Health Canada Approves Hikma's KLOXXADO® 8 mg Nasal Spray for Opioid Overdose Treatment
Key Insights
Health Canada has approved KLOXXADO® (naloxone HCl) Nasal Spray 8 mg for treating known or suspected opioid overdoses in adults, providing a higher-dose alternative to existing treatments.
Emergent BioSolutions will lead commercial efforts in Canada under a six-year agreement with Hikma, with the product expected to be available by prescription as early as 2026.
The approval comes as Canada faces an ongoing opioid crisis with 22 lives lost daily to overdoses in 2023, though expanded naloxone distribution has contributed to decreasing death rates in recent years.
Hikma Pharmaceuticals PLC has announced that Health Canada has approved KLOXXADO® (naloxone HCl) Nasal Spray 8 mg for the treatment of known or suspected opioid overdose (search) in adult patients. The approval marks an important milestone in expanding treatment options for opioid overdose emergencies in Canada.
KLOXXADO® delivers 8 mg of naloxone hydrochloride per spray in a ready-to-use nasal device, designed to reverse the effects of opioid overdose (search) by antagonizing opioid effects through competition for the same receptor sites.
New Option in Canada's Fight Against Opioid Crisis
The approval comes at a critical time as Canada continues to battle a severe opioid crisis. According to Health Canada data, 22 lives were lost each day to opioid overdose (search) fatalities in 2023, highlighting the urgent need for effective interventions.
"The approval of KLOXXADO® Nasal Spray will provide Canadian patients, friends and family members – as well as the healthcare and first responder communities – with an important treatment option for victims suffering from opioid overdose (search)," said Hafrun Fridriksdottir, President of Hikma Generics.
Fridriksdottir added, "According to distinguished medical and health organizations, widely prescribing and distributing naloxone plays a vital role in the fight against opioid overdose (search). With the growing threat of stronger, more deadly synthetic opioids like illicit fentanyl, intranasal naloxone is an essential tool in that fight."
Commercial Partnership with Emergent BioSolutions
Under a recently established six-year commercial agreement, Emergent BioSolutions (Emergent) will market and sell KLOXXADO® Nasal Spray in Canada. Hikma will continue manufacturing the product at its Columbus, Ohio facility while Emergent takes responsibility for all North American product sales and marketing.
Following the approval, Emergent will engage with Canadian agencies, private payers, and provincial formularies to make KLOXXADO® available by prescription as early as 2026.
Paul Williams, SVP and products business head at Emergent, emphasized the importance of this approval: "Across Canada, 22 innocent lives were lost each day to an opioid overdose (search) fatality in 2023, which is why meeting the needs of our patients, communities and customers is so critical."
Williams noted that NARCAN® Nasal Spray has been an important 4 mg naloxone option in Canada for years, and believes "KLOXXADO® Nasal Spray 8 mg may be beneficial for those who choose to administer a higher dose of naloxone."
Impact on Opioid Overdose Prevention
Recent data from Health Canada shows a national decrease in overdose deaths for the third consecutive year. The Minister of Mental Health and Addictions and Associate Minister of Health has cited expanded naloxone distribution as one of several factors potentially contributing to this reduction.
The availability of naloxone kits has helped reverse thousands of overdoses across Canada. With the approval of KLOXXADO® Nasal Spray alongside the existing NARCAN® Nasal Spray, healthcare providers will now have more options to tailor opioid overdose (search) reversal treatment for specific patients and communities.
Clinical Information and Usage
KLOXXADO® is indicated for emergency use to reverse known or suspected opioid overdose (search) manifested by respiratory and/or central nervous system depression. The product is not a substitute for emergency medical care, and users are instructed to always seek immediate medical help when administering KLOXXADO®.
Signs and symptoms of opioid overdose (search) that may indicate the need for KLOXXADO® include:
- Trouble breathing or not breathing
- Extreme drowsiness
- Pale and clammy skin
- Slow or no heartbeat
- Passing out
- Inability to be awakened by touch, shaking, or shouting
- Very small pupils (pinpoint)
Family members, caregivers, or others who may need to use KLOXXADO® in an emergency should familiarize themselves with the product's storage location and administration method before an emergency occurs.
Safety Considerations
Like other naloxone products, KLOXXADO® can cause sudden and severe opioid withdrawal symptoms, including body aches, diarrhea, rapid heartbeat, fever, runny nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, stomach cramps, weakness, and high blood pressure.
The product is not indicated for pediatric use. In clinical studies, side effects reported in some subjects included abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope.
Market Outlook
The approval of KLOXXADO® represents an important addition to Canada's arsenal against opioid overdoses. As synthetic opioids like fentanyl continue to pose significant public health threats, having multiple naloxone delivery options with different dosage strengths may help address the varying potency of illicit opioids encountered in overdose situations.
Healthcare professionals emphasize that while naloxone products are critical life-saving tools, they should be viewed as part of a comprehensive approach to addressing the opioid crisis, which includes prevention, treatment, and harm reduction strategies.