FDA Approves Opioid Overdose Drug Narcan for Over-the-Counter-Sales

The FDA has given the green light for Narcan, a medication used to reverse the effects of opioid overdose, to be sold over the counter without requiring prescription in pharmacies across the United States. Narcan, which is manufactured by Emergent BioSolutions, a pharmaceutical firm based in Maryland, comes in the form of nasal spray and was initially approved by the FDA as a prescription drug in 2015. Its active ingredient is naloxone, a substance that binds to opioid receptors in the brain and effectively reverses the dangerous effects of opioid intoxication such as coma and respiratory depression.

The nasal spray format of Narcan can be administered either by trained or untrained users after a simple demonstration. Its approval for over-the-counter sales increases the accessibility of the drug in various locations like drug and convenience stores, grocery stores, gas stations, and online platforms where people can freely buy it at an affordable price. The FDA’s decision is expected to help reduce opioid overdose deaths in the country by making naloxone easily available.

Aside from Narcan, there are other forms of naloxone available in the market. The auto-injection must-have device called Evzio is already filled with the medication and can be easily injected into the outer thigh of a patient by any untrained user, similar to an EpiPen used for allergic reactions. For the traditional naloxone, a professional training is necessary for users and comes in different forms apart from the Nasal spray. Professionals can administer it through injecting it into the muscles, veins, or under the skin.

The FDA emphasized that with the approval of Narcan, there would be a requirement for revised labeling from manufacturers of generic naloxone nasal sprays, a process that would require manufacturers to submit a supplement to their applications to obtain over-the-counter status. Brand-name naloxone nasal spray products will be reviewed on a case-by-case basis as the FDA approaches the process.

Prior to the over-the-counter approval for Narcan, all fifty states and the District of Columbia had passed some legislative measures that allowed people to purchase naloxone without a prescription. In states like New York and Pennsylvania, police officers, firefighters, and emergency medical teams have been trained and encouraged to carry naloxone to prevent loss of lives due to opioid overdose.

The rise of opioid drug overdoses is a significant public health problem in the United States, with over 101,750 reported fatal overdose cases in the country in the twelve-month period ending in October 2022. The proliferation of synthetic opioids like fentanyl, which is stronger than morphine and heroin, is a major driver of this pressing public health issue.

Source: DEA