What are ZIMHI™ and Kloxxado™?
New Naloxone Products Approved by the FDA
The Steve Rummler HOPE Network is committed to community education and with the recent buzz around new naloxone products, such as ZIMHI™ and Kloxxado™, we’d like to take a moment to break down the information we know so far.
What is ZIMHI™?
ZIMHI™ is a trademarked injectable format of naloxone, containing 5 mg/0.5 mL naloxone hydrochloride solution in a single-dose, pre-filled syringe. This is a substantially higher concentration that most injectable naloxone (for reference, naloxone used in SRHN kits contains 0.4mg of medication per 1mL vial).
ZIMHI™ was approved by the FDA in October 2021 for emergency treatment of opioid overdose for adult and pediatric patients, and is manufactured by US WorldMeds. This product is now available to public interest groups, including non-profits, first responder agencies and harm reduction groups, and can be ordered through zimhidirect.com.
What is Kloxxado™?
Similar to NARCAN®, Kloxxado™ is a trademarked nasal spray form of naloxone. With each spray containing 8 mg of naloxone, Kloxxado™ delivers twice as much medication as NARCAN® (naloxone HCl) Nasal Spray (4mg per applicator).
Kloxxado™ was approved by the FDA on April 30, 2021 for emergency treatment of opioid overdose for adult and pediatric patients, and is manufactured by Hikma Pharmaceuticals.
Since 2013, synthetic opioids, like fentanyl, have been a driving factor of opioid overdoses because of their high potency and wide distribution. Because synthetic opioids can require multiple doses of IM naloxone or NARCAN® to reverse an overdose, ZIMHI™ and Kloxxado™ may seem like great additions to the market, as both contain higher concentration than most traditional naloxone products.
Other Considerations
Some questions have been raised about the effects a high dose naloxone product may have on withdrawal symptoms experienced by individuals revived from an overdose. Precipitated withdrawal may occur, triggering intense symptoms such as diarrhea, vomiting, pain, and anxiety. Think of precipitated withdrawal as slamming on the brakes, compared to slowly rolling to a stop. Higher doses of naloxone have been shown to make withdrawal symptoms worse, but can be quicker at pulling people out of an overdose, especially when multiple doses of a traditional product may be required to fully displace synthetic opioids in the system.
Corey Davis, director of the Harm Reduction Legal Project states that the onset of withdrawal is a very real worry for recipients of harm reduction services: “none of them are saying this is something we need, and a lot of them have these concerns that it is going to make people sicker.” Some individuals may prefer to continue using smaller dosage products incrementally to reduce the risk of severe withdrawal symptoms.
What’s Next?
Unfortunately it can be difficult to find independent studies into the effectiveness of newer products, as they tend to be limited in the immediate period following release. Since these types of higher doses formulations have only been on the market for a few months, it is too soon to say how relative risks and benefits will be measured.
As a network we strive to keep our community safe and knowledgeable and will commit to updating everyone as we continue to learn more about these products. In the meantime, our mission and recommendations remain the same: If you suspect someone is experiencing an opioid overdose, call 911 and administer any kind of naloxone you have right away.
If you interested in receiving a standard IM naloxone kit from SRHN, check out our I Want Naloxone Training page.