First over-the-counter opioid overdose treatment approved by FDA
pharmafile | March 31, 2023 | News story | Medical Communications |
The FDA has announced that it has approve Narcan, 4mg naloxone hydrochloride nasal spray for over-the-counter (OTC), non-prescription use. This is the first naloxone product to be approved for use without a prescription, and is the standard treatment for opioid overdose.
This approval marks a big change in the treatment of overdoses, as the life saving medication can now be sold directly to consumers in pharmacies, supermarkets, petrol stations and online.
Pricing and availability of the product is yet to be determined by the manufacturer, but according to the FDA’s press release it is aiming to maintain the availability of the drug in the meantime.
FDA commissioner Robert M Califf, MD, commented: “The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development and approval of an over-the-counter naloxone product to address the dire public health need. Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible at an affordable price.”
Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, added: “Naloxone is a critical tool in addressing opioid overdoses and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis. The FDA is working with our federal partners to help ensure continued access to all forms of naloxone during the transition of this product from prescription status to non-prescription/OTC status. Further, we will work with any sponsor seeking to market a non-prescription naloxone product, including through an Rx to OTC switch, and encourage manufacturers to contact the agency as early as possible to initiate discussions.”
Betsy Goodfellow
