The Opioid Epidemic

The Opioid Epidemic2024-03-04T12:09:20-05:00

1.2 million opioid overdose deaths is 1.2 million too many1-4

The opioid epidemic has become one of the most devastating public health emergencies of our time.1,2,3,4 According to a February 2023 report from the Stanford-Lancet Commission on the North American Opioid Crisis, 1.2 million people in the US and Canada are expected to die of opioid overdose by the end of the decade.1 Powerful illicit drugs have infiltrated our cities, towns, neighborhoods and schools, and could claim the lives of the people we love.2,5 That’s why we should learn everything we can about the opioid epidemic and the interventions that can help keep ourselves, our families and our communities safe.

Be prepared. Take action. Save lives.

Ask your doctor about Kloxxado® (naloxone HCl) nasal spray 8 mg and how you can use it to help reverse deadly opioid overdose.6

About the opioid epidemic

According to the Centers for Disease Control, the opioid epidemic is a decades-old problem.2 However, the most recent wave of deaths–largely driven by illicitly manufactured fentanyl and other synthetic opioids–has been by far the most significant.2

The stress, isolation and other hardships experienced by so many during the COVID-19 pandemic may have exacerbated what was already an unprecedented public health crisis.7 According to the National Center for Health Statistics, annual overdose deaths surged by 50% during the COVID-19 pandemic.33

According to the Centers for Disease Control, more than 100,000 people died of a drug overdose in 2021 alone.1,3 This spike in overdose deaths can be partly attributed to the flood of illicitly manufactured fentanyl coming into the illegal drug supply.8 In 2022, the US Drug Enforcement Administration (DEA) seized enough fentanyl to kill every person in the US.8 The tiniest dose of the drug—just 2 milligrams—can be lethal, and it can be found in every corner of our society.5,8,9

“[Illicit] fentanyl is the single deadliest drug threat our nation has ever encountered. Fentanyl is everywhere. From large metropolitan areas to rural America, no community is safe from this poison. We must take every opportunity to spread the word to prevent fentanyl-related overdose death and poisonings from claiming scores of American lives every day.”9

Anne Milgram
FDA Administrator

Types of illicit opioids

Reducing opioid overdose deaths with naloxone

As the opioid epidemic has progressed, the illicit drugs have become more potent and pervasive.8

Most people who use illegal drugs do not think they will die of an overdose, but accidents happen. Accidental overdoses do not have to be fatal, however.14,15 Nearly 40 percent of overdose deaths involving opioids happen with someone nearby.14 If a bystander is armed with naloxone, the outcome could be different.15

If you or someone you know is at risk for opioid overdose, you should keep naloxone with you at all times.14 Life-saving naloxone medications like Kloxxado® are small to carry and easy to use.6,14 Naloxone can quickly reverse an overdose by blocking the effects of the opioid and restoring breathing—usually within 2 to 3 minutes.14 It won’t harm someone if they are overdosing on a non-opioid, so it’s always best to use naloxone if you suspect that a person is experiencing an overdose.14 If you give someone naloxone for suspected opioid overdose, be sure to stay with them until emergency help arrives or for at least 4 hours to ensure that their breathing returns to normal.14

The history of naloxone and harm reduction

Naloxone is considered one of the World Health Organization’s essential medicines.16 Here’s a brief history of this life-saving molecule from concept to Kloxxado®:

Preloader
  • Naloxone Invented

    Naloxone Invented

    Jack Fishman, an immigrant from Poland, invented naloxone in 1961 while trying to come up with a way to treat constipation caused by chronic opioid use.17,18

  • Naloxone Receives U.S. Patent

    Naloxone Receives U.S. Patent

    Synthesis of naloxone was patented in the United States.19

  • Naloxone Receives FDA Approval

    Naloxone Receives FDA Approval

    FDA approved naloxone for treating opioid overdoses by intravenous administration or injection in a healthcare setting.20

  • Experiments with Nasal Naloxone

    Experiments with Nasal Naloxone

    Initial experiments with “community” naloxone: prefilled syringes with atomizers for nasal administration (not FDA-approved) were conducted.21

  • First FDA-Approved Community-Use Naloxone

    First FDA-Approved Community-Use Naloxone

    Evzio® Auto-Injector gained fast-tracked FDA approval as first naloxone medication designed for community use.22

  • First Intranasal Naloxone

    First Intranasal Naloxone

    Narcan® (naloxone HCl) Nasal Spray 4 mg, the first intranasal naloxone, gained fast-tracked FDA approval amid high rates of heroin overdoses.23

  • Kloxxado® Introduced to Market

    Kloxxado® Introduced to Market

    Kloxxado® (naloxone HCl) nasal spray 8 mg, the first higher-dose intranasal naloxone, gained FDA approval with illicit fentanyl driving the opioid epidemic.24

Understanding opioid overdose

Since 1999, drug overdoses have claimed the lives of more than a million people.3,25 Drug overdose is now the leading cause of unintentional death in the US, and most of these involve opioids.26 The influx of illicit fentanyl into the nation’s illegal drug supply may be largely to blame.8

Although death is the worst consequence of opioid overdose, it is important to keep in mind that even a non-fatal overdose is damaging if not reversed quickly enough. Brain injury can occur as a result of slowed heart rate and breathing.27-29

The risks and dangers of brain injury

Depending on which parts of the brain are damaged and how long the brain was deprived of oxygen, an opioid overdose survivor may suffer with:27,28
  • Limb weakness
  • Balance and coordination issues
  • Spasticity or rigidity in muscle tone
  • Abnormal, involuntary movements
  • Loss of vision
  • Memory loss
  • Speech and language challenges
  • Changes in cognitive abilities related to thinking and decision making that can impact future planning, work and social interactions
  • Changes in personality, including irritability, impulsiveness and social impairments

Brain injury can present new challenges that can be difficult to manage, especially if the overdose survivor is also trying to cope with substance use.27 It can take a long time to determine the extent of the damage and establish a continuing care plan to help the person recover.27 In addition to the physical effects, brain injury can have a significant impact on a person’s mental health and well-being.27

Kloxxado® and opioid overdose reversal

As illicit opioids become stronger and more widely available, overdose reversals often involve 8 mg or more of naloxone.14,30,31 And when a single dose of naloxone does bring a person back, there is always the risk that the opioid will outlast the medicine and the person will again become unconscious.11,31

Kloxxado® (naloxone HCl) nasal spray 8 mg contains twice as much naloxone as Narcan® (naloxone HCl) Nasal Spray 4 mg.6,11 As increasingly potent illegal opioids continue to infiltrate our communities, Kloxxado® can empower citizens to make a life-or-death difference in an opioid overdose emergency.6

How does Kloxxado® work?

Naloxone, the active ingredient in Kloxxado® nasal spray, is a medicine called an opioid antagonist.6 It works by attaching to the opioid receptors in the brain and reversing or blocking the action of the opioid.6 By reversing or blocking the action of the opioid, Kloxxado® can quickly restore normal breathing in someone who is suffering with an opioid overdose.6 It is sprayed directly in the person’s nostril and does not require evidence of breathing through the nose during administration.6

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What is Naloxone?

This short video from the Substance Abuse and Mental Health Services Administration (SAMHSA) explains how naloxone works in the body.

What should you do in case of opioid overdose?

Anyone can administer Kloxxado® in just 4 steps:6

Once Kloxxado® has been given, call 911. Kloxxado® nasal spray is not a substitute for emergency medical care.6

Ideally, emergency medical services (EMS) will arrive before a second dose of Kloxxado® is needed. If the person has not responded after a few minutes and EMS still has not arrived, a second dose of Kloxxado® may be necessary. This might happen in the case of an overdose that involves strong opioids or if the naloxone wears off before the opioids do.31,6

You can administer additional doses of Kloxxado® every 2 or 3 minutes (in alternating nostrils) if the overdose person does not respond, responds insufficiently or loses consciousness.6

Kloxxado® Patient Brochure

Read about the key benefits of Kloxxado® nasal spray.

Opioid and overdose FAQs

What happens if you give Kloxxado® to someone who is not on opioids?2023-07-15T11:23:14-04:00

Naloxone, the medicine in Kloxxado®, works only if a person has opioids in their system.*† It has no effect if opioids are not present.† Administering naloxone is unlikely to harm someone, but it could save their life if they are experiencing an opioid overdose.†

* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
† Access to Naloxone Can Save a Life During an Opioid Overdose. US Food and Drug Administration website. Available at: https://www.fda.gov/consumers/consumer-updates/access-naloxone-can-save-life-during-opioid-overdose. Accessed March 5, 2023.

Someone I know may be misusing opioids. Where can I learn more?2023-07-15T11:21:38-04:00

If you or someone you love is at risk for misusing opioids, resources and help are available. Find information about substance use disorder treatment options on findtreatment.gov, a product of the Substance Abuse and Mental Health Services Administration.  Connect with harm reduction resources near you at harmreduction.org, the official website of the National Harm Reduction Coalition.

What are the possible side effects from using Kloxxado® nasal spray?2023-09-15T14:08:25-04:00

Across Kloxxado® nasal spray’s two pharmacokinetics (PK) studies, adverse reactions were reported in two subjects for each of the following: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope.*

Risks include: Risk of Recurrent Respiratory & CNS Depression; Risk of limited efficacy with partial agonists or mixed agonist/antagonists; Precipitation of severe opioid withdrawal; Risk of CV effects.*

For more information, please see the full Prescribing Information and Important Safety Information.

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.

* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021

How does Kloxxado® nasal spray work?2023-07-15T10:57:12-04:00

Kloxxado® nasal spray is administered in the nostril and does not require evidence of breathing through the nose during administration.*

Opioids work by attaching to specific receptors found in the brain and in the nervous system.† This includes the nerves that sense pain, as well as the nerves that control breathing.† Taking too many opioids can lead to an overdose and that can stop someone from breathing.†

Naloxone, the active ingredient in Kloxxado®, stops the opioids from attaching to the receptors on the nerves.* This reverses the effects and symptoms of the overdose.*‡

Get emergency medical help right away in any case of known or suspected overdose emergency. Kloxxado® nasal spray is not a substitute for emergency medical care.* Administer in accordance with the instructions provided in the Kloxxado® Quick Instructions for Use.

Each device is a single dose.* If an additional dose is needed, you must use another device.*

* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021.
† White JM & Irvine RJ. 1999, “New Horizons/Mechanisms of fatal opioid overdose,” Addiction, 94(7):961–972.
‡ NIDA 2021. “Naloxone DrugFacts,” National Institute on Drug Abuse, https://www.drugabuse.gov/publications/drugfacts/naloxone, Accessed May 3, 2021.

What is Kloxxado® (naloxone HCl) nasal spray 8 mg?2023-07-15T10:36:33-04:00

Kloxxado® is a nasal spray that contains a single spray with 8 mg of naloxone HCl.* Kloxxado® can be used by anyone to reverse the effects of an opioid overdose until medical help arrives.* Each box of Kloxxado® contains two individually packaged single-spray devices.*

Always carry Kloxxado® with you in case of an opioid emergency.

* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021

References

  1. Humphreys K, et al. Responding to the opioid crisis in North America and beyond: recommendations of the Stanford-Lancet Commission. The Lancet Commissions. 2022;399(10324):555-604.
  2. Understanding the Opioid Overdose Epidemic. Centers for Disease Control and Prevention website. Available at: https://www.cdc.gov/opioids/basics/epidemic.html. Accessed March 5, 2023.
  3. Ahmad et al. Provisional Drug Overdose Death Counts. Centers for Disease Control and Prevention website. Available at: Products – Vital Statistics Rapid Release – Provisional Drug Overdose Data (cdc.gov). Accessed March 5, 2023.
  4. FACT SHEET: Biden-Harris Administration Announces New Action and Funding to Address the Opioid Epidemic and Support Recovery. The White House website. Available at: https://www.whitehouse.gov/briefing-room/statements-releases/2022/09/23/fact-sheet-biden-harris-administration-announces-new-actions-and-funding-to-address-the-overdose-epidemic-and-support-recovery/. Accessed March 21, 2023.
  5. Opioid Misuse in Rural America. US Department of Agriculture website. Available at: https://www.usda.gov/topics/opioids. Accessed March 5, 2023.
  6. Kloxxado® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021.
  7. How the COVID-19 pandemic created a “perfect storm” for opioid addiction. CBS News website. Available at: https://www.cbsnews.com/news/covid-19-pandemic-opioid-addiction/. Accessed March 5, 2023.
  8. Facts about Fentanyl. US Drug Enforcement Administration website. Available at: https://www.dea.gov/resources/facts-about-fentanyl. Accessed March 5, 2023.
  9. Fentanyl Awareness. US Drug Enforcement Administration website. Available at: https://www.dea.gov/fentanylawareness. Accessed March 5, 2023.
  10. Heroin DrugFacts. National Institutes of Health/National Institute on Drug Abuse website. Available at: https://nida.nih.gov/publications/drugfacts/heroin. Accessed March 5, 2023.
  11. Narcan® (naloxone HCl) Nasal Spray [prescribing information]. Plymouth Meeting, PA: Emergent Devices Inc., 2020.
  12. Fentanyl Facts. Centers for Disease Control and Prevention website. Available at: https://www.cdc.gov/stopoverdose/fentanyl/index.html. Accessed March 5, 2023.
  13. Five Quick Facts: Carfentanil. Just Think Twice website. Available at: https://www.justthinktwice.gov/article/five-quick-facts-carfentanil. Accessed March 5, 2023.
  14. Lifesaving Naloxone. Centers for Disease Control and Prevention website. Available at: https://www.cdc.gov/stopoverdose/naloxone/. Accessed March 5, 2023.
  15. Morbidity and Mortality Weekly Report (MMWR) Vital Signs: Characteristics of Drug Overdose Deaths Involving Opioids and Stimulants–24 States and the District of Columbia, January-June 2019. Centers for Disease Control and Prevention website. Available at: https://www.cdc.gov/mmwr/volumes/69/wr/mm6935a1.htm?s_cid=mm6935a1_w#F3_down. Accessed March 21, 2023.
  16. Model List of Essential Medicines. World Health Organization website. Available at: https://list.essentialmeds.org/. Accessed March 5, 2023.
  17. Who Invented Naloxone? HuffPost website. Available at: https://www.huffpost.com/entry/meet-jack-fishman-the-man_b_6329512. Accessed March 5, 2023.
  18. Garfield D. Essays Information Scientist. 1983;16:121-130.
  19. US Patent Office. 3,254,088 morphine derivative. Available at: https://patentimages.storage.googleapis.com/a6/72/d6/cabe2af652cdd7/US3254088.pdf. Accessed March 5, 2023.
  20. Lloyd J. The Clinical Use of Naloxone. Available at: https://fda.report/media/92994/Presentation–The-Clinical-Use-of-Naloxone.pdf. Accessed March 5, 2023.
  21. Dowling J, et al. Population Pharmacokinetics of Intravenous, Intramuscular, and Intranasal Naloxone in Human Volunteers. Ther Drug Monit. 2008;30(4):490-496.
  22. EVZIO® (Naloxone hydrochloride) Injection Drug Approval Package. US Food and Drug Administration website. Available at: Drug Approval Package: EVZIO (Naloxone hydrochloride) Injection NDA 205787 (fda.gov). Accessed March 5, 2023.
  23. FDA moves quickly to approve easy-to-use nasal spray to treat opioid overdose. US Department of Health and Human Services website. Available at: https://wayback.archive-it.org/7993/20180125101447/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm473505.htm. Accessed March 5, 2023.17.
  24. FDA Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid Overdose. US Food and Drug Administration website. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-higher-dosage-naloxone-nasal-spray-treat-opioid-overdose. Accessed March 5, 2023.
  25. Opioids/Data Overview/The Drug Overdose Epidemic: Behind the Numbers. Centers for Disease Control and Prevention website. Available at: https://www.cdc.gov/opioids/data/index.html. Accessed March 5, 2023.
  26. Addressing the Opioid Crisis. National Safety Council website. Available at: https://www.nsc.org/community-safety/safety-topics/opioids/prescription-drug-misuse. Accessed March 5, 2023.
  27. Opioid overdose. Brain Injury Canada website. Available at: https://braininjurycanada.ca/en/non-traumatic-brain-injury/opioid-overdose/. Accessed March 5, 2023.
  28. Winstanley EL, et al. Neurocognitive impairments and brain abnormalities resulting from opioid-related overdoses: A systematic review. Drug Alcohol Depend. 2021;226:108838.doi:10.1016/j.drugalcdep.2021.108838.
  29. Opioid Overdose. Substance Abuse and Mental Health Services Administration website. Available at: https://www.samhsa.gov/medications-substance-use-disorders/medications-counseling-related-conditions/opioid-overdose. Accessed March 5, 2023.
  30. Naloxone: The Opioid Reversal Drug that Saves Lives. US Department of Health and Human Services website. Available at: https://www.hhs.gov/system/files/naloxone-coprescribing-guidance.pdf. Accessed March 5, 2023.
  31. Abdelal R, Banerjee AR, et al. Real-world study of multiple naloxone administration for opioid overdose reversal among bystanders. Harm Reduct J. 2022;19(49). https://doi.org/10.1186/s12954-022-00627-3
  32. Non-Fatal Opioid Overdose and Associated Health Outcomes: Final Summary Report. ASPE website. Available at: https://aspe.hhs.gov/sites/default/files/migrated_legacy_files//190846/Nonfatal.pdf. Accessed June 25, 2023.
  33. In 2021, US drug overdose deaths hit highest level on record, CDC data shows. CNN website. Available at: https://www.cnn.com/2022/05/11/health/drug-overdose-deaths-record-high-2021/index.html. Accessed Sep. 14, 2023.
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Important Safety Information About KLOXXADO® (naloxone HCl) Nasal Spray 8 mg

Contraindications