FDA Approves Over-the-Counter Naloxone Nasal Spray for Opioid Overdose

Amneal Pharmaceuticals announced on April 24, 2024, that the US Food and Drug Administration (FDA) approved the over-the-counter naloxone hydrochloride nasal spray for emergency treatment of an opioid overdose.¹

The approval followed an Abbreviated New Drug Application (ANDA) for naloxone hydrochloride (Naloxone HCI) nasal spray at 4mg. This is the generic equivalent to the Narcan HCI Nasal Spray, a medication used to treat drug overdose from opioids, such as heroin, fentanyl, and prescription opioid medications. Narcan HCI Nasal Spray 4 mg was approved in March 2023 for nonprescription, over-the-counter use.²

The generic equivalent has the same active ingredient and dose as Narcan Naloxone HCI Nasal Spray.¹ Naloxone HCI nasal spray 4 mg rapidly reverses the effects of an opioid emergency by binding to opioid receptors and reversing or blocking the effects of opioids. The spray helps restore breathing to normal within 2 to 3 minutes, regardless of if the breathing just slowed or stopped due to the overdose.

More than two-thirds of all drug overdose deaths in 2022 included illicit synthetic opioids like fentanyl. For people under 50, overdose leads to more deaths than heart disease, cancer, homicide, suicide, and other accidents. The Centers for Disease Control and Prevention (CDC) reported about 46% of overdose deaths have another person present—a person who can intervene.

Although Narcan Naloxone HCl Nasal Spray 4mg was on the market, it cost a lot. The annual commercial sales ending in February 2024 were $266 million.

Amneal Naloxone HCI Nasal Spray is now available on the market. People may experience symptoms when they wake up, including shaking, sweating, nausea, or anger.

“Amneal is proud to help address this public health emergency by providing naloxone nasal spray at an affordable price and without a prescription,” said Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal, in a press release. “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.”

References

1. ^{Amneal Announces U.S. FDA Approval of Over-the-Counter Naloxone Hydrochloride Nasal Spray for Emergency Treatment of an Opioid Overdose. Business Wire. April 24, 2024. https://www.morningstar.com/news/business-wire/20240424236083/amneal-announces-us-fda-approval-of-over-the-counter-naloxone-hydrochloride-nasal-spray-for-emergency-treatment-of-an-opioid-overdose. Accessed April 25, 2024.}
2. ^{Campbell, P. FDA Approves Narcan Nasal Spray for Over-the-Counter Use. HCPLive. March 29, 2023. https://www.hcplive.com/view/fda-approves-narcan-nasal-spray-for-over-the-counter-use. Accessed April 25, 2024.}