Benzinga | Jun 9, 2021 07:34AM EDT

Adamis Announces FDA Has Has Accepted For Review Co.'s Resubmitted NDA For ZIMHI

Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's resubmitted New Drug Application (NDA) for ZIMHI(tm), which is its higher naloxone injection product candidate for the treatment of opioid overdose. Adamis received FDA correspondence relating to the Company's NDA, stating that the Agency had completed its filing review and had determined that the NDA was sufficiently complete to permit a substantive review. The FDA also provided a target action date under the Prescription Drug User Fee Act (PDUFA date) of November 12, 2021.



"We are pleased with the FDA's decision to accept for review our NDA for ZIMHI. I believe this underscores the need for additional treatment alternatives for narcotic overdose," said Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals. "We look forward to working collaboratively with the FDA during the review process to support the case for approval of ZIMHI."

About Naloxone and the Growing Crisis of Opioid Overdose

* Naloxone is an opioid antagonist used to treat narcotic overdoses and is generally considered the treatment of choice for immediate administration in instances of opioid overdose.

* Naloxone blocks or reverses effects of the opioid, including extreme drowsiness, slowed breathing and loss of consciousness.

* Common opioids include morphine, heroin, tramadol, oxycodone, hydrocodone and fentanyl.

* The number of deaths due to opioids has increased over 5X since 1999. According to statistics published by the Centers for Disease Control and Prevention. In the 12 months ending May 2020, drug overdoses resulted in approximately 81,000 deaths in the United States -- greater than approximately 220 deaths per day. Drug overdoses are now the leading cause of death for Americans under 50. The proliferation of more powerful synthetic opioids, such as fentanyl and its analogues, could result in future increases in the number of deaths resulting from opioid overdoses. Recent studies from 2013 to 2016 have revealed an approximately 87% increase in deaths associated with synthetic opioids, whereas death rates due to natural and semisynthetic opioids remained relatively stable. In response to this significant increase in synthetic opioid abuse, there have been published studies that suggest the current recommended doses of naloxone may be inadequate and frequent redosing is likely required. Repeat dosing of the commonly utilized dose of naloxone suggests the need for a higher dosage product.