FDA Approves Generic OTC Naloxone Nasal Spray


Amneal Pharmaceuticals said its generic naloxone hydrochloride nasal spray is now available in the US following FDA approval.

The FDA has approved a generic 4 mg naloxone hydrochloride nasal spray for OTC use to treat drug overdose from opioids, Amneal Pharmaceuticals said in a release.1 With the new approval, there are now 3 naloxone hydrochloride nasal spray options for OTC use in the United States.

FDA Approves Generic OTC Naloxone Nasal Spray / pureradiancecmp - stock.adobe.com

FDA Approves Generic OTC Naloxone Nasal Spray / pureradiancecmp - stock.adobe.com

The naloxone hydrochloride from Amneal is a generic equivalent to OTC Narcan, which received approval from the FDA in March 2023. Naloxone hydrochloride is an opioid antagonist that can temporarily reverse a drug overdose from opioids, including heroin, fentanyl, and prescription opioids. By blocking the effects of opioids, it restores normal breathing within 1 to 2 minutes.2

Key Takeaways

  • The FDA's approval of a generic 4 mg naloxone hydrochloride nasal spray for OTC use adds to the available options for individuals seeking access to opioid overdose treatment without a prescription.
  • With opioid overdose deaths continuing to rise, reaching over 106,000 in 2021 according to data from NIDA, the availability of OTC naloxone becomes increasingly critical as a rapid and effective intervention to combat the epidemic.
  • Amneal Pharmaceuticals' launch of generic naloxone nasal spray underscores efforts to enhance access to this life-saving medication by offering it at an affordable price without the need for a prescription

“Naloxone hydrochloride nasal spray is a critical tool in addressing the opioid public health emergency across the United States,” Andy Boyer, chief commercial officer of Amneal Generics, said in a release.3 “We are well prepared to launch this product at a significant scale and substantially increase access to this life-saving medicine as we work to help combat this endemic crisis.”

According to data from the National Institute on Drug Abuse, there were over 106000 overdose deaths in 2021.4 More than 80000 of those deaths involved an opioid, up from the 68630 deaths in 2020. Overdose deaths in the country show no sign of slowing down. Recent data from the CDC showed there were 109000 overdose deaths in 2022 with 70% due to synthetic opioids like fentanyl, highlighting the critical need for quick and effective overdose treatment.5

READ MORE: On the Front Lines: Pharmacists' Role in Combating America's Opioid Epidemic

Naloxone hydrochloride was first approved by the FDA as a prescription drug in 2015. Emergent BioSolutions, the manufacturer of Narcan, provided the FDA with data showing the drug can be used safely and effectively as directed in the proposed labeling to facilitate the switch from prescription to OTC product. The company also showed consumers could understand how to use it effectively without the supervision of a health care professional.

“The FDA remains committed to addressing the evolving complexities of the overdose crisis,” Robert M. Califf, MD, commissioner of the FDA, said in a release at the time of Narcan’s OTC approval.6 “As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an OTC naloxone product to address the dire public health need."

Following the OTC approval of Narcan, Harm Reduction Therapeutics received OTC approval for its 3 mg naloxone hydrochloride nasal spray (RiVive) in July 2023. The company said it plans to make its product available across the US free of charge or at a low breakeven cost.

In its release, Amneal said that its generic naloxone hydrochloride nasal spray is now available in the US.

“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,” Chirag and Chintu Patel, co-chief CEOs of Amneal, said in a release.1 “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.”

READ MORE: Substance Use Disorder Resource Center

1. Amneal Announces U.S. FDA Approval of Over-the-Counter Naloxone Hydrochloride Nasal Spray for Emergency Treatment of an Opioid Overdose. News Release. Amneal Pharmaceuticals. April 24, 2024. Accessed April 25, 2024. https://investors.amneal.com/news/press-releases/press-release-details/2024/Amneal-Announces-U.S.-FDA-Approval-of-Over-the-Counter-Naloxone-Hydrochloride-Nasal-Spray-for-Emergency-Treatment-of-an-Opioid-Overdose/default.aspx
2. Lifesaving Naloxone. Report. CDC. April 21, 2023. Accessed April 25, 2024. https://www.cdc.gov/stopoverdose/naloxone/index.html
3. Amneal Announces U.S. FDA Filing Acceptance of Abbreviated New Drug Application for Naloxone Hydrochloride Nasal Spray, USP, 4mg. News Release. Amneal Pharmaceuticals. March 2, 2023. Accessed April 25, 2024. https://investors.amneal.com/news/press-releases/press-release-details/2023/Amneal-Announces-U.S.-FDA-Filing-Acceptance-of-Abbreviated-New-Drug-Application-for-Naloxone-Hydrochloride-Nasal-Spray-USP-4mg/default.aspx
4. Drug Overdose Death Rates. Report. NIH. June 30, 2023. Accessed April 25, 2024. https://nida.nih.gov/research-topics/trends-statistics/overdose-death-rates
5. Tanz LJ, Gladden RM, Dinwiddie AT, et al. Routes of drug use among drug overdose deaths—United States, 2020-2022. MMWR Surveill Summ. 2024;73(6):124-130. doi: 10.15585/mmwr.mm7306a2
6. FDA Approves First Over-the-Counter Naloxone Nasal Spray. News Release. FDA. March 29, 2023. Accessed April 25, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray
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