Originally published by our sister publication Pain Medicine News
The FDA has approved over-the-counter (OTC) naloxone hydrochloride (HCI) nasal spray, USP, 4 mg (Amneal Pharmaceuticals), following an abbreviated new drug application review. Naloxone HCI Nasal Spray is a generic equivalent to OTC Narcan HCI Nasal Spray (Emergent), a medication that is widely used to help treat drug overdose from opioids, including heroin, fentanyl and prescription opioid medications.
Naloxone HCI Nasal Spray is designed to rapidly reverse the effects of a life-threatening opioid emergency by binding to opioid receptors and reversing or blocking the action of opioids. It can restore normal breathing within two to three minutes in a person whose respiration has slowed or even stopped, as a result of an opioid overdose.
“We recognize the tragic impact the opioid crisis has on families across the U.S. By enhancing access to naloxone nasal spray, we hope to get this affordable emergency treatment into the hands of even more people who could potentially save countless families and communities from further heartache and loss,” said Chirag and Chintu Patel, the co-CEOs of Amneal, in a statement.
More than two-thirds of all drug overdose fatalities in 2022 involved illicit, synthetic opioids like fentanyl (Morb Mortal Wkly Rep 2023;72[26]:721-727). According to the CDC, in about 46% of overdose deaths, another person is present and has the potential to intervene.
Based on a press release from Amneal.