Higher Dosage of Naloxone Nasal Spray Approved by FDA for Treating Opioid Overdose

Officials with the FDA have approved an 8 mg dose naloxone hydrochloride nasal spray (Kloxxado; Hikma Pharmaceuticals) for the emergency treatment of known or suspected opioid overdose in adult and pediatric patients.¹ This product is a higher dosage of naloxone hydrochloride than the 2 mg and 4 mg dosage products previously approved by the FDA.²

Naloxone hydrochloride is an opioid antagonist that reverses the effects of opioids, including respiratory depression, sedation, and hypotension. According to Hikma, the drug has a long history of safe use as the standard of care for reversing opioid overdoses.¹

Naloxone hydrochloride can be administered by individuals with or without medical training to help reduce opioid overdose deaths. If administered quickly, the drug can counter the opioid overdose effects, usually within minutes. According to the FDA, a higher dose of naloxone provides an additional option in the treatment of opioid overdoses.²

According to Hikma, widely prescribing and distributing naloxone may play a vital role in the fight against opioid overdose. With the increasing prevalence of illicitly manufactured synthetic opioids, a higher dose of naloxone may be required to revive a patient.¹

The use of naloxone in patients who are opioid-dependent may result in opioid withdrawal characterized by 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.²

According to Hikma, the company expects its naloxone hydrochloride nasal spray 8 mg to be available in the second half of 2021.¹

REFERENCES

1. Hikma announces US FDA approval of KLOXXADO TM (naloxone hydrochloride) nasal spray 8mg [news release]. April 30, 2021; Hikma Pharmaceuticals. Accessed May 3, 2021. https://www.hikma.com/newsroom/article-i5120-hikma-announces-us-fda-approval-of-kloxxado-tm-naloxone-hydrochloride-nasal-spray-8mg/
2. FDA Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid Overdose [news release]. April 30, 2021; FDA. Accessed May 3, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-higher-dosage-naloxone-nasal-spray-treat-opioid-overdose