What is the difference between Narcan (naloxone HCI) 4 mg and Kloxxado? Kloxxado contains 8 mg of naloxone per spray, whereas Narcan contains 4 mg per spray. Both products come with two devices per box.
Question: What does Naloxone do to the body?
Answer: Naloxone is an opioid antagonist. This means that it attaches to opioid receptors and reverses and blocks the effects of other opioids. Naloxone can quickly restore normal breathing to a person if their breathing has slowed or stopped because of an opioid overdose.
Q: What does Naloxone do to a person who has no drugs in their system?
A: Nothing. Naloxone will only work if a person has opiates in their system. It will not work with other drugs. A person CANNOT get high from using Naloxone. Naloxone will not harm someone who does not have opioids in their system. If someone is having a medical emergency other than an opioid overdose - such as a diabetic coma or cardiac arrest - giving them Naloxone will generally not have any effect or cause them additional harm.
Q: When was Kloxxado approved by the FDA?
A: Hikma Pharmaceutical announced, on April 30, 2021.
Q: Is it better to administer 8mg Kloxxado to someone who is overdosing/poisoned by opioids than administering 4mg Narcan?
A: Per the CDC:
During March 2022–August 2023, New York State Department of Health (NYSDOH) supplied some New York State Police (NYSP) troops with 8-mg intranasal naloxone; other troops continued to receive 4-mg intranasal naloxone to treat suspected opioid overdose.
No significant differences were observed in survival, mean number of naloxone doses administered, prevalence of most post naloxone signs and symptoms, post naloxone anger or combativeness, or hospital transport refusal among 4-mg and 8-mg intranasal naloxone recipients.
Persons who received the 8-mg intranasal naloxone product had 2.51 times the risk for opioid withdrawal signs and symptoms, including vomiting, then did those who received the 4-mg intranasal naloxone product (95% CI = 1.51–4.18).
This initial study suggests no benefits to law enforcement administration of higher-dose naloxone were identified.
More research is needed to guide public health agencies in considering whether 8-mg intranasal naloxone confers additional benefits for community organizations.
One retrospective study of community members noted that the majority administered ≥2 doses in responding to suspected overdoses. However, no real-world quantitative data suggest that 4-mg intranasal naloxone is ineffective at reversing such overdoses. *
*At the time of this writing (article by the CDC), FDA has not approved intranasal naloxone doses >4 mg/0.1 mL for over-the-counter sales and has approved a lower dose (3 mg/0.1 mL) for such sales. https://www.fda.gov/news-events/press-announcements/fda-approves-second-over-counter-naloxone-nasal-spray-produc
Summary
What is already known about this topic?
In 2021, the Food and Drug Administration approved an 8-mg intranasal naloxone product, with twice the amount in the usual 4-mg dose; no data on use of this product in probable opioid overdoses are available.
What is added by this report?
Among recipients of 4-mg or 8-mg intranasal naloxone administered by law enforcement, no differences were observed in survival, the number of doses received, prevalence of most post naloxone signs and symptoms, combativeness, or hospital transport refusal; 8-mg product recipients had a significantly higher prevalence of opioid withdrawal signs and symptoms than did 4-mg product recipients.
What are the implications for public health practice?
No benefits to administration of 8-mg intranasal naloxone compared with 4-mg product were found. More data are needed to determine whether higher-dose intranasal naloxone would provide added benefits.
Resources:
Naloxone DrugFacts | National Institute on Drug Abuse (NIDA) (nih.gov)