Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) gained 6.93% following the announcement that the FDA had accepted to review its resubmitted New Drug Application for ZIMHI™. ZIMHI is a higher naloxone injection product candidate under development by the company for opioid overdose treatment. It lost 5.56% in the last trading session.
The FDA to review Adamis’ NDA for ZIMHI
The company received FDA communication about its NDA, indicating that the Agency had concluded its filing assessment and found that the NDA was sufficiently complete to allow a substantive review. The FDA also set a November 12, 2021 target action date under the Prescription Drug User Fee Act.
Dennis J. Carlo, Adamis CEO and President stated that they are delighted that the FDA has accepted the NDA for ZIMHI for review. He said that the acceptance emphasizes the necessity for additional opioid overdose treatment options. Carlo added that they are looking forward to engaging with the FDA during the review process to bolster the case for ZIMHI clearance.
Addressing the opioid crisis
Naloxone, which is an opioid antagonist, is used in treating drug overdoses. It is widely considered the first-line treatment in cases of opioid overdose. The drug works by blocking or reversing opioid effects such as excessive sleepiness, decreased breathing, and loss of consciousness. Some of the common opioids are morphine, oxycodone, tramadol, hydrocodone, heroin, and fentanyl.
Since 1999, the number of deaths caused by opioids has climbed by more than five times, according to the CDC. In the year ending May 2020, drug overdoses claimed the lives of almost 81,000 people in the US, an average of 220 people per day. Currently, drug overdoses are the top cause of mortality for Americans under the age of 50.
The availability of more potent synthetic opioids could lead to a rise in opioid overdose deaths.