Skip to Content

FDA Approves Higher-Dose Naloxone Hydrochloride Nasal Spray

MONDAY, May 3, 2021 -- The U.S. Food and Drug Administration approved use of a higher dose of naloxone hydrochloride nasal spray for treating opioid overdose, the agency announced Friday.

The newly approved dose of 8 mg provides an additional option to the 2-mg and 4-mg doses already approved for use.

In a statement, the FDA said this decision follows other steps the agency has taken to improve naloxone product availability, including the requirement that drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder add recommendations about naloxone to prescribing information and the extension of the shelf life of naloxone nasal spray from two to three years.

Naloxone may cause opioid withdrawal in patients who are opioid-dependent. Withdrawal symptoms include body aches, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.

"By approving a higher dose of naloxone hydrochloride nasal spray product to treat opioid overdose, the FDA is making sure the overdose-reversing drug is potent enough to counteract the increasingly lethal and illicitly manufactured fentanyl and fentanyl analogs," Patrice Harris, M.D., chair of the American Medical Association Opioid Task Force, said in a statement. "Now, we must make sure that the new version of naloxone is placed on the lowest cost-sharing tier with low or no cost-sharing and also available in pharmacies. Communities are looking for tools to respond to the epidemic of drug overdoses, and the FDA action today adds a powerful one."

Approval was granted to Hikma Pharmaceuticals through the 505(b)(2) approval pathway under the Federal Food, Drug, and Cosmetic Act.

More Information

AMA Statement

© 2021 HealthDay. All rights reserved.

Read this next

Factors ID'd Putting Youth on High-Risk Trajectory After First Opioid Rx

THURSDAY, May 6, 2021 -- High- and low-risk trajectories are identifiable for youth following their first opioid prescription, according to a study published online April 22 in...

Supply Steady for Existing Patients Receiving Opioids During COVID-19

FRIDAY, April 30, 2021 -- Existing patients receiving opioid analgesics and buprenorphine for opioid use disorder have continued to receive medications during the COVID-19...

Younger Age at First Drug Use Tied to Faster Transition to Substance Use Disorder

FRIDAY, April 23, 2021 -- Younger age at drug initiation is associated with a faster transition to substance use disorder (SUD), according to a research letter published online...

More News Resources

Subscribe to our Newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.