Adamis Pharmaceuticals Resubmits ZIMHI New Drug Application to FDA

SAN DIEGO, May 18, 2020 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced the resubmission of the Company’s New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for its ZIMHI (naloxone HCI Injection, USP) 5mg/0.5mL product candidate for the treatment of opioid overdose. The resubmission follows the company’s meeting with the agency in February and is intended to address the issues raised by the FDA in the agency’s November 2019 Complete Response Letter (“CRL”).

Adamis previously announced that it entered into an exclusive distribution and commercialization agreement with US WorldMeds, LLC (“USWM”) for commercial rights for the ZIMHI product candidate. Under the terms of the agreement, USWM obtained U.S. rights to commercialize and distribute the ZIMHI, if approved by the FDA, in exchange for an upfront payment and potential regulatory and commercial milestones totaling up to $26 million. Additionally, Adamis and USWM will share equally in the net profits, as defined in the agreement. Adamis has retained rights to commercialize the ZIMHI product outside the U.S. and may also continue to develop its injection platform for additional product candidates. Additional information concerning the agreement and the transaction is contained in a report on Form 8-K that has been filed by the company with the Securities and Exchange Commission.

Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “We have been encouraged by our interactions with the FDA following our CRL and are pleased to resubmit our ZIMHI NDA. Based on the feedback from our Type A meeting in February, we conducted additional product testing with the goal of addressing the Chemistry, Manufacturing and Controls deficiencies discussed in the CRL. I feel the additional data addresses all the issues raised in the November CRL and we hope the FDA can expedite its review. With the rapid increase in synthetic opioid related deaths and the persistence of widespread opioid addiction, we believe that there remains a need for a higher dose treatment option to help combat this crisis.”

About ZIMHI
ZIMHI is a high-dose naloxone injection product candidate intended for the treatment of opioid overdose. Naloxone is an opioid antagonist and is generally considered the drug of choice for immediate administration for opioid overdose. It works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness. Common opioids include morphine, heroin, tramadol, oxycodone, hydrocodone and fentanyl. According to statistics published by the Centers for Disease Control and Prevention (CDC) in 2018, drug overdoses resulted in approximately 67,000 deaths in the United States – greater than 185 deaths per day. Drug overdoses are now the leading cause of death for Americans under 50, and more powerful synthetic opioids, like fentanyl and its analogues, are responsible for the largest number of deaths from opioid overdoses. On May 11, 2020, Adamis announced it entered into an exclusive distribution and commercialization agreement with USWM for U.S. commercial rights for the ZIMHI product.