In reaction to news which broke during the session yesterday, biopharmaceutical company Adamis Pharma (ADMP 5.60, -0.15 -2.61%) announced it received approval for its EPINEPHRINE INJECTION, USP, 1:1000 (0.3 mg Pre-filled single dose syringe) from the US Food and Drug Administration for the emergency treatment of allergic reactions including anaphylaxis.
Per the approval, the FDA gave the PFS the trade name of Symjepi. 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.
This was essentially ADMP’s third time attempting to get Symjepi approved in a process which dates back to May 2014. ADMP submitted an NDA to the FDA for its ephinephrine pre-filled syringe back on May 29, 2014. About a year later, ADMP received a complete response letter from the FDA; the issues raised in the CRL pertained only to Chemistry, Manufacturing and Controls relating to the volume of dose delivered by the syringe, including the ability to deliver volume within the levels contained in the labeling claim and as required by the FDA.
Then in December of 2015, ADMP resubmitted the ephinephrine pre-filled syringe application to the FDA. About six months after that, the FDA issued a second CRL to ADMP, suggesting that the company expand its human factors study (patient usability) and reliability study (product stress testing), both of which were part of the final PFS NDA. The new formula was then submitted to the FDA again in December of 2016.
Which leads us up to today, the day after the PDUFA date for ADMP’s Symjepi. In a statement in conjunction with the FDA approval, ADMP management hinted that launch of the product should be a go for the second half of the year.
For those who may not be familiar with the Epinephrine injection, ADMP’s Symjepi is competition to Mylan’s (MYL 36.68, -0.30 -0.81%) EpiPen which as of recently has been the subject of pricing scrutiny.