A few days ago, the stock price of Adamis Pharmaceuticals rose by 31%. The reason may be that the US Food and Drug Administration (FDA) approved the company's injection of naloxone Zimhi for the treatment of opioid overdose.

Zimhi is a 5 mg/0.5 ml high-dose prescription naloxone hydrochloride injection that can block or reverse the effects of opioids, including slowed breathing, extreme drowsiness, or loss of consciousness. Zimhi is suitable for adults and children to use in emergency situations, but cannot replace emergency care.

It should be pointed out that this is the third attempt by Adamis after two complete response letters (CRL), and the drug has been approved. In November 2019, Adamis's New Drug Application (NDA) for its Zimhi high-dose naloxone injection product was rejected by the FDA. At that time, the CRL pointed out that the FDA believed that it could not approve the listing of Zimhi and provided suggestions for resubmission of the application. Affected by this bad news, Adamis's share price plummeted by 50.96% to $0.62 per share.

Compared with other drugs that require nasal or intramuscular injection, among currently available products, Zimhi can provide patients with the highest level of naloxone throughout the body. After the administration, the patient’s signs and symptoms may last for a few minutes. If this happens, a new pre-filled syringe can be used for additional injections every 2 to 3 minutes and closely monitored until the medical staff arrives.

It should be noted that Zimhi is only suitable for people who overdose opioids, so it has no effect on people who do not take these drugs. People who are allergic to naloxone hydrochloride or any drug ingredients are also banned from the drug. Jeffrey Galinkin, a former member of the FDA's Narcotics, Analgesics, and Addictive Products Advisory Committee, said that he is pleased to see that this much-needed high-dose naloxone product will become part of the treatment tool as a response to the continued fentanyl-related deaths. Countermeasures to surge.