At Last, FDA Signs Off on Adamis’ Opioid Overdose Drug


Shares in Adamis Pharmaceuticals rose 31% Monday on news that the U.S. Food and Drug Administration has approved its naloxone injection Zimhi for the treatment of opioid overdose. This was Adamis' third attempt to have the drug approved, following two CRLs. 

Zimhi, a prescription naloxone HCL injection at 5 mg/0.5 ml, is a high-dose drug that works to block or reverse the effects of opioids, which include slowed breathing, extreme drowsiness, or loss of consciousness. Zimhi is indicated for use in both adults and children in the event of an emergency. It is to be given right away and does not take the place of emergency care. Persons suspected of overdose still need emergency services immediately, even if the patient wakes up. Signs and symptoms might continue for a few minutes after the drug is administered. If such occurs, additional injections may be given using a new prefilled syringe every 2 to 3 minutes, with close supervision, until medics arrive.

"I am pleased to see this much-needed high dose naloxone product will become part of the treatment tool kit as a countermeasure to the continued surge in fentanyl-related deaths. The higher intramuscular doses of naloxone in ZIMHI should result in more rapid and higher levels of naloxone in the systemic circulation, which in turn, should result in more successful resuscitations," said Dr. Jeffrey Galinkin, a former member of the FDA Advisory Committee for Anesthetics, Analgesics and Addiction Products, in a statement. 

Latest figures from the Centers for Disease Control and Prevention (CDC) show that drug overdose accounted for 96,779 deaths in the U.S. alone in the one-year period between March 2020 and March 2021 — a 29% increase from the previous year. Drug overdose is now the leading cause of death in the country under the age of 50. 

Adamis is distributing Zimhi with US WorldMeds as its partner.

"We are very excited by this approval and are working with our commercial partner, US WorldMeds, to make this much-needed, lifesaving product readily available to the market. ZIMHI provides the highest systemic levels of naloxone compared to any of the nasal or intramuscular products currently available," added Dr. Dennis J. Carlo, president and chief executive officer of Adamis, in the same press release. 

Zimhi is indicated only for persons who have overdosed on opioids and will, thus, have no effect on people who are not taking these. It is also contraindicated for those allergic to naloxone hydrochloride or any of the drug's ingredients.

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