Kloxxado™ (naloxone hydrochloride) nasal spray is now available for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients.
Kloxxado is an opioid antagonist that delivers 8mg of naloxone hydrochloride per spray into the nasal cavity compared with the previously approved 2mg and 4mg naloxone nasal spray products currently on the market. Kloxxado is intended for immediate administration as emergency therapy in settings where opioids may be present.
In April 2021, the Food and Drug Administration (FDA) approved Kloxxado through the 505(b)(2) approval pathway based on the safety and efficacy of naloxone hydrochloride (Narcan injection). The approval was also supported by Kloxxado-specific pharmacokinetic data, which established the safety and efficacy of the product.
Kloxxado is supplied in a carton containing 2 single-dose nasal spray devices; each device delivers 8mg of naloxone hydrochloride per 0.1mL spray. The device is ready to use and does not need to be primed or tested prior to administration.
If a patient does not respond or responds and then relapses into respiratory depression, additional doses of Kloxxado should be administered using a new nasal spray, alternating nostrils with each dose. Each device contains a single-dose of naloxone and cannot be reused.
- Hikma announces US launch of Kloxxado™ (naloxone HCl) nasal spray 8mg. News release. Hikma Pharmaceuticals USA Inc. Accessed August 4, 2021. https://www.prnewswire.com/news-releases/hikma-announces-us-launch-of-kloxxado-naloxone-hcl-nasal-spray-8mg-301347670.html.
- Kloxxado [package insert]. Columbus, OH: Hikma Pharmaceuticals USA Inc; 2021.