Adamis Pharmaceuticals Corporation announced the resubmission of the Company’s New Drug Application (NDA) to 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,
“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.”