Science

FDA takes steps to authorize some overdose-reversing drugs for over-the-counter sale

The US Food and Drug Administration has issued a notice that should help expand access to overdose-reversing naloxone drug products without the need for a prescription, paving the way for making more of them available for over-the-counter use. Could

Naloxone is a drug that blocks opiate receptors in the nervous system and rapidly reverses opioid overdose when given to an overdosed person in a timely manner. More than 107,000 Americans will die of overdoses in 2021, according to provisional data from the Centers for Disease Control and Prevention. About 75% of those overdoses were related to opioids, including heroin and fentanyl.

“Today’s action supports our efforts to address the opioid overdose crisis by helping to increase access to naloxone,” FDA Commissioner Robert M. Calif, MD, said in a Tuesday press release announcing the notice. “The agency will keep overdose prevention and substance use disorders reduction as a key priority and an area of ‚Äč‚Äčintense strategic focus for action as soon as possible.”

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Naloxone may be packaged as a nasal spray or as an injectable drug.

Naloxone is available in all 50 states, and according to the CDC, “many states have laws that allow pharmacists to dispense naloxone without a prescription.” Community-based programs and syringe exchange services may also distribute naloxone.

The notice issued by the FDA, known as a Federal Register notice, is intended to change certain naloxone drug products from prescription status to nonprescription status, in addition to the development and approval of new products. The notice includes a preliminary assessment that states that some naloxone products, both nasal and injectable, may be acceptable as “safe and effective for non-prescription use.”

While the evaluation is a step forward, it is not a final determination that certain naloxone products are safe and effective for nonprescription use, and it does not mandate that naloxone products be immediately available for over-the-counter purchase. The final decision will be made by the FDA, based on additional data that would typically be submitted to the agency in an application for a proposed nonprescription naloxone product.


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It’s one of several steps taken by the FDA and other public health agencies in recent years to combat the nation’s overdose crisis. The FDA has established the FDA Overdose Prevention Framework, which aims to “take effective, constructive action to prevent drug overdoses and reduce deaths”.

In addition to the FDA’s push to make naloxone more accessible nationwide, the CDC has spoken out in support of test strips, a harm reduction tool that lets people access drugs that detect the presence of fentanyl in their substances. Let’s examine. According to provisional data from the CDC, fentanyl was present in more than 71,000 overdose deaths in 2021.

Nationwide, other solutions to reduce overdose deaths are being tested at the state and local levels. At the end of 2021, New York City Opened the nation’s first legal supervised injection site, where drug users can do so in a clean environment with medical staff on hand to administer naloxone or other drugs when necessary. Similar sites have been considered in Colorado And Massachusetts, California Governor Gavin Newsom Recently vetoed a similar effort in his state.

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