In 2020, lethal overdoses involving opioids killed nearly 69,000 individuals, and 75% of all drug overdoses involved an opioid. Naloxone is an opioid receptor antagonist that can rapidly reverse the effects of opioids and thereby prevent the unfavorable consequences of opioid overdose. Naloxone is currently only available as a prescription medication but that may be changing. The U.S. Food and Drug Administration (FDA) has announced a Federal Register notice to help facilitate allowing naloxone hydrochloride to be available without a prescription. The preliminary assessment is being performed on intranasal formulations of naloxone up to 4 mg and up to 2 mg of naloxone in its intramuscular or subcutaneous forms. Higher doses and alternative delivery systems (e.g., syringes) are not covered by the Federal Register but may be looked into further in the future. This effort by the FDA to make naloxone products more widely accessible is part of the FDA Overdose Prevention Framework, which has 4 main priorities:

• Supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing.
• Encouraging harm reduction through innovation and education.
• Advancing development of evidence-based treatments for substance use disorders.
• Protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks.

References:

Centers for Disease Control and Prevention. The Drug Overdose Epidemic: Behind the Numbers. https://www.cdc.gov/opioids/data/index.html Accessed November 28, 2022.

Substance Abuse and Mental Health Services Administration. Naloxone. https://www.samhsa.gov/medication-assisted-treatment/medications-counseling-related-conditions/naloxone Accessed November 28, 2022.