- The stock price of Adamis Pharmaceuticals Corp (NASDAQ: ADMP) increased by over 13% this morning. This is why it happened.
The stock price of Adamis Pharmaceuticals Corp (NASDAQ: ADMP) increased by over 13% this morning. Investors are responding positively to Adamis Pharmaceuticals announcing that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s resubmitted New Drug Application (NDA) for ZIMHI — which is its higher naloxone injection product candidate for the treatment of opioid overdose.
Adamis had 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 provided a target action date under the Prescription Drug User Fee Act (PDUFA date) of November 12, 2021.
Naloxone is known as an opioid antagonist used to treat narcotic overdoses and is generally considered the treatment of choice for immediate administration in instances of opioid overdose. And Naloxone blocks or reverses effects of the opioid, including drowsiness, slowed breathing, and loss of consciousness. Some of the common opioids include morphine, heroin, tramadol, oxycodone, hydrocodone and fentanyl. The number of deaths due to opioids increased over 5 times since 1999, according to statistics published by the Centers for Disease Control and Prevention.
Over the past year ending May 2020, drug overdoses resulted in about 81,000 deaths in the United States – greater than approximately 220 deaths per day. And drug overdoses are now the leading cause of death for Americans under 50.
“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. We look forward to working collaboratively with the FDA during the review process to support the case for approval of ZIMHI.”
— Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals
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