TAKING ON THE OPIOID OVERDOSE EPIDEMIC IN NEW JERSEY

Three Healthcare Organizations Join Forces to Save Lives

HACKENSACK, N.J., Aug. 3, 2023 /PRNewswire/ -- HIKMA Pharmaceuticals, Hackensack Meridian Health (HMH) and non-profit Dispensary of Hope are teaming up to pilot a Take-Home Naloxone Program to stem the tide of opioid overdose fatalities by delivering Kloxxado® (naloxone HCl) Nasal Spray 8 mg free of charge to patients at high risk of an opioid overdose. Kloxxado® contains naloxone, an opioid antagonist that can save the lives of patients who have overdosed with an opioid.¹ All three organizations share a vision of providing affordable medication access, with a particular focus on communities and individuals who are most vulnerable.

Opioid overdoses are preventable and tragic. According to a report published in the Lancet, more than 1.2 million Americans will die in this decade from Opioid Overdose.² The current wave of overdose deaths is being driven by illicitly manufactured synthetic opioids like fentanyl, which are 50x more potent than heroin and may require more naloxone to reverse. ^3,4,5 In fact, 78% of all overdose reversals involve at least 8 mg of naloxone, according to a study published in 2022.⁶

With a drug overdose mortality rate of 32.4 per hundred thousand people, resulting in more than 3,000 deaths per year, New Jersey continues to battle the opioid epidemic as does the rest of the country.⁷

"As a leading New Jersey based pharmaceutical company with a mission of improving health and saving lives, we were compelled to act," said Christopher Bonny, VP of Marketing and Brand Rx Operations at Hikma Pharmaceuticals. "Since launching Kloxxado® less than two years ago, we've seen numerous instances of lives saved at schools, concerts, hotels, parks and many other locations and situations. We are pleased to support the life-saving work of Hackensack Meridian Health and Dispensary of Hope by donating this important medication to help reverse opioid overdoses and serve the urgent needs of those at risk."

"Even though naloxone medications like Kloxxado® can reverse the effects of an opioid overdose, not enough patients at risk have access to naloxone," said Hillary Blackburn, Chief Pharmacy Officer, at Dispensary of Hope.⁸ "With 40% of overdoses happening in front of another person⁹, we know we can save lives by engaging in creative strategies to deliver pragmatic results."

The pilot project began in May 2023 with the aim of dispensing 2,500 doses of Kloxxado®. During the pilot program, HIKMA Pharmaceuticals, the manufacturer of Kloxxado®, will deliver it to Dispensary of Hope. Dispensary of Hope–a nonprofit medication distributor–will then distribute the medications to pre-approved sites of need at HMH. HMH will then dispense the medication to patients, as well as friends and family members of the patients who are at risk.

According to Aakash Shah, M.D., Chief of Addiction Medicine at Jersey Shore University Medical Center, "With deadly substances like fentanyl in the drug supply, it has never been more important to ensure that patients have access to life-saving medications like Kloxxado®. This partnership is a quintessential example of how organizations can and should come together to do exactly that."

¹ KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
² Humphreys et. Al. 2022, "Responding to the opioid crisis in North America and beyond: recommendations of the Stanford–Lancet Commission," The Lancet,  399:10324, p555-604
³ Opioid Basics: Understanding the Opioid Epidemic. CDC, Retrieved from https://www.cdc.gov/opioids/basics/epidemic.html on 2022 1206; Fentanyl Facts. CDC, Retrieved from https://www.cdc.gov/stopoverdose/fentanyl/index.html on 2022 1206
⁴ Stop Overdose - Fentanyl. CDC, https://www.cdc.gov/stopoverdose/fentanyl/index.html, Accessed 2022 1006
⁵ Naloxone. National Institutes of Health. Accessed March 26, 2021. https://www.drugabuse.gov/publications/drugfacts/naloxone.
⁶ Abdelal et al., 2022, "Real-world study of multiple naloxone administration for opioid overdose reversal among bystanders," Harm Reduction Journal, 19:49.
⁷ Drug Overdose Mortality by State. CDC, https://www.cdc.gov/nchs/pressroom/sosmap/drug_poisoning_mortality/drug_poisoning.htm, Accessed 2023 0604
⁸ Guy GP Jr, et al. 2021 Concurrent Naloxone Dispensing Among Individuals with High-Risk Opioid Prescriptions, USA, 2015–2019. J Gen InternMed 36(10):3254–6.
⁹ Lifesaving Naloxone. CDC, https://www.cdc.gov/stopoverdose/naloxone/, Accessed 2023 0604
¹⁰Naloxone Hydrochloride Injection, USP [prescribing information]. Eatontown, NJ: Hikma Pharmaceuticals USA Inc., 2019

Kloxxado® Is a registered trademark of Hikma Pharmaceuticals USA Inc.

About Hikma
Hikma helps put better health within reach every day for millions of people around the world. For more than 40 years, Hikma has been creating high-quality medicines and making them accessible to the people who need them.

Among Hikma's life saving medicines, Hikma is a leading manufacturer of naloxone and addiction therapies.  Naloxone rapidly reverses an opioid overdose and can be given as a nasal spray or injected.^1,10 We manufacture both a nasal spray, KLOXXADO^®, and an injectable naloxone medicine. With the ongoing opioid epidemic affecting hundreds of thousands of people each year, naloxone is an important medicine that should be readily available to those who need it.

About Hackensack Meridian Health 
Hackensack Meridian Health is a leading not-for-profit healthcare organization that is the largest, most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care. The network has 18 hospitals and more than 500 patient care locations, which include ambulatory care centers, surgery centers, home health services, long-term care and assisted living communities, ambulance services, lifesaving air medical transportation, rehabilitation centers, urgent care centers, physician practice locations, and a fitness and wellness center. With more than 35,000 team members and 7,000 physicians, Hackensack Meridian Health is a distinguished leader in health care philanthropy and committed to the health and well-being of communities throughout New Jersey.

The network's notable distinctions include having more U.S. News-ranked hospitals than any other health system in New Jersey, as ranked by U.S. News & World Report, 2022-23. Hackensack University Medical Center is nationally-ranked by U.S. News & World Report in four specialties, more than any other hospital in New Jersey. Joseph M. Sanzari Children's Hospital at Hackensack University Medical Center, and K. Hovnanian Children's Hospital at Jersey Shore University Medical Center, are ranked #1 in the state and top 20 in the Mid-Atlantic Region by U.S. News & World Report's 2022-23 Best Children's Hospital  Report. Additionally, their combined nephrology program ranks in the top 50 in the United States. To learn more, visit www.hackensackmeridianhealth.org.  

About Dispensary of Hope
Nashville-based nonprofit, Dispensary of Hope, has been actively operating and building a national model of medication access for the most vulnerable for over a decade. This innovative model unifies pharmaceutical manufacturing and safety net healthcare delivery with a common goal of saving and transforming lives. The model is unique in its ability to converge different areas of the healthcare industry to provide access to medication at no cost to the patient, while maintaining the highest quality standards in the medication distribution industry. The collaboration delivers pragmatic results which include improved health outcomes for patients, reduced cost and environmental impact from medication destruction and positive shifts in healthcare cost burden from acute care treatment to health condition management.

Kloxxado^® (naloxone HCl) Nasal Spray 8 mg Indication¹

KLOXXADO^® is an opioid antagonist 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. KLOXXADO^® is intended for immediate administration as emergency therapy in settings where opioids may be present. KLOXXADO^® is not a substitute for emergency medical care.

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, opioid withdrawal may be life-threatening if not recognized and properly treated. Infants going through opioid withdrawal may have seizures, cry more than normal, and have 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.
• 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. 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088.

Distributed by: Hikma Specialty USA Inc., Columbus, OH 43228.

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SOURCE Dispensary of Hope