News

More than 5000 Lives Reported Saved with Help of EVZIO® (naloxone HCl injection) Auto-injectors

Richmond, Va. (January 11, 2018) – Kaléo, a privately-held pharmaceutical company, today announced that EVZIO^® (naloxone HCl injection) Auto-injectors have been reported to help save more than 5000 lives.

EVZIO was the first naloxone product specifically designed, FDA approved and labeled for the emergency treatment of opioid overdose by individuals without medical training. It is the first and only intelligent take-home naloxone auto-injector system with voice and visual guidance.

The 5000^th life saved was reported by Aimee Dunkle, of the Solace Foundation in Orange County, CA. In total, more than 1500 lives have been reported saved in California alone.

“Due to the generosity of the Kaléo Cares Product Donation Program our small non-profit has been able to distribute hundreds of EVZIO auto-injectors to individuals most likely to witness an opioid overdose,” said Aimee Dunkle, Executive Director of the Solace Foundation. “This incredible program has helped us save almost 500 lives in the last 2 years!  One of those reversals was me saving the life of another mother’s son, which was a profound moment given that I lost my own son to an accidental overdose in 2012.  We are so grateful for this life-saving program.”

“The opioid epidemic is killing 91 people each day,” said Spencer Williamson, President and CEO of Kaléo. “By empowering more patients to have access to this potentially life-saving medicine, we believe that EVZIO will help reduce the burden of opioid overdose across the nation. Since October 2014, we have received reports that EVZIO Auto-injectors have helped save an average of 30 lives per week.”

Kaléo, an innovative pharmaceutical company headquartered in Richmond, Virginia, was founded by identical twin brothers with life-threatening conditions. From their initial concept of a compact auto-injector with innovative features, such as an automatic retractable needle, all the way to FDA approval, it took years of hard work and many millions of dollars invested in research and development. Kaléo is proud to have more than 100 domestic and international issued patents and FDA approvals for five products in the last five years. Kaléo’s products have all been internally developed with final assembly in the United States using an automated robotic assembly process with more than 100 quality checks on every device.

Non-profit organizations across the country are helping to lead the charge to help get take-home naloxone into the hands of the family members and caregivers of those at risk for an accidental opioid overdose. Out of respect for patients’ privacy, Kaléo does not require information from organizations about recipients of donated product; therefore, these voluntarily reported lives saved may only represent a fraction of the total number of lives saved with the help of EVZIO.

“As a mother who lost her only child to opiate overdose in 2011 I am so grateful for the lives saved with EVZIO naloxone auto-injector kits,” said Robin Elliot, Co-founder of Georgia Overdose Prevention. “Our organization is aware of hundreds of overdose reversals with the EVZIO kits we have distributed.  We know of two specific cases where one EVZIO naloxone kit helped save two lives. I always think it is important to remember it isn’t just the victims’ lives who are forever changed by the overdose reversals, but the mothers and fathers and other family members, as well. Where there is life, there is hope.” Georgia non-profit, “Georgia Overdose Prevention,” has reported several-hundred lives saved with the help of donated EVZIO.

The Cabell-Huntington, WV Health Department has reported more than 1000 lives saved with the help of donated naloxone.

“Thanks to the generous EVZIO donation from Kaléo, we have been able to demonstrate that a Community Naloxone Distribution Program significantly improves the life-saving capability of a community affected by opioid overdose,” said Dr. Michael Kilkenny, MD, MS, Physician Director of the Cabell-Huntington, WV Health Department. “This year, in the City of Huntington, citizens used naloxone to reverse about as many opioid overdoses as EMS did, essentially doubling the life-saving response to this life-threatening complication of substance use disorder.  That’s double the people with another chance at recovery from their disease.”

Kaléo has also donated thousands of EVZIO Auto-injectors to health departments and non-profits in the Chicago area. Those organizations have used the donated EVZIO to help save hundreds of lives.

“Our ability to address the opioid epidemic requires that we have partners who are engaged in the cause,” said Mark Pfister, Executive Director of the Lake County Health Department and Community Health Center. “Our training of local law enforcement has been critical to the continued distribution of this life-saving medication in Lake County. As a result, our residents struggling with opioid use have a greater chance of entering into recovery and breaking the cycle of addiction.”

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About Kaléo (kuh-LAY-oh)

Kaléo is a pharmaceutical company dedicated to building innovative solutions for serious and life-threatening medical conditions. Our mission is to provide innovative solutions that empower patients to confidently take control of their medical conditions. We believe patients and caregivers are the experts on how their medical condition impacts their lives, and are an integral part of our product development process. Each Kaléo product combines an established drug with an innovative delivery platform. Kaléo is a privately-held company headquartered in Richmond, Virginia. For more information, visit www.kaleo.com.

INDICATION

EVZIO is a prescription medicine used in adults and children for the treatment of an opioid emergency such as an overdose or a possible opioid overdose with signs of breathing problems and severe sleepiness or not being able to respond. EVZIO is to be given right away and does not take the place of emergency medical care. Get emergency medical help right away after the first dose of EVZIO, even if the person wakes up. EVZIO is safe and effective in children for known or suspected opioid overdose.

IMPORTANT SAFETY INFORMATION 

What is the most important information I should know about EVZIO?

EVZIO is used to temporarily reverse the effects of opioid medicines. The medicine in EVZIO has no effect in people who are not taking opioid medicines. Always carry EVZIO with you in case of an opioid emergency.

• Use EVZIO right away if you or your caregiver think signs or symptoms of an opioid emergency are present, even if you are not sure, because an opioid emergency can cause severe injury or death. Signs and symptoms of an opioid emergency may include:
• unusual sleepiness and you are not able to awaken the person with a loud voice or rubbing firmly on the middle of their chest (sternum)
• breathing problems including slow or shallow breathing in someone difficult to awaken or they look 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 EVZIO in an opioid emergency should know where EVZIO is stored and how to give EVZIO before an opioid emergency happens.
• Get emergency medical help right away after using the first dose of EVZIO. Rescue breathing or CPR (cardiopulmonary resuscitation) may be given while waiting for emergency medical help.
• The signs and symptoms of an opioid emergency can return within several minutes after EVZIO is given. If this happens, give additional injections using new EVZIO auto-injectors every 2 to 3 minutes and continue to closely watch the person until emergency help is received.

Who should not use EVZIO?

Do not use EVZIO if you are allergic to naloxone hydrochloride or any of the ingredients in EVZIO.

What are the ingredients in EVZIO?

Active ingredient: naloxone hydrochloride

Inactive ingredients: sodium chloride, hydrochloric acid to adjust pH, and water

What should I tell my healthcare provider before using EVZIO?

Tell your healthcare provider about all of your medical conditions, including if you:

• have heart problems
• are pregnant or plan to become pregnant. Use of EVZIO may cause withdrawal symptoms in your unborn baby. Your unborn baby should be examined by a healthcare provider right away after you are given EVZIO.

Tell your healthcare provider about the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of EVZIO?

EVZIO may cause serious side effects, including:

• Sudden opioid withdrawal symptoms. In someone who has been using opioids regularly, opioid withdrawal symptoms can happen suddenly after receiving EVZIO and may include: body aches, fever, sweating, runny nose, sneezing, goose bumps, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, stomach cramping, increased blood pressure, and increased heart rate.

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.

Common side effects of EVZIO include dizziness and injection site redness.

These are not all of the possible side effects of EVZIO. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please click here to see the full Prescribing Information and the Patient Information, or visit www.evzio.com.