competitor products. Earlier this year, Mylan also issued a recall of select batches of potentially defective medical devices which were distributed through the US, New Zealand, Australia, Japan and Europe – an event that didn’t help to improve the public’s perception of Mylan.
While the Symjepi contains the same active ingredient as the EpiPen, it delivers the epinephrine through a manual syringe as opposed to an auto-injector device. This mode of administration has some wondering whether the Symjepi will be a true competitor to the best-selling EpiPen.
In 2015, approximately 3.6 million Americans were prescribed an EpiPen to treat accidental exposure to severe allergens. As many of these patients are children who are taught to administer the epinephrine themselves, a syringe could be significantly less user-friendly compared to an auto-injector.
While the cost of the Symjepi has yet to be announced, Adamis is betting that its competitive pricing will make it a desirable option for consumers. Their product is set to hit pharmacy shelves in the second half of this year.
“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,” said Dr. Dennis J. Carlo, President and CEO of Adamis. “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.”