FDA Approves First Generic Naloxone Nasal Spray


Unlike injectable versions, naloxone nasal spray may be administered outside a health care setting by anyone, regardless of medical training.


The US Food and Drug Administration (FDA) has approved the first generic naloxone hydrochloride nasal spray that can mitigate the effects of an opioid overdose.

This is the first generic nasal spray of naloxone, which can be used outside of a health care setting by those without medical training. The name-brand spray, Narcan, was approved by the FDA in November 2015. Previously, there have been generic versions of injectable naloxone products that are used strictly in medical settings.

The ongoing opioid crisis in the United States has led to the scrutiny of pharmaceutical and prescribing practices and has put pressure on public health agencies to implement policies to help keep people from becoming dependent on opioids, to support medication-assisted treatment (MAT) for patients with opioid use disorder, and to prevent deaths from overdoses.

"In the wake of the opioid crisis, a number of efforts are underway to make this emergency overdose reversal treatment more readily available and more accessible. In addition to this approval of the first generic naloxone nasal spray, moving forward we will prioritize our review of generic drug applications for naloxone," said Douglas Throckmorton, MD, deputy center director for regulatory programs in the FDA's Center for Drug Evaluation and Research.

Throckmorton added that the FDA will also help manufacturers who seek approval for over-the-counter naloxone products. Additionally, he said that the FDA is considering whether naloxone should be prescribed alongside opioid prescriptions in an effort to reduce overdoses.

The FDA is also granting priority review to all abbreviated new drug applications—those applications for generics—for products indicated for the emergency treatment of known or suspected opioid overdoses.

Use of naloxone nasal spray in patients who are dependent on opioids may cause opioid withdrawal symptoms including body aches, diarrhea, tachycardia, fever, runny nose, sneezing, goose bumps (piloerection), sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.

“We're taking many steps to improve availability of naloxone products, and we're committed to working with other federal, state and local officials as well as health care providers, patients and communities across the country to combat the staggering human and economic toll created by opioid abuse and addiction," said Throckmorton.

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