Patients have shown time and again better reception and greater adherence to medications that are easy to use, so whether or not Adamis' drug is as effective as Mylan's, the real uphill battle will be convincing consumers to adopt syringes — especially in a drug that is typically used on and by children.
Adamis has the chance to gain some ground, however, given EpiPen's recent setbacks, which have included public and Congressional outcries over the drug's pricing and a recent recall that spanned across the U.S., Europe, Australia, Japan and New Zealand.
The WAC for Adrenaclick is $365, though consumers can get it for about $110 through CVS.
The first of those rejections was based on chemistry, manufacturing and controls (CMC) concerns, specifically whether the syringes could deliver the correct volume of medicine.
The second rejection called for expansions to two trials, data from which Adamis incorporated in its filing.