KLOXXADO® 8mg Naloxone Nasal Spray Shelf-Life Extended from 24 months to 36 months
Hikma Pharmaceuticals PLC announces the shelf-life extension of KLOXXADO® (naloxone HCl) nasal spray 8mg from 24 to 36 months. This change applies to products manufactured from March 2024 onwards. KLOXXADO® contains twice the naloxone dose of Narcan® Nasal Spray 4mg, offering a important treatment option for opioid overdose reversal.
The extended shelf-life is particularly beneficial for frontline responders and individuals carrying KLOXXADO® for emergency use. This development comes as organizations like the CDC and American Medical Association note that higher doses of naloxone may be necessary to counteract poisoning from illicit fentanyl and other synthetic opioids. Hikma emphasizes its role in combating the opioid crisis, especially as International Overdose Awareness Day approaches on August 31st.
Hikma Pharmaceuticals PLC annuncia la prolungamento della durata di conservazione di KLOXXADO® (naloxone HCl) spray nasale 8mg da 24 a 36 mesi. Questa modifica si applica ai prodotti fabbricati a partire da marzo 2024. KLOXXADO® contiene il doppio della dose di naloxone rispetto a Narcan® Nasal Spray 4mg, offrendo un'importante opzione terapeutica per il trattamento dell'overdose da oppiacei.
Il prolungamento della durata di conservazione è particolarmente vantaggioso per i soccorritori in prima linea e per le persone che portano KLOXXADO® per uso emergenziale. Questo sviluppo arriva mentre organizzazioni come il CDC e l'American Medical Association notano che dosi più elevate di naloxone potrebbero essere necessarie per contrastare il veleno da fentanyl illecito e altri oppiacei sintetici. Hikma enfatizza il proprio ruolo nella lotta alla crisi degli oppiacei, soprattutto in vista della Giornata Internazionale di Sensibilizzazione sull'Overdose, che si avvicina il 31 agosto.
Hikma Pharmaceuticals PLC anuncia la prórroga de la vida útil de KLOXXADO® (naloxona HCl) aerosol nasal 8mg de 24 a 36 meses. Este cambio se aplica a los productos fabricados a partir de marzo de 2024. KLOXXADO® contiene el doble de la dosis de naloxona que Narcan® Nasal Spray 4mg, ofreciendo una opción de tratamiento importante para la reversión de la sobredosis por opiáceos.
La extensión de la vida útil es especialmente beneficiosa para los respondedores de primera línea y las personas que llevan KLOXXADO® para uso de emergencia. Este desarrollo se produce mientras organizaciones como los CDC y la Asociación Médica Americana señalan que dosis más altas de naloxona pueden ser necesarias para contrarrestar la intoxicación por fentanilo ilícito y otros opiáceos sintéticos. Hikma enfatiza su papel en la lucha contra la crisis de los opiáceos, especialmente con la llegada del Día Internacional de Concienciación sobre la Sobredosis el 31 de agosto.
Hikma Pharmaceuticals PLC가 KLOXXADO® (날록손 HCl) 비강 스프레이 8mg의 유통기한을 24개월에서 36개월로 연장한다고 발표했습니다. 이 변경 사항은 2024년 3월부터 제조된 제품에 적용됩니다. KLOXXADO®는 Narcan® Nasal Spray 4mg의 날록손 용량의 두 배를 포함하여 오피오이드 과다 복용에 대한 중요한 치료 옵션을 제공합니다.
연장된 유통기한은 특히 응급 사용을 위해 KLOXXADO®를 소지한 1차 대응자와 개인에게 유익합니다. CDC와 미국의료협회와 같은 기관이 불법 펜타닐 및 다른 합성 오피오이드로 인한 중독을 극복하기 위해 더 높은 용량의 날록손이 필요할 수 있다고 지적하면서 이 개발이 이루어졌습니다. Hikma는 8월 31일 국제 과다 복용 인식의 날이 다가오면서 오피오이드 위기 해결에 있어 그 역할을 강조합니다.
Hikma Pharmaceuticals PLC annonce la prolongation de la durée de conservation de KLOXXADO® (naloxone HCl) spray nasal 8mg de 24 à 36 mois. Ce changement s'applique aux produits fabriqués à partir de mars 2024. KLOXXADO® contient le double de la dose de naloxone de Narcan® Nasal Spray 4mg, offrant une option de traitement importante pour l'inversion d'une overdose d'opioïdes.
La durée de conservation prolongée est particulièrement bénéfique pour les secouristes en première ligne et les personnes portant KLOXXADO® à des fins d'urgence. Ce développement intervient alors que des organisations telles que le CDC et l'American Medical Association notent que des doses plus élevées de naloxone peuvent être nécessaires pour contrer l'intoxication par le fentanyl illicite et d'autres opioïdes synthétiques. Hikma met en avant son rôle dans la lutte contre la crise des opioïdes, surtout à l'approche de la Journée internationale de sensibilisation aux overdoses, le 31 août.
Hikma Pharmaceuticals PLC kündigt die Verlängerung der Haltbarkeit von KLOXXADO® (Naloxon HCl) Nasenspray 8mg von 24 auf 36 Monate an. Diese Änderung gilt für Produkte, die ab März 2024 hergestellt werden. KLOXXADO® enthält doppelt so viel Naloxon wie Narcan® Nasenspray 4mg und bietet eine wichtige Behandlungsoption zur Umkehrung einer Opioidüberdosierung.
Die verlängerte Haltbarkeit ist insbesondere für Ersthelfer und Personen von Vorteil, die KLOXXADO® für den Notfall mitführen. Diese Entwicklung erfolgt, während Organisationen wie die CDC und die American Medical Association darauf hinweisen, dass höhere Dosen von Naloxon erforderlich sein könnten, um Vergiftungen durch illegalen Fentanyl und andere synthetische Opioide entgegenzuwirken. Hikma hebt seine Rolle im Kampf gegen die Opioidkrise hervor, insbesondere im Hinblick auf den Internationalen Tag der Sensibilisierung für Überdosierungen am 31. August.
- Shelf-life of KLOXXADO® extended from 24 to 36 months, improving product longevity
- KLOXXADO® contains twice the naloxone dose of Narcan® Nasal Spray 4mg, potentially more effective against synthetic opioid overdoses
- Extended shelf-life may increase product appeal and market competitiveness
- None.
Insights
The shelf-life extension of KLOXXADO® from 24 to 36 months is a significant development in the fight against opioid overdoses. This change enhances the product's market competitiveness and operational efficiency for Hikma Pharmaceuticals. The longer shelf-life could lead to:
- Reduced waste and improved inventory management for healthcare providers and first responders
- Potential cost savings in production and distribution
- Increased accessibility of the product, particularly in areas with less frequent turnover
From an investor perspective, this could translate to improved sales and market share for Hikma in the naloxone market. The timing, coinciding with International Overdose Awareness Day, may also boost the company's public image and corporate social responsibility profile.
The extension of KLOXXADO®'s shelf-life is a crucial advancement in overdose prevention strategies. With the rising prevalence of synthetic opioids like fentanyl, higher-dose naloxone products are increasingly vital. The 36-month shelf-life addresses several key public health concerns:
- Improved accessibility and readiness for emergency use
- Enhanced cost-effectiveness for public health programs and harm reduction initiatives
- Potential for wider distribution and stockpiling in high-risk areas
This development aligns with recommendations from leading health organizations and could significantly impact overdose mortality rates. For Hikma, this positions them as a key player in addressing a critical public health issue, potentially leading to increased adoption of their product by healthcare systems and government agencies.
KLOXXADO® contains twice as much naloxone per spray as Narcan® Nasal Spray 4mg in a ready-to-use nasal spray to reverse the effects of opioid overdose, providing an important treatment option in addressing the overdose epidemic.1,2
Naloxone has long been recognized as an important, safe and effective treatment in the fight against opioid overdose.3 With the increasing prevalence of illicitly manufactured synthetic opioids, organizations including the CDC,4 the American Medical Association5 and others have noted that a higher dose of naloxone may be required to revive a patient experiencing poisoning from illicit fentanyl or other opioids. As a ready-to-use nasal spray that contains twice as much naloxone per spray than Narcan® Nasal Spray 4mg, KLOXXADO® provides an important lifesaving treatment option.1,2
"The shelf-life extension is good news for frontline responders and the thousands of people who carry KLOXXADO® and who may need to use it at a moment's notice to reverse an overdose," said Dr. Hafrun Fridriksdottir, President, Hikma Generics. "We have a role to play in the fight against illicit fentanyl and as we approach International Overdose Awareness Day on August 31st, it's gratifying that we are supplying an important medicine that can save lives and help address the deadly overdose epidemic."
About Naloxone
Naloxone hydrochloride is a medicine that rapidly reverses an opioid overdose. It can quickly restore normal breathing in someone experiencing an opioid overdose and should be given to any person who shows signs of an opioid overdose or when an opioid overdose is suspected.6
KLOXXADO® is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients.1 KLOXXADO® is not a substitute for emergency medical care.1 KLOXXADO® is intended for immediate administration as emergency therapy in settings where opioids may be present.1
This product has been approved for marketing in
Enquiries
Hikma Pharmaceuticals USA
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About Hikma
Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ
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
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
Warnings and Precautions
- 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 emergency may include:
- Unusual sleepiness; you are not able to awaken the person with a loud voice or by rubbing firmly on the middle of their chest (sternum).
- Breathing problems, including slow or shallow breathing in someone difficult to awaken or who looks like they are not breathing.
- The black circle in the center of the colored part of the eye (pupil) is very small (sometimes called "pinpoint pupils") in someone difficult to awaken.
- 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.
- Get emergency medical help right away after using the first dose of 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, alternating nostrils, 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, increased heart rate, fever, runny nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, stomach cramps, weakness and increased blood pressure.
- In infants under 4 weeks old who have been receiving opioids regularly, sudden opioid withdrawal may be life-threatening if not treated the right way. Signs and symptoms include: seizures, crying more than usual, and increased reflexes.
- Tell your doctor about all of your medical conditions before using KLOXXADO®, including if you have heart problems, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed.
- Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, drugs, vitamins and herbal supplements.
Side Effects
The following serious side effect is discussed in the full Prescribing Information for KLOXXADO®:
- Sudden and Severe Opioid Withdrawal
Symptoms of sudden and severe opioid withdrawal resulting from the use of KLOXXADO® in someone regularly using opioids include: body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, stomach cramps, weakness and increased blood pressure.
Infants may have seizures, cry more than normal and have increased 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 plan to become pregnant. If you are pregnant and opioid dependent, use of KLOXXADO® may cause withdrawal symptoms in you and your unborn baby. A healthcare provider should monitor you and your unborn baby right away after you use KLOXXADO®.
There is no information regarding the presence of naloxone in human milk, the effects of naloxone on the breastfed infant or on milk production.
If the primary concern is an infant at risk of an overdose, consider whether other naloxone-containing products may be more appropriate.
KLOXXADO® nasal spray is safe and effective in children for known or suspected opioid overdose.
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 Prescribing 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 68°F to 77°F (20°C to 25°C). Do not expose to temperatures below 41°F (5°C) or above 104°F (40°C). Do not freeze KLOXXADO®. 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 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.
Distributed by: Hikma Specialty USA Inc., Columbus, OH 43228.
Document Identification Number: HK-2667-v1
1 https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ebf0f833-c1c0-487c-8f29-01fa8c61b6cb&type=display
2 https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=a0ebc83d-2892-40de-bc0a-775ce90b30db&type=display
3 https://pubmed.ncbi.nlm.nih.gov/28722939/
4 https://archive.cdc.gov/#/details?url=https://emergency.cdc.gov/han/2020/han00438.asp
5 https://apnews.com/article/opioids-business-health-government-and-politics-8263d4b147b3c6b104346b4ca31c28a3
6 https://nida.nih.gov/publications/drugfacts/naloxone
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SOURCE Hikma Pharmaceuticals USA Inc.
FAQ
What is the new shelf-life of Hikma's KLOXXADO® (HKMPY) nasal spray?
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