Adamis Pharmaceuticals Strengthens Patent Portfolio for Its Naloxone Product Candidate

SAN DIEGO, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) ("Company") today announced that it recently received a notice that one of its patent applications relating to its ZIMHI high dose naloxone injection product candidate, intended for the treatment of opioid overdose, was allowed by the U.S. Patent and Trademark Office. The allowed claims describe a naloxone composition at a dose greater than or equal to five milligrams configured for administration as an injection. The company believes this patent should protect and strengthen the existing intellectual property associated with the product candidate.

According to new data from the U.S. Centers for Disease Control and Prevention (“CDC”), deaths from drugs overdoses have substantially accelerated amid the COVID-19 pandemic. The CDC data indicates that more than 81,000 drug overdose fatalities occurred in the U.S. between June 2019 and May 2020. This is the highest number of overdose deaths ever recorded in a year-long period. These numbers are expected to increase.

Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, added, “The current opioid epidemic seems to be fueled by the more potent synthetic opioids such as fentanyl and its derivatives, and it has worsened during the COVID-19 pandemic. Concomitant with the rise of overdoses caused by synthetic opioids, deaths have risen despite increased availability of the current naloxone product. Administratively, too little too late can be life-threatening. The CDC has noted the need for multiple doses of the current nasal naloxone product, which suggests that a higher dose product may be necessary for the successful resuscitation of overdose victims. Additionally, there is concern that administering the nasal product could potentially put caregivers at risk of contracting COVID-19.

“Our 5 mg dose of naloxone delivered by intramuscular or subcutaneous injection has demonstrated significantly higher availability (naloxone in the blood) at 2.5 and 5 minutes (critical period) when compared to the current FDA-approved product. This should translate into more successful reversal of toxicity caused by higher potency synthetic opioids and potentially save many lives. We look forward to meeting with the FDA to discuss the responses that we have submitted to the agency to the issues raised in the most recent complete response letter relating to our New Drug Application for ZIMHI, and will continue to work with the FDA towards our goal to get ZIMHI approved.”