Adamis Pharmaceutical Corp. (NASDAQ: ADMP) stock fell by 7.37% at the last close while the ADMP stock price kept declining by 20.02% in the pre-market trading session. Adamis Pharmaceuticals Corporation is a specialist biopharmaceutical firm specializing in the development and commercialization of drugs for a variety of clinical fields, including asthma, opioid addiction, cardiovascular, and inflammatory disease.
On April 12, 2021, ADMP’s CEO informed the shareholders that at their Type A conference, they understand they received critical insight from the FDA on a variety of matters, as well as confirmation of the agency’s commitment to a swift review of the NDA. Currently, 88,000 people have died from opioid poisoning in the 12-month timeframe ended in August 2020, and deaths have jumped by 27% compared to the prior year during the COVID-19 pandemic. Also, he mentioned that ADMP assumes that making their higher-dose naloxone medication available to the public might theoretically save thousands of lives.
Following this, on May 17, 2021, ADMP revealed that ZIMHITM, a naloxone injection product has had it’s New Drug Application (NDA) resubmitted to the US Food and Drug Administration (FDA).ZIMHI is a heavy-dose naloxone injection medication for the treatment of opioid addiction. Naloxone is an opioid antagonist and is widely regarded as the drug of choice for treating opioid overdoses in the short term.
Dr. Dennis J. Carlo, President, and CEO of Adamis Pharmaceuticals stated:
ADMP has resubmitted their NDA for ZIMHI, which he is really confident that it caters the concerns posed in November 13, 2020, Complete Response Letter, relying on FDA feedback obtained during their Type A meeting in April. As the department continues its analysis of the resubmitted NDA, ADMP is committed to working collaboratively with them. He continues to believe that more naloxone drugs, especially their higher-dose intramuscular injection medication, which has clear advantages over the two licensed intranasal products, might save thousands of lives.