- The Food and Drug Administration on Wednesday approved over-the-counter use of the opioid overdose treatment Narcan, making it the first naloxone-based product that can be given without a prescription.
- Narcan is a nasal spray from Emergent BioSolutions that can reverse opioid overdoses including from heroin, morphine and fentanyl, which has been a major contributor to the U.S. opioid crisis. Approving over-the-counter naloxone could help reduce drug overdoses by expanding accessibility of treatment.
- Emergent expects the nasal spray to be available by late summer. However, its over-the-counter price has not yet been disclosed, and different policies by various drug stores and pharmacies could vary where it’s available.
Despite efforts to curb overdoses, the opioid crisis continue to damage communities throughout the country. Overall, opioid deaths in the U.S. were increasing through 2021.
Approved since 2015, Narcan has become an important part of the public health response to reduce overdoses, and is now widely used by medical workers and first responders.
Emergent has worked to expand access to Narcan, submitting additional data to the FDA supporting the drug’s safety and efficacy when used over-the-counter. Emergent also had to show that people could use the drug without healthcare supervision, which the FDA said would require the company to change the labeling to provide clear directions.
The hope is that this approval will bolster harm reduction efforts across states. But accessibility has remained an issue, with some organizations struggling to provide naloxone due to local policies and lack of funding.
One remaining question is how much the drug will cost over the counter, and whether insurance providers will still cover its use. In an unusual statement addressing the cost of a treatment, FDA commissioner Robert Califf encouraged Emergent “to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”
Emergent’s timeline for making over-the-counter Narcan available is the result of time it needs to ready manufacturing of the nonprescription packaging. The drug will continue to be available via prescription in the meantime.
Other forms of naloxone won’t be available over the counter as a result of the FDA’s decision on Narcan, but could be if their manufacturers submit the required information to the agency. Generic makers that use Narcan as their reference product will also have to submit a supplemental application to convert their products.