The nasal spray, available at pharmacies without a prescription, is designed to counteract opioid overdoses.
RT’s Three Key Takeaways:
- Amneal Pharmaceuticals Inc has received FDA approval for its over-the-counter naloxone hydrochloride nasal spray, a generic equivalent to Narcan.
- The nasal spray is intended to help treat drug overdoses from opioids, including heroin, fentanyl, and prescription opioid medications, by providing emergency intervention.
- Amneal plans to increase its production capacity to up to 4 million two-packs by the end of 2024 and up to 10 million by the end of 2025.
Amneal Pharmaceuticals Inc announced it received US Food and Drug Administration approval for its over-the-counter naloxone hydrochloride nasal spray.
Amneal’s naloxone nasal spray, 4 mg, a generic equivalent to over-the-counter Narcan hydrochloride nasal spray, is intended 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,” says Chirag and Chintu Patel, co-chief executive officers, in a release.
Further reading: FDA Approves Second OTC Naloxone Nasal Spray
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.
The product will be available at pharmacies. Amneal expects to have production capacity of up to 4 million two-packs by the end of 2024 and up to 10 million by the end of 2025. The product is made in the United States at one of Amneal’s manufacturing facilities in New Jersey.
Further reading: FDA Approves Narcan Nasal Spray for OTC Use
Photo caption: Amneal’s over-the-counter naloxone hydrochloride nasal spray, 4 mg
Photo credit: Amneal Pharmaceuticals Inc
