FDA Rejects Anaphylaxis Drug Again, Requires More Data
Adamis Pharmaceuticals announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the New Drug Application (NDA) for Epinephrine Injection USP 1:1000 0.3mg Pre-filled Single Dose Syringe (PFS) for the emergency treatment of acute anaphylaxis. The product was designed as a lower cost alternative to other auto-injectors on the market.
Adamis recently made improvements to the PFS in response to the original CRL issued by the FDA on March 27, 2015. Because of these changes, FDA is requiring the Company to expand its human factors study (patient usability) and reliability study (product stress testing) in order to support its approval. Epinephrine is considered the drug of choice for immediate administration in acute anaphylactic reactions to insect stings or bites, foods, drugs and other allergens, as well as idiopathic or exercised-induced anaphylaxis.
Adamis will work closely with the FDA to resolve the requirements for the NDA. The Company believes that it can finalize the study protocols and complete additional testing within a relatively short period of time. They expect to submit data back to the FDA in the second half of 2016.
For more information visit Adamispharmaceuticals.com.