Governor Tom Wolf Announces 60,000 Additional Naloxone Kits Available for First Responders Statewide
To help reduce drug overdose deaths, the first naloxone product to be licensed for use without a prescription is Narcan, a 4 milligram (mg) naloxone hydrochloride nasal spray, which is available over the counter (OTC) and without a prescription.
The conventional treatment for opioid overdose is naloxone, a drug that quickly reverses the effects of an overdose. The decision made today opens the door for the life-saving treatment to reverse an opioid overdose to be sold online and directly to consumers in locations including gas stations, convenience stores, grocery stores, and drug stores.
With the approval, consumers would have easier access to the nasal spray used to treat fentanyl and opioid overdoses since they may purchase it at pharmacies without a prescription or a pharmacist’s approval.
The manufacturer decides when this OTC product will be available and how much it will cost. To promote the continuing availability of naloxone nasal spray products during the month-long transition period from Narcan’s prescription to OTC status, the FDA will collaborate with all stakeholders. Additional naloxone dosages and formulations will continue to be available only by prescription.
The labeling for the presently approved 4 mg generic naloxone nasal spray products that use Narcan as its reference listed drug product will need to be changed in order for OTC Narcan nasal spray to be sold. To convert their items to OTC status, the manufacturers of these goods will need to submit a supplement to their applications. The FDA may make decisions on a case-by-case basis and contact more businesses as necessary, but the approval may also have an impact on the status of other brand-name naloxone nasal spray products containing 4 mg or less.
Having Narcan easily accessible is not just for drug addicts who overdose. Physicians Partnership of America reported, “As pharmacists, we try our best to stress the importance of having naloxone in the home while on opiate therapy,” said Samantha Dangler, vice president of Operations — Ancillary Division for Physician Partners of America. “With the opioid crisis at an all-time high, it is imperative that when a physician writes a prescription for an opiate and an antidote, that the patient follows through and fills the prescription for the antidote.”
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