Narcan, a 4 milligram (mg) naloxone hydrochloride nasal spray, is the first naloxone product to be approved for use without a prescription and is available over the counter (OTC) to help reduce drug overdose fatalities.
Naloxone, a drug that rapidly reverses the effects of an overdose, is the standard therapy for opioid overdose. In light of today’s decision, the potentially lifesaving treatment to reverse an opioid overdose can now be sold online and directly to consumers at places such as gas stations, convenience stores, grocery stores, and drugstores.
The clearance means that the nasal spray used to treat fentanyl and opioid overdoses will be available at shops without the need for a prescription or the knowledge of a pharmacist.
The price and availability of this over-the-counter product are set by the maker. During the month-long transition phase from prescription to OTC status for Narcan, the FDA will work with all stakeholders to promote the continued availability of naloxone nasal spray products. Prescriptions are still the only way to get access to the full range of naloxone strengths and delivery systems.
In order for OTC Narcan nasal spray to be sold, the labeling for currently authorized 4 mg generic naloxone nasal spray products that use Narcan as its reference listed drug product must be modified. Manufacturers of these products will need to file an addendum to their applications in order to have them classified as OTC. The approval may affect the standing of other brand-name naloxone nasal spray products with 4 mg or less, though the FDA may make decisions on a case-by-case basis and contact additional businesses as required.
Victims of overdose aren’t the only ones who benefit from having Narcan on hand. According to a report by Physicians Partnership of America, Samantha Dangler, VP of Operations for the Ancillary Division, said, “As pharmacists, we try our best to stress the importance of having naloxone in the home while on opiate therapy.” In light of the current opioid epidemic, it is crucial that patients who are prescribed both opiates and their respective antidotes actually take the latter.
CWEBÂ has provided some information for this story.
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