Health Canada Approves Hikma’s Kloxxado Nasal Spray for Opioid Overdose

Hikma Pharmaceuticals PLC (Hikma, Group), the multinational generic pharmaceutical company, announces the approval of Kloxxado (naloxone HCl) nasal spray 8 mg, by Health Canada for the treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult patients.

Kloxxado delivers 8 mg of naloxone hydrochloride per spray in a ready to use nasal spray to reverse the effects of opioid overdose.

“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,” said Hafrun Fridriksdottir, president, Hikma Generics. “According to distinguished medical and health organizations, widely prescribing and distributing naloxone plays a vital role in the fight against opioid overdose. With the growing threat of stronger, more deadly synthetic opioids like illicit fentanyl, intranasal naloxone is an essential tool in that fight.”

Kloxxado nasal spray will be marketed and sold in Canada by Emergent BioSolutions (Emergent) under the terms of a recent six-year commercial agreement with Hikma, whereby Emergent will be responsible for all North America product sales and marketing. Hikma will continue producing Kloxxado nasal spray in its Columbus, Ohio manufacturing facility and will provide it to Emergent as its exclusive commercial partner. Following the approval of Kloxxado nasal spray, Emergent will engage Canadian agencies, private payers and provincial formularies, and aims to make Kloxxado available via prescription as early as 2026.

“Across Canada, 22 innocent lives were lost each day to an opioid overdose fatality in 2023, which is why meeting the needs of our patients, communities and customers is so critical,” said Paul Williams, SVP and products business head, Emergent. “Narcan nasal spray has been an important 4 mg naloxone option to reduce opioid poisonings in Canada for years, and we believe Kloxxado nasal spray 8 mg may be beneficial for those who choose to administer a higher dose of naloxone. We are encouraged by the Health Canada approval and believe broadening our opioid antagonist offerings is a much-needed effort to help save lives from tragic opioid poisonings.”

Recent data reported by Health Canada shows a national decrease in overdose deaths for the third year in a row, with the Minister of Mental Health and Addictions and Associate Minister of Health citing expanded naloxone distribution as one of several factors that could be contributing to this reduction. The availability of naloxone kits has helped to reverse thousands of overdoses across Canada, and now, the approval of Kloxxado nasal spray will continue to improve access and help save lives. Alongside Narcan nasal spray, prescription Kloxxado nasal spray will allow for a tailored approach to opioid overdose reversal treatment for specific patients and communities.

Naloxone hydrochloride is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites. Administration of naloxone hydrochloride reverses the effects of opioids, including respiratory depression, sedation and hypotension. Naloxone has a long history of safe use as the standard of care in the United States for reversing opioid overdoses.

Kloxxado is indicated for the treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult patients.

Kloxxado is not a substitute for emergency medical care.

Kloxxado is a registered trademark of Hikma Pharmaceuticals USA Inc.

Narcan is a registered trademark of Emergent Operations Ireland Limited.

Narcan nasal spray is a pure opioid antagonist indicated for emergency use to reverse known or suspected opioid overdose, as manifested by respiratory and/or severe central nervous system depression.

While Narcan nasal spray can be administered by a non-health care professional, it is not intended to be a substitute for professional medical care. Always call 911 as soon as an opioid overdose is suspected, before administering Narcan nasal spray.

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