Kloxxado ™ (naloxone hydrochloride) nasal spray is now available for the emergency treatment of known or suspected opioid overdose manifested by respiratory and / or central nervous system depression in adult and pediatric patients.
Kloxxado is an opioid antagonist that delivers 8 mg of naloxone hydrochloride per spray into the nasal cavity compared to the previously approved 2 mg and 4 mg naloxone nasal spray products currently on the market. Kloxxado is intended for immediate administration as emergency therapy in situations where opioids may be present.
In April 2021, the Food and Drug Administration (FDA) approved Kloxxado via the 505 (b) (2) pathway based on the safety and effectiveness of naloxone hydrochloride (Narcan injection). The approval was also supported by Kloxxado-specific pharmacokinetic data demonstrating the safety and efficacy of the product.
Kloxxado comes in a box with 2 single dose nasal sprays; Each device delivers 8 mg of naloxone hydrochloride per 0.1 ml of spray. The device is ready to use and does not need to be prepared 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 with a new nasal spray, alternating with each dose into the nostrils. Each device contains a single dose of naloxone and cannot be reused.
- Hikma announces the launch of Kloxxado ™ (naloxone HCl) nasal spray 8 mg in the US. Press 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.
- closure [package insert]. Columbus, Ohio: Hikma Pharmaceuticals USA Inc; 2021.
This article originally appeared on MPR
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