FDA Approves First Generic Naloxone Nasal Spray

PUBLISHED: Apr 24, 2019
Relevant to: All Healthcare Organizations

The US Food and Drug Administration has granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, to reverse the effects of an opioid overdose.

According to the Centers for Disease Control and Prevention, almost 400,000 people died from an opioid overdose from 1999 to 2017, and on average, more than 130 Americans die every day from overdoses involving opioids, a class of drugs that include prescription medications such as fentanyl, oxycodone, hydrocodone and morphine, as well as illegal drugs such as heroin or drugs sold as heroin. Drugs like heroin often contain fentanyl or derivatives of fentanyl.

As part of the U.S. Department of Health and Human Services’ ongoing efforts to combat the opioid crisis and expand the use of naloxone, in April 2017, the Department announced its 5-Point Strategy to Combat the Opioids Crisis. Those efforts include better addiction prevention, treatment, and recovery services; better data; better pain management; better targeting of overdose reversing drugs; and better research. One of the ways the FDA is working to increase access to this life-saving treatment is through the approval of generic naloxone products. As part of HHS’ public health emergency to address the ongoing opioid crisis, the FDA will grant priority review to all abbreviated new drug applications for products indicated for the emergency treatment of known or suspected opioid overdose.

The FDA also remains focused on several additional priorities to address the opioid crisis, including: decreasing exposure to opioids and preventing new addiction; fostering the development of novel pain treatment therapies; supporting treatment of those with opioid use disorder; and improving enforcement and assessing benefit-risk.

Naloxone nasal spray does not require assembly and delivers a consistent, measured dose when used as directed. This product can be used for adults or children and is easily administered by anyone, even those without medical training. The drug is sprayed into one nostril while the patient is lying on his or her back and can be repeated if necessary.

The use of naloxone nasal spray in patients who are opioid-dependent may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate (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.

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