FDA Approves Over-the-Counter Sale of Opioid Overdose-Reversing Drug Narcan

Narcan to be Sold Over-the-Counter Without a Prescription

In an effort to combat the ongoing opioid epidemic in the United States, the Food and Drug Administration (FDA) has approved the nasal spray Narcan to be sold over-the-counter without a prescription. Emergent BioSolutions, the pharmaceutical company that produces Narcan, plans to make it available on store shelves and online retailers by late summer.

Previously, those who wanted to buy Narcan had to obtain it at a pharmacy with a prescription or through harm reduction groups offering free naloxone. However, the new FDA approval can make the medication more accessible and save lives. It is important to note that the specific dose approved for over-the-counter sales is the 4 milligram (mg) naloxone hydrochloride nasal spray, and other formulations and dosages of the drug still require a prescription.

How Narcan Can Help Combat Opioid Epidemic

Narcan, also known as naloxone, can reverse the effects of an opioid overdose and is considered the standard treatment for opioid overdose. The US has seen 101,751 reported fatal overdoses in the 12-month period ending in October, largely driven by synthetic opioids such as illicit fentanyl. With wider availability of Narcan through over-the-counter sales, there is hope that lives can be saved and less fatalities will occur due to overdoses.

Previous FDA Approval for Prescription Narcan

The FDA first approved Narcan nasal spray in 2015 as a prescription drug. The manufacturer provided data demonstrating that the drug was safe and effective for use as directed in its proposed labeling, and consumers could understand how to use the drug safely and effectively with supervision from healthcare professionals.

Benefits of Over-the-Counter Sale of Narcan

The approval of over-the-counter Narcan requires a change in the labeling for the currently approved 4mg generic naloxone nasal spray products that rely on Narcan as their reference listed drug product. The FDA has taken a series of measures to help facilitate access to naloxone products and combat the overdose crisis. Making the drug available over-the-counter could save more lives, especially for young people and families.

Concerns Over the Cost

While the over-the-counter version of Narcan will be packaged in a larger box with images and detailed instructions to help people administer the drug more easily, concerns have been raised about the cost of the medication. The average price of a two-dose box of prescription-only Narcan is around $130. The timeline for availability and price of this over-the-counter product is determined by the manufacturer.

Final Thoughts

Overall, the FDA’s approval of Narcan for over-the-counter sale without a prescription is a step forward in combating the opioid epidemic in the United States. With easier access to this life-saving medication, more lives can be saved and less fatalities will occur due to overdoses. While concerns regarding cost still linger, it is important to note that wider availability of Narcan through over-the-counter sales is an essential tool in addressing opioid overdoses and its related fatalities.

Image Source: Wikimedia Commons