According to Emergent BioSolutions, Health Canada has approved Hikma Pharmaceuticals’ Kloxxado naloxone nasal spray 8 mg for the treatment of opioid overdose. In January 2025, Emergent announced that it was acquiring US and Canadian rights to Kloxxado, which has been approved in the US since 2021. Emergent, which already markets Narcan naloxone nasal spray 4 mg in Canada and in the US, says that its goal is to launch Kloxxado in Canada in 2026.
Hikma Generics President Hafrun Fridriksdottir commented, “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. 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.”
Emergent Senior VP and Products Business Head Paul Williams said, “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.”
Read the Emergent Biosolutions press release
