Adamis Pharmaceuticals Corporation announced that after the close of the stock markets on June 3, 2016 it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) Epinephrine Injection USP 1:1000 0.3mg Pre-filled Single Dose Syringe (PFS) product. PFS is for the emergency treatment of acute anaphylaxis, which is a severe allergic reaction. A CRL is issued by the FDA's Center for Drug Evaluation and Research when it has
Because of the improvements that were made to the PFS in response to the FDA’s original CRL dated March 27, 2015, the FDA indicated that in order to support approval of the product, the Company must expand its human factors study (patient usability) and reliability study (product stress testing), both of which were part of the final PFS NDA. The Company believes that it can finalize the study protocols with the FDA and complete the additional testing within a relatively short period of time at an immaterial cost, and submit the data back to the FDA sometime in the second half of 2016. It should be noted that the Company has successfully completed the “volume delivery” issue that was associated with the initial CRL.The FDA has indicated that the NDA will remain open until these issues are resolved.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “We look forward to working with the FDA to resolve the remaining issues. Our goal is to submit the protocols for these studies to the FDA within a matter of weeks and begin the testing as soon as we receive their feedback. We are confident that we can deliver all of the data requested by FDA and will continue to work closely with the agency to facilitate their continued review of our NDA. Adamis remains committed to bringing the epinephrine PFS to market.”
