Adamis Pharmaceuticals Corp. recently resubmitted its new drug application to the U.S. Food and Drug Administration (FDA) for ZIMHI, a high-dose naloxone injection product candidate intended for the treatment of opioid overdose.
Adamis met with the FDA in February, and the resubmission is intended to address issues raised by the FDA in a letter in November.
“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 (letter),” Adamis President and CEO Dennis J. Carlo said. “I feel the additional data addresses all the issues raised in the November (letter), 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.”
Earlier this month, Adamis announced it had entered into an exclusive distribution and commercialization agreement with US WorldMeds for U.S. commercial rights for ZIMHI.
Under the agreement, US WorldMeds will commercialize and distribute the drug after it is approved by the FDA in exchange for an upfront payment and potential regulatory and commercial milestones of up to $26 million.