KLOXXADO® 8mg Naloxone Nasal Spray Shelf-Life Now 36 Months

Hikma Pharmaceuticals PLC (Hikma), a global pharmaceutical company, has announced an extension of the shelf life for KLOXXADO® (naloxone HCl) nasal spray 8mg from 24 months to 36 months. This update is reflected in the packaging of products manufactured from March 2024 onwards.

KLOXXADO® contains double the amount of naloxone per spray compared to Narcan® Nasal Spray 4mg, making it a crucial treatment option in combating opioid overdoses. Naloxone, the active ingredient, is widely acknowledged as a safe and effective antidote for opioid overdose. With the rise of synthetic opioids like fentanyl, health organizations including the CDC and the American Medical Association have indicated that higher doses of naloxone may be needed to revive individuals experiencing opioid poisoning. KLOXXADO® addresses this need by offering a higher dose of naloxone in a ready-to-use nasal spray form.

Dr. Hafrun Fridriksdottir, President of Hikma Generics, emphasized the importance of this shelf-life extension. "This is great news for frontline responders and individuals who carry KLOXXADO®, as it ensures they have a reliable tool to reverse an overdose at any moment," she said. She also highlighted the role KLOXXADO® plays in fighting the opioid epidemic, particularly with the upcoming International Overdose Awareness Day on August 31st, noting the significant impact of supplying life-saving medication.

Naloxone hydrochloride works by quickly reversing the effects of an opioid overdose, restoring normal respiration in individuals experiencing severe overdose symptoms. It is intended for emergency use in both adults and children, but it is not a replacement for immediate medical care. KLOXXADO® is designed for rapid administration in environments where opioids are present, and it has received marketing approval from the US FDA. However, this approval is limited to the United States.

Hikma Pharmaceuticals has been committed to enhancing healthcare accessibility for over 45 years, producing high-quality medicines and distributing them globally. With its headquarters in the UK, Hikma operates across North America, the Middle East, North Africa, and Europe. The company is known for its broad range of branded and generic medications, striving to transform scientific advancements into practical healthcare solutions.

KLOXXADO® is a registered trademark of Hikma Pharmaceuticals USA Inc., while Narcan® is a registered trademark of Emergent Operations Ireland Limited.

Important safety information for KLOXXADO® includes:

- Do not use if allergic to naloxone hydrochloride or any other ingredients.
- KLOXXADO® should be used immediately if an opioid overdose is suspected, even without certainty, as delays can result in severe injury or death.
- Signs of an opioid overdose include unusual sleepiness, breathing difficulties, and pinpoint pupils.
- Family members and caregivers should be familiar with the storage and administration of KLOXXADO®.
- Emergency medical help should be sought immediately after the first dose, as symptoms may recur, necessitating further doses.
- KLOXXADO® can induce sudden and severe opioid withdrawal, with symptoms such as body aches, increased heart rate, and nausea. In infants, withdrawal can be life-threatening and may manifest as seizures or excessive crying.

Users should inform their healthcare providers of their medical conditions and any medications or supplements they are taking. Side effects reported in clinical studies include abdominal pain, dizziness, and nasal discomfort, among others. For pregnant or breastfeeding women, the effects of naloxone on infants or milk production are not fully known.

KLOXXADO® nasal spray should be stored at room temperature and protected from light, with replacement required before the expiration date. It is crucial to keep the product out of reach of children.