FDA Approves Narcan for Over-the-Counter Use

The U.S. Food and Drug Administration has approved over-the-counter Narcan, a naloxone nasal spray that can ameliorate opioid overdoses and save lives.

In an announcement Wednesday, FDA Commissioner Robert M. Calif said the move was intended to address “an urgent public health need” to reduce opioid overdose deaths in the country. , said it helps increase access.

Administered via a nasal sprayer, Narcan is a fast-acting opioid antagonist that reverses the effects of opioids such as heroin, fentanyl, codeine, and OxyContin. This drug binds to receptors in the nervous system and blocks or reverses the effects of opioids in an individual’s system. Dispensed when someone is showing signs of overdose, such as nodding, choking, or showing constricted pupils, it’s surprisingly effective. One study found that 93.5% of those who received naloxone survived their overdose. Naloxone does not harm people who do not have opioids in their body, but it does not work with non-opioid drugs.

“Naloxone, or Narcan in nasal spray form, is essentially the only treatment option for opioid overdose outside of medical settings,” said a medical toxicologist, addiction medicine expert, and Case Western Reserve University. said emergency physician Ryan Marino. Medicine told BuzzFeed News. The drug naloxone is also available in an injectable form for use by health care providers. However, the FDA rule change allowing over-the-counter marketing applies only to his Narcan and not to other formulations or dosages of naloxone.

This drug does not treat addiction, nor does it prevent someone from using drugs or help them enter a recovery program. “The only one is Narkan,” said Marino.

Narcan is now available at pharmacies in most states without a prescription, but it is usually sold over-the-counter and some states have additional restrictions that make it more difficult to obtain.

Due to the rule change, Narkan will now be placed directly on the shelf. However, even under current regulations, naloxone remains relatively accessible. Its cost varies by store and location and can be very expensive, but harm reduction organizations and even some city programs make the drug available for free.

While the change is “gradual,” Marino says it will also help reduce stigma and misconceptions associated with naloxone.

“People don’t want Narkan in school. People worry that this will encourage drug use. These are not true,” he said. “I think what people need to know is that this is a life-saving antidote. It’s like putting out an epipen, a defibrillator in the community. It’s what you want to use. Not, but the alternatives are much worse.”