March 29, 2023 – The FDA has approved the drug to treat opioid overdose Narcan for over-the-counter use, the agency announced Wednesday morning.
The nasal spray incorporates the drug naloxone hydrochloride and will probably be available online in addition to in drugstores, grocery stores and gas stations. Since 2016, it has also been available by prescription.
More than 100,000 people die from opioid overdoses annually within the United States, with most of those deaths involving synthetic opioids reminiscent of fentanyl. FDA Commissioner Robert M. Califf said making Narcan more available would meet an “urgent public health need.”
However, it's unclear how much the nasal spray will cost and whether the product will probably be available over-the-counter in pharmacies. Currently, major pharmacy chains reminiscent of CVS and Walgreens offer naloxone over-the-counter, but consumers must ask a pharmacist to dispense the medication.
“The big question is what it will cost,” said Brian Hurley, MD, President-elect of the American Society of Addiction Medicine. “For people to have access to it, they have to be able to afford it.”
“We won’t accomplish much if people can’t afford Narcan,” said National Council for Mental Wellness President and CEO Chuck Ingoglia in an announcement. However, he noted that “no single approach will end overdose deaths, but making Narcan readily available and widely available will likely save countless lives each year.”
“[The] “The FDA’s decision will transform our compassionate and logical response to the overdose epidemic,” said Bobby Mukkamala, MD, chair of the American Medical Association’s Substance Use and Pain Care Task Force. in a statement“More lives will be saved when naloxone is readily available in grocery stores and pharmacies,” and it “will help destigmatize the acquisition and use of naloxone,” he said.
But for this change to have the greatest impact, manufacturers must ensure that naloxone is affordable, a critical element for community organizations working to make the drug available,” he said.
In a statementThe FDA said the price of the drug and the timeline for its availability “will be determined by the manufacturer.”
“We encourage the manufacturer to prioritize accessibility of the product by making it available as quickly as possible and at an affordable price,” Califf said.
Emergent BioSolutions didn't comment on the prices. It said in a statement The spray will probably be “available on shelves and through online retailers in the U.S. starting in late summer” after Narcan is customized for direct-to-consumer use, including more consumer-focused packaging.
The cost of naloxone varies depending on geographic location and whether it's generic. According to GoodRX, a pack of two doses of generic naloxone costs $31 to $100, depending on location and coupon availability. A pack of two doses of Narcan costs $135 to $140. Emergent reported a decrease of 14% naloxone sales in 2022 – to $373.7 million – due partly to the introduction of generic formulations.
Hurley believes the individuals who buy Narcan at a drugstore are primarily those shopping there. They could also be those almost certainly to overdose, reminiscent of people being released from prison or those that are homeless, he said.
The over-the-counter availability of Narcan “is an important complement, but it does not replace existing naloxone distribution programs,” Hurley said.
The FDA has encouraged manufacturers of naloxone to use for OTC approval since a minimum of 2019, when it designed a model label for a theoretical OTC product. In November, the agency said it had certainly that some naloxone products could also be protected and effective when used over-the-counter and reiterated its call for drug manufacturers to hunt such approval.
Emergent BioSolutions was the primary manufacturer to hunt OTC approval, but one other manufacturer, the nonprofit Harm reduction therapeutics, is waiting for approval of its application to sell its spray on to consumers. In December, Harm Reduction Therapeutics announced that its application for a nasal spray was being fast-tracked by the FDA and that, if approved, the product could possibly be sold at cost price of $18.
Mukkamala said the AMA is urging all manufacturers to hunt OTC approval and urged manufacturers to work with retailers to spotlight the products on store shelves. Health insurers “must continue to cover the cost of naloxone at no or low cost, or do so as well,” the AMA said.
Scott Gottlieb, MD, who was FDA Commissioner from 2017 to 2019, said in a tweet that more work is required.
“This regulatory move should be followed by a strong push by elected officials to support broader use of Narcan and get more doses into the hands of vulnerable households and frontline workers,” he tweeted.
When Narcan is more available, it's more more likely to be readily available in an emergency. The drug can restore respiration that has slowed or stopped during an opioid overdose. published instructions When using Narcan, we recommend that you simply only use the medication after an opioid overdose has been diagnosed. To do that, you have to follow these steps:
- Ask the person if every little thing is OK and call their name. Shake the person's shoulders and rub their chest firmly.
- Watch for signs of an opioid overdose, reminiscent of if the person doesn't get up or responds to your touch or voice; respiration could be very slow or irregular or has stopped; and their pupils appear to be pinpoints.