Hikma announces Health Canada approval of KLOXXADO® (naloxone HCl) Nasal Spray 8 mg
Hikma Pharmaceuticals announces Health Canada's approval of KLOXXADO® (naloxone HCl) Nasal Spray 8 mg for treating known or suspected opioid overdose in adult patients. The treatment will be marketed in Canada by Emergent BioSolutions under a six-year commercial agreement, with availability expected by 2026.
The 8 mg naloxone hydrochloride nasal spray offers a higher-dose alternative to the existing 4 mg NARCAN® Nasal Spray. This approval comes as Canada faces significant opioid-related challenges, with 22 lives lost daily to overdoses in 2023. However, recent Health Canada data shows a national decrease in overdose deaths for the third consecutive year, partially attributed to expanded naloxone distribution.
Under the agreement, Emergent will handle North American sales and marketing, while Hikma will manufacture the product at its Columbus, Ohio facility. Emergent plans to engage with Canadian agencies, private payers, and provincial formularies to ensure widespread availability.
Hikma Pharmaceuticals annuncia l'approvazione da parte di Health Canada dello KLOXXADO® (naloxone HCl) Spray Nasale da 8 mg per il trattamento di overdose da oppioidi note o sospette in pazienti adulti. Il trattamento sarà commercializzato in Canada da Emergent BioSolutions sotto un accordo commerciale di sei anni, con disponibilità prevista entro il 2026.
Lo spray nasale di naloxone cloridrato da 8 mg offre un'alternativa a dose più alta rispetto al già esistente spray nasale NARCAN® da 4 mg. Questa approvazione arriva mentre il Canada affronta sfide significative legate agli oppioidi, con 22 vite perse quotidianamente a causa di overdose nel 2023. Tuttavia, dati recenti di Health Canada mostrano una diminuzione nazionale dei decessi per overdose per il terzo anno consecutivo, attribuibile in parte all'espansione della distribuzione di naloxone.
In base all'accordo, Emergent gestirà le vendite e il marketing in Nord America, mentre Hikma produrrà il prodotto presso il suo stabilimento di Columbus, Ohio. Emergent prevede di collaborare con agenzie canadesi, pagatori privati e formulari provinciali per garantire una disponibilità diffusa.
Hikma Pharmaceuticals anuncia la aprobación por parte de Health Canada del KLOXXADO® (naloxona HCl) en spray nasal de 8 mg para el tratamiento de sobredosis de opioides conocidas o sospechadas en pacientes adultos. El tratamiento será comercializado en Canadá por Emergent BioSolutions bajo un acuerdo comercial de seis años, con disponibilidad esperada para 2026.
El spray nasal de naloxona clorhidrato de 8 mg ofrece una alternativa de dosis más alta al spray nasal NARCAN® de 4 mg que ya existe. Esta aprobación se produce en un momento en que Canadá enfrenta desafíos significativos relacionados con los opioides, con 22 vidas perdidas diariamente por sobredosis en 2023. Sin embargo, datos recientes de Health Canada muestran una disminución nacional en las muertes por sobredosis por tercer año consecutivo, atribuida en parte a la expansión de la distribución de naloxona.
Según el acuerdo, Emergent se encargará de las ventas y el marketing en América del Norte, mientras que Hikma fabricará el producto en su planta de Columbus, Ohio. Emergent planea colaborar con agencias canadienses, pagadores privados y formularios provinciales para garantizar una disponibilidad generalizada.
Hikma Pharmaceuticals는 성인 환자의 알려진 또는 의심되는 아편유사제 과다복용 치료를 위한 KLOXXADO® (날록손 HCl) 8mg 비강 스프레이의 Health Canada 승인을 발표했습니다. 이 치료제는 Emergent BioSolutions에 의해 6년 상업 계약 하에 캐나다에서 판매될 예정이며, 2026년까지 공급될 것으로 예상됩니다.
8mg 날록손 염산 나잘 스프레이는 기존의 4mg NARCAN® 비강 스프레이보다 높은 용량 대안을 제공합니다. 이 승인은 2023년 하루에 22명이 과다복용으로 사망하는 등 캐나다가 아편유사제와 관련된 중대한 문제에 직면하고 있는 가운데 이루어졌습니다. 그러나 최근 Health Canada의 데이터에 따르면, 과다복용 사망자는 3년 연속으로 감소하고 있으며, 이는 부분적으로 날록손 배급의 확대에 기인하고 있습니다.
계약에 따라 Emergent는 북미의 판매 및 마케팅을 담당하고, Hikma는 오하이오주 콜럼버스에 있는 시설에서 제품을 제조할 것입니다. Emergent는 캐나다 기관, 민간 지불자 및 주 정부의 약제 목록과 협력하여 광범위한 가용성을 보장할 계획입니다.
Hikma Pharmaceuticals annonce l'approbation par Santé Canada du KLOXXADO® (naloxone HCl) en spray nasal de 8 mg pour le traitement des surdoses d'opioïdes connues ou suspectées chez les patients adultes. Le traitement sera commercialisé au Canada par Emergent BioSolutions dans le cadre d'un accord commercial de six ans, avec une disponibilité prévue d'ici 2026.
Le spray nasal de naloxone hydrochloride de 8 mg offre une alternative à dose plus élevée par rapport au spray nasal NARCAN® de 4 mg déjà existant. Cette approbation intervient alors que le Canada est confronté à des défis importants liés aux opioïdes, avec 22 vies perdues quotidiennement à cause de surdoses en 2023. Cependant, les données récentes de Santé Canada montrent une diminution nationale des décès par surdose pour la troisième année consécutive, en partie attribuée à l'élargissement de la distribution de naloxone.
Dans le cadre de l'accord, Emergent s'occupera des ventes et du marketing en Amérique du Nord, tandis que Hikma fabriquera le produit dans son établissement de Columbus, Ohio. Emergent prévoit de collaborer avec des agences canadiennes, des payeurs privés et des formulaires provinciaux pour garantir une disponibilité généralisée.
Hikma Pharmaceuticals gibt die Genehmigung von Health Canada für KLOXXADO® (Naloxon HCl) Nasenspray 8 mg zur Behandlung von bekannten oder vermuteten Opioidüberdosierungen bei erwachsenen Patienten bekannt. Die Behandlung wird in Kanada von Emergent BioSolutions unter einem sechsjährigen Handelsvertrag vermarktet, mit einer Verfügbarkeit, die bis 2026 erwartet wird.
Das 8 mg Naloxonhydrochlorid-Nasenspray bietet eine hochdosierte Alternative zum bestehenden 4 mg NARCAN® Nasenspray. Diese Genehmigung erfolgt zu einem Zeitpunkt, an dem Kanada mit erheblichen opioidbezogenen Herausforderungen konfrontiert ist, wobei im Jahr 2023 täglich 22 Leben durch Überdosierungen verloren gehen. Jüngste Daten von Health Canada zeigen jedoch einen nationalen Rückgang der Überdosierungstodesfälle im dritten Jahr in Folge, was teilweise auf die erweiterte Verteilung von Naloxon zurückzuführen ist.
Im Rahmen des Vertrags wird Emergent für den Vertrieb und das Marketing in Nordamerika verantwortlich sein, während Hikma das Produkt in seiner Einrichtung in Columbus, Ohio, herstellen wird. Emergent plant, mit kanadischen Agenturen, privaten Kostenträgern und provinziellen Formularen zusammenzuarbeiten, um eine weitreichende Verfügbarkeit sicherzustellen.
- Health Canada approval opens new market opportunity
- Six-year commercial agreement secures distribution channel
- Product addresses growing need with higher 8mg dose option
- Manufacturing already established at Columbus facility
- Launch delayed until 2026
- Requires additional approval processes with provincial formularies
- Faces existing competition from established NARCAN 4mg spray
Insights
Health Canada's approval of KLOXXADO® Nasal Spray 8 mg represents a meaningful portfolio expansion for Emergent BioSolutions in the Canadian opioid overdose reversal market. This development should be viewed in context of Emergent's existing presence with NARCAN® Nasal Spray (4mg), creating a more comprehensive product suite targeting different clinical scenarios.
The six-year commercial agreement with Hikma establishes a clear division of responsibilities - Hikma handles manufacturing while Emergent leads all North American marketing and sales as the exclusive commercial partner. This structure leverages Emergent's established distribution channels and market position while minimizing manufacturing investment requirements.
From a revenue perspective, investors should note the 2026 projected availability timeline, indicating this is a medium-term growth opportunity rather than an immediate revenue catalyst. The Canadian market context (22 daily opioid fatalities in 2023) suggests institutional demand, with expanded naloxone access cited as a factor in declining overdose rates for three consecutive years.
This approval strengthens Emergent's competitive positioning by allowing a differentiated approach with multiple dosage options. The higher-dose formulation addresses specific clinical needs where standard doses may be insufficient, potentially capturing additional market segments and enhancing the company's value proposition to Canadian healthcare systems.
Emergent BioSolutions will lead commercial launch efforts to increase access to intranasal naloxone and combat opioid overdose poisonings in Canada
LONDON and GAITHERSBURG, Md., March 20, 2025 (GLOBE NEWSWIRE) -- 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,1 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.2 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.
To learn more about Emergent’s commitment in Canada, visit this National Impact Map resource.
About Naloxone
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.
Enquiries
| Steve Weiss US Communications and Public Affairs | +1 732 788 8279 uscommunications@hikma.com | ||
| Assal Hellmer Vice President, Communications | mediarelations@ebsi.com | ||
About Hikma
Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (LEI:549300BNS685UXH4JI75) (rated BBB-/stable S&P and BBB-/positive Fitch)
Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across North America, the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 9,100 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: www.hikma.com
©2024 Hikma Pharmaceuticals PLC. All rights reserved.
About Emergent BioSolutions
At Emergent, our mission is to protect and save lives. For over 25 years, we’ve been at work preparing those entrusted with protecting public health. We deliver protective and life-saving solutions for health threats like smallpox, mpox, botulism, Ebola, anthrax and opioid overdose emergencies. To learn more about how we help prepare communities around the world for today’s health challenges and tomorrow’s threats, visit our website and follow us on LinkedIn, X, Instagram, Apple Podcasts and Spotify.
KLOXXADO® is a registered trademark of Hikma Pharmaceuticals USA Inc.
NARCAN® is a registered trademark of Emergent Operations Ireland Limited.
Important Safety Information for KLOXXADO® (naloxone HCl) Nasal Spray 8 mg
Contraindications
Hypersensitivity to naloxone hydrochloride or to any of the other ingredients in KLOXXADO®
Warnings and Precautions
- KLOXXADO® is used in adults to treat an opioid overdose. It can be used to reverse the effects of an
- overdose until medical help arrives. Use KLOXXADO® right away if you suspect an opioid overdose emergency, even if you are not sure, because an opioid overdose emergency can cause severe injury or death. Signs and symptoms of an opioid overdose may include:
- trouble breathing or not breathing
- extreme drowsiness
- pale and clammy skin
- slow or no heartbeat
- passing out
- unable to be woken up by touch, shaking of shoulders or shouting
- Very small pupils, like a pinpoint
- Family members, caregivers or other people who may have to use KLOXXADO® in an opioid overdose emergency should know where KLOXXADO® is stored and how to give KLOXXADO® before an opioid overdose emergency happens.
- Always seek immediate medical help when using KLOXXADO®. Rescue breathing or CPR (cardiopulmonary resuscitation) may be needed while waiting for emergency medical help.
- The signs and symptoms of an opioid overdose emergency can return after KLOXXADO® is given. If this happens, give another dose after 2 to 3 minutes, using a new KLOXXADO® device, in the other nostril, and watch the person closely until emergency medical help arrives.
- Do not use KLOXXADO® if you are allergic to naloxone hydrochloride or any of the ingredients in KLOXXADO®.
- KLOXXADO® can cause sudden and severe opioid withdrawal, the symptoms of which may include 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.
- KLOXXADO® is not indicated for pediatric use. In an emergency, if KLOXXADO® is administered to an infant because no other options are available, they may experience additional withdrawal symptoms such as: seizures, crying more than usual and overactive reflexes. These symptoms may be life-threatening if not treated right away. If KLOXXADO® is given to an infant, seek immediate medical help.
- Tell your doctor about all of your medical conditions before using KLOXXADO®, including if you have heart disease or any other heart problems, are pregnant or think you are pregnant, or are breastfeeding or plan to breastfeed.
- Tell your doctor about all of the medicines you take, including any prescription and over-the-counter medicines, drugs, vitamins, minerals, natural supplements and alternative medicines.
Side Effects
The following side effects are discussed in the full Patient Medication Information for KLOXXADO®:
- Body aches, stomach cramps
- Diarrhea
- Rapid heartbeat
- Fever
- Runny nose, sneezing
- Goosebumps, shivering or trembling
- Sweating
- Yawning
- Nausea or vomiting
- Nervousness
- Restlessness or irritability
- High blood pressure
Infants may have seizures, cry more than normal and have overactive reflexes.
Some people may become aggressive after abrupt reversal of opioid overdose.
In two clinical studies, a total of 47 healthy adult volunteers were exposed to a single dose of KLOXXADO®, one spray in one nostril. Side effects were reported in two subjects for each of the following: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope.
These are not all of the possible side effects of KLOXXADO®. Contact your doctor for medical advice about side effects.
Pregnancy, Infancy and Breastfeeding, Children
Tell your doctor if you are pregnant or think you are pregnant. Use of KLOXXADO® may cause distress to you and your unborn baby. A healthcare provider should monitor you and your unborn baby right away after you use KLOXXADO®.
Tell your doctor if you are breast-feeding or plan to breastfeed. It is not known if KLOXXADO® passes into breast milk.
If the primary concern is an infant at risk of an overdose, consider whether other naloxone-containing products may be more appropriate.
Dosage and Administration
Do not attempt to prime or test-fire the device. Each KLOXXADO® Nasal Spray contains only 1 dose of medicine and cannot be reused. Read the "instructions for use" at the end of the Patient Medication Information and Medication Guide for detailed information about the right way to use KLOXXADO® Nasal Spray.
Storage and Handling
Store KLOXXADO® at room temperature between 59°F to 86°F (15°C to 30°C). Do not freeze KLOXXADO®. KLOXXADO® freezes at temperatures below -15°C. If this happens, KLOXXADO® may be thawed by allowing it to sit at room temperature for 15 minutes. It may still be used if it has been thawed after being frozen.
Keep KLOXXADO® in its box until ready to use. Protect from light. Replace KLOXXADO® before the expiration date on the box. Keep KLOXXADO® and all medicines out of the reach and sight of children.
For more information, please see the full Prescribing Information and Medication Guide, which you can find on our website at www.kloxxado.com.
- To report an adverse event or product complaint, please contact us at us.hikma@primevigilance.com or call 1-877-845-0689 or 1-800-962-8364.
- Adverse events may also be reported to the FDA directly at 1-800-FDA-1088 or www.fda.gov/medwatch.
About NARCAN® Nasal Spray
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.
Always read the label and follow the directions for use.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including statements regarding Emergent’s ability to market and sell KLOXXADO® Nasal Spray in Canada pursuant to the terms of the six-year commercial agreement with Hikma, are forward-looking statements. We generally identify forward-looking statements by using words like “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “future,” “goal,” “intend,” “may,” “plan,” “position,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” and similar expressions or variations thereof, or the negative thereof, but these terms are not the exclusive means of identifying such statements. Forward-looking statements are based on our current intentions, beliefs and expectations regarding future events based on information that is currently available. We cannot guarantee that any forward-looking statements will be accurate. Readers should realize that if underlying assumptions prove inaccurate or if known or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Readers are, therefore, cautioned not to place undue reliance on any forward-looking statements. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake any obligation to update any forward-looking statement to reflect new information, events or circumstances.
There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by any forward-looking statements. Readers should consider this cautionary statement, as well as the risk factors and other disclosures included in our periodic reports filed with the U.S. Securities and Exchange Commission, when evaluating our forward-looking statements.
1 https://health-infobase.canada.ca/substance-related-harms/opioids-stimulants/
2 https://www.canada.ca/en/health-canada/news/2025/03/statement-from-the-minister-of-mental-health-and-addictions-and-associate-minister-of-health-on-the-toxic-illegal-drug-supply-and-overdose-crisis.html
FAQ
When will KLOXXADO 8mg nasal spray be available in Canada?
How does KLOXXADO differ from NARCAN nasal spray in Canada?
What is the current opioid overdose death rate in Canada?
Who will distribute KLOXXADO in Canada?
What is the trend in Canadian overdose deaths according to Health Canada?
