Narcan will soon be available without a need for a prescription.
The Food and Drug Administration announced Wednesday that it has approved the very first over-the-counter Narcan nasal spray. The FDA made this move in an effort to reduce overdose deaths caused by opioids.
This approval was granted to Emergent BioSolutions and will be for the 4-milligram (mg) naloxone hydrochloride nasal spray.
Narcan, of which the drug naloxone is the main component, is a life-saving medication used to quickly reverse the effects of opioid overdose.
A panel of FDA officials had previously recommended reclassifying this spray as an over-the-counter medication as producers made the instructions for administration easy to understand without the help of a medical professional, as previously reported by The Dallas Express.
Officials said this medication will be available for purchase in drug stores, convenience stores, grocery stores, gas stations, and online.
The agency reported that more than 100,000 individuals in the United States have died due to overdose from drugs such as fentanyl in the year ending in October 2022.
FDA Commissioner Robert Califf said in the release that producers of this medication are advised to prioritize making it available and affordable “as soon as possible” amid the ongoing opioid crisis.
“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 of and approving an over-the-counter naloxone product to address the dire public health need,” said Califf in the release.
The FDA, however, warned that full implementation of this approval could take months and that other dosages and formulations of the drug would remain as prescription medication. Producers must also change the labels on affected products and submit a supplement to their applications when reclassifying the medication.
The FDA said that the timing and price of Narcan will be determined by its producers, but that the agency would continue to supplement the product’s availability during its transition to over-the-counter status.
“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,” said Patrizia Cavazzoni, the FDA’s director for the Center for Drug Evaluation and Research, according to the press release.
“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 nonprescription/OTC status,” she continued.
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