FDA Approves Opioid Overdose Antidote Narcan For OTC Sale

The Food and Drug Administration has determined that certain naloxone products like Narcan are safe enough to potentially be sold without a prescription. Narcan, a brand name for naloxone, is a medication used to reverse the effects of opioids, usually in the case of an overdose. 

“Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone,” said FDA Commissioner Robert M. Califf when the FDA issued the notice.

According to the experts, it's a move that would remove barriers to accessing the life-saving medication if given in time.

What Did The FDA Say?

The agency said that it strongly encourages naloxone makers to contact the FDA as early as possible to initiate a discussion about a potential switch from prescription to over-the-counter.

“Today, the U.S. Food and Drug Administration issued a Federal Register notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, that may help facilitate the development and approval of certain nonprescription naloxone drug products, including through the switch of certain naloxone drug products from prescription status to nonprescription status,” per the FDA.

Two forms of the drug, a nasal spray and an autoinjector, could potentially be safe and effective for over-the-counter use. “It is our preliminary opinion at this time that naloxone nasal spray up to 4 milligrams (mg), and naloxone autoinjector for intramuscular (IM) or subcutaneous (SC) use up to 2 mg, have the potential to be safe and effective for use as directed in nonprescription drug labeling without the supervision of a healthcare practitioner,” noted the FDA.

Naloxone is only offered as a prescription, though many states have found workarounds to make the drug easier to get. Through so-called standing orders, for example, people can request naloxone from a pharmacist, reported NBC News. Now, people would be able to purchase it online or in-store via self-checkout.

Dr. Scott Hadland, an addiction specialist at Mass General for Children in Boston, said making the medication available over the counter removes the stigma.  "There’s been a big push from advocacy groups over the past few years to make the drug more easily available,' said Dr. Michael Barnett, an assistant professor of health policy and management at the Harvard T.H. Chan School of Public Health.

“Over-the-counter naloxone would still need to be submitted to the FDA for review and approval,” Barnett said but could start rolling in drugstores as early as next year.

Opioid Overdoses

According to the Centers for Disease Control and Prevention (CDC), more than 107,600 Americans died from drug overdoses lasts year. The majority involved fentanyl, a powerful synthetic opioid.

Nearly 20,000 deaths from overdose, between 1999 and 2020, have been prevented by self-administering of naloxone, according to the FDA.

In September, the White House announced $1.5 billion in funding to tackle opioid overdoses and remove barriers to key tools like naloxone.

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Photo: Courtesy Of Pharmacy Images On Unsplash

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Posted In: NewsHealth CareFDAMarketsGeneralCDCNarcanopioid addictionRobert M. Califf
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