The FDA approved the first over-the-counter naloxone nasal spray (Narcan), a drug that can quickly reverse the effects of an opioid overdose and save lives.
Overdoses killed more than 100,000 people in a 12-month period ending in October 2022, according to the FDA.
US Overdose Crisis
Making naloxone more widely available is viewed as a critical tactic for combating the nationwide overdose issue, which has been connected to more than 100,000 deaths in the United States each year. The bulk of those deaths is linked to opioids, including strong synthetic opioids like fentanyl, which can require numerous doses of naloxone to reverse.
Even before the FDA’s intervention, pharmacists were able to sell naloxone without a prescription since officials in every state permitted it. However, it is not available in every pharmacy. Buyers must also pay for the medication, either through an insurance co-pay or the full retail price. The price varies, but two doses of Narcan typically cost roughly $50.
The medicine is also supplied by community organizations that support drug users, though it is not readily available to everyone who requires it. Emergent has not disclosed pricing, and it is unclear if insurers will continue to cover it as a prescription drug if it is available without a prescription.
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What Does FDA Approval Of Narcan Imply?
According to the corporation, Narcan will be available over the counter by late summer. Other naloxone brands and injectable formulations are not now available over the counter, although they may be short.
As part of an FDA mandate, several producers of generic naloxone that is created similarly to Narcan will now be compelled to file applications to switch their medications over the counter. Harm Reduction Therapeutics Inc., which is funded by OxyContin maker Purdue Pharma, has already applied to the FDA to sell its version of spray naloxone without a prescription.
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