FDA approves higher dose naloxone nasal spray for treating opioid overdose
The FDA today announced approval of a higher dose naloxone hydrochloride nasal spray product for opioid overdose treatment.
The product delivers 8 mg of naloxone, whereas the previous versions delivered 2 mg and 4 mg.
“Today’s action meets another critical need in combatting opioid overdose,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most.”
The FDA granted the approval to Hikma Pharmaceuticals through the 505(b)(2) approval pathway under the Federal Food, Drug, and Cosmetic Act. The administration noted that its finding of safety and effectiveness for naloxone hydrochloride (Narcan) supported the current approval for the higher-dose product, called Kloxxado. Further, Hikma Pharmaceuticals provided Kloxxado-specific pharmacokinetic data that demonstrated the drug’s safety and efficacy for its approved use.
"The FDA recognized that the drug overdose epidemic is ever-changing, and government regulators must be agile to ensure that patients at risk of an opioid-related overdose have effective medication to help save their lives,” Patrice Harris, MD, MA, chair of the AMA Opioid Task Force and immediate past president of the AMA, said in a release. “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. 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," Harris added.
AMA. AMA statement on FDA decision on naloxone nasal spray. Accessed April 30, 2021.
FDA. FDA approves higher dosage of naloxone nasal spray to treat opioid overdose. Accessed April 30, 2021. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-higher-dosage-naloxone-nasal-spray-treat-opioid-overdose.