Treating overdose with Naloxone

In 2017, the opioid crisis—which includes the overuse, abuse, and overdose deaths caused by both illegal and legal opioids—was considered a public health emergency. Opioids are used for the treatment of pain and include medicines such as morphine, fentanyl and tramadol. Due to their pharmacological effects, they can cause breathing difficulties. Overdose can be fatal leading to death.

The Opioid PHE proclamation has been extended numerous times since 2017. By January 2022, over 80,000 people died from opioid-related overdoses, out of which 75% of those were related to a drug overdose. To resolve the public health problem and decrease opioid overdose deaths, naloxone is an essential tool. Respiratory and central nervous system (CNS) depression, which are life-threatening symptoms of opioid overdose, can cause considerable morbidity and fatality.

By removing opioids from the mu-opioid receptor in the central nervous system (CNS), naloxone, a non-selective opioid receptor antagonist, reverses the effects of respiratory depression and sedation. Naloxone can be administered promptly within minutes of the onset of an opioid overdose, to reverse its effects.

Announcement:

The Food and Medication Administration is announcing our preliminary conclusion that some naloxone hydrochloride ("naloxone") drug products may be approved as safe and effective for use without a prescription. Naloxone autoinjectors for intramuscular (IM) or subcutaneous (SC) usage up to 2 mg, as well as a nasal spray up to 4 mg, have the potential to be safe and effective when used as instructed on nonprescription drug labelling without the guidance of a healthcare professional. For the sake of the general welfare, the prescription requirement for certain naloxone medications may not be necessary. However, product-specific data may be required for non-prescription user interface design (package and labelling).

The Federal Food, Medicine, and Cosmetic Act prohibits the simultaneous marketing of a drug with the same active component as both a prescription and nonprescription product. When the FDA has data to support the approval of a nonprescriptive naloxone product, those marketed currently and labelled as "Rx only" will be considered misleading.