FDA approves over the counter naloxone hydrochloride spray for opioid overdose

The US Food and Drug Administration (FDA) has approved over-the-counter naloxone hydrochloride nasal spray for emergency treatment of opioid overdose.

Amneal’s Naloxone HCI Nasal Spray, manufactured in the U.S., is a generic equivalent to OTC NARCAN® HCI Nasal Spray, a medication that is widely used to help treat drug overdose from opioids, including heroin, fentanyl and prescription opioid medications.

“With today’s launch, Amneal is proud to help address this public health emergency by providing naloxone nasal spray at an affordable price and without a prescription. Our business is deeply rooted in a commitment to helping others. 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, Co-Chief Executive Officers.

More than two-thirds of all drug overdose fatalities in 2022 involved illicit, synthetic opioids like fentanyl, which is the culprit in more deaths under age 50 than any other cause, including heart disease, cancer, homicide, suicide, and other accidents. According to the Centers for Disease Control and Prevention, in about 46% of overdose deaths, another person is present and has the potential to intervene.

Amneal Naloxone HCI Nasal Spray is now available. According to IQVIA®, U.S. annual commercial sales for NARCAN® Naloxone HCl Nasal Spray 4mg for the 12 months ended February 2024 were $266 million. In addition, there are significant volumes of the product acquired directly by U.S. states and municipalities. NARCAN® is a registered trademark of Emergent Operations Ireland Limited.

About Naloxone Nasal Spray

Naloxone Hydrochloride (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 effects of opioids. It can restore normal breathing within two to three minutes in a person whose breath has slowed, or even stopped, as a result of an overdose from opioids-including heroin, fentanyl and prescription opioid medications. Naloxone HCI Nasal Spray contains the same active ingredient and dose as NARCAN® Naloxone HCI Nasal Spray, 4 mg. It is easy to carry and can be safely used even if opioids are not present.

When using this product some people may experience symptoms when they wake up, such as shaking, sweating, nausea, or feeling angry. This is to be expected.

About the Opioid Crisis

The opioid epidemic was declared a national public health emergency in 2017 and has continually been renewed by the U.S. Secretary of Health and Human Services.4,5 Ending the epidemic is a top strategic priority of the U.S. government and Congress.6 Since 2000, about one million people in the U.S. have died of drug overdoses, the majority of which were due to opioids. Drivers of this crisis include the misuse of prescription pain medication and the unwitting use of drugs laced with fentanyl-which is 50 times more potent than heroin and 100 times more potent than morphine. In 2022, roughly twice as many people died in the U.S. from opioid-related overdoses than from motor vehicle crashes.