FDA approves over-the-counter sale of opioid overdose antidote Narcan

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 drug used to reverse the effects of opioids, usually in overdose.

"Today's action supports our efforts to address the opioid overdose crisis by helping to expand access to naloxone," said the Commissioner of the FDA, Robert M. Califf, when the FDA issued the notice.

According to experts, this is a measure that would eliminate barriers to access to life-saving drugs if they are administered on time.

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

"Today, the United States Food and Drug Administration issued a Federal Register advisory, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, which may help facilitate the development and approval of certain naloxone over-the-counter pharmaceutical products, including through the conversion of certain naloxone drug products from prescription to over-the-counter status,” according to the FDA.

Two forms of medication, a nasal spray and an auto-injector, could potentially be safe and effective for over-the-counter use. “We are currently of the preliminary opinion that naloxone nasal spray up to 4 milligrams (mg) and naloxone auto-injector for intramuscular (IM) or subcutaneous (SC) use up to 2 mg, have the potential to be safe and effective for use as directed in OTC drug labeling without the supervision of a healthcare professional,” the FDA noted.

Naloxone is only available by prescription, although many states have found workarounds to make it easier to get the drug. Through so-called standing orders, for example, people can request naloxone from a pharmacist, NBC News reported. Now people could buy it online or in-store through self-checkout.

Dr. Scott Hadland, an addiction specialist at Mass General for Children in Boston, said making the drugs available over-the-counter removes the stigma. “There has been great pressure from advocacy groups over the past few years to make the drug more readily available,” said Dr. Michael Barnett, assistant professor of health policy and management at Harvard T.H. Chan School of Public Health.

"Over-the-counter naloxone is still expected to go through the FDA for review and approval," Barnett said, but could start rolling into pharmacies as early as next year.

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

Nearly 20,000 overdose deaths between 1999 and 2020 were prevented by self-administered naloxone, according to the FDA.

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

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