Adamis Pharmaceuticals announced yesterday they have submitted a prior approval supplement to the US Food and Drug Administration (FDA) for a pediatric version of their Symjepi™ device.
Symjepi is not an auto-injector per se, but a syringe prefilled with epinephrine that requires the person operating the device to press down on a plunger to administer the medication. Because of it’s simplicity, it is expected to be a much cheaper alternative to the auto-injectors on the market today but may be more appropriate for responders who will administer the device in emergencies. Symjepi was approved by the FDA in June.
The pediatric version will carry a 0.15mg dose appropriate for children 33-65 pounds, much like the pediatric versions of EpiPen, Auvi-Q, and the Adrenaclick Generic.
Said Dr Dennis Carlo, President and CEO of Adamis:
With this submission we are excited to take another step forward to provide this potentially life-saving treatment to a broader range of patients that are at risk of anaphylaxis.
I know there is great interest in the commercial plan for Symjepi. We are in confidential discussions with several potential partners. We remain committed to bring Symjepi to market and intend to announce our commercial plan once definitive arrangements have been finalized.