FDA authorizes sale of Narcan Nasal Spray without prescription

Naloxone is a medicine that quickly reverses the effects of an opioid overdose, and is generally acknowledged as the standard treatment for this condition. This decision allows consumers to directly purchase life-saving medication from various retail outlets, including drug stores, grocery stores, gas stations and online stores.

The FDA states it has taken various measures to facilitate access to naloxone products. In November 2022, the agency announced its preliminary assessment that certain naloxone products, such as the one approved today, including the one approved today, could be safe and effective for OTC use, and encouraged manufacturers to submit applications for OTC naloxone products.

In 2019, the FDA also developed, tested, and validated a model naloxone Drug Facts Label (DFL) with user-friendly pictograms to encourage manufacturers to seek approval of OTC naloxone products. The approved application was supported by the model Drug Facts Label (DFL) and the results of a simulated use Human Factors validation study that assessed whether users could safely and effectively use all the product components as intended.

The FDA warns that the use of Narcan nasal spray in opioid-dependent individuals may result in severe opioid withdrawal symptoms. These symptoms may include body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.