Welcome!

News Feed Item

More than 100 Lives Reported Saved Since Launch of the "kaleo Cares" EVZIO® (naloxone HCl injection) Donation Program

- Donated EVZIO® Auto-injectors Contribute to Lives Saved by First Responders and Community Organizations -

RICHMOND, Va., Aug. 31, 2015 /PRNewswire/ -- Kaléo, a privately-held pharmaceutical company, today announced that EVZIO® (naloxone HCl injection) Auto-Injectors—donated through their charitable donation program, "kaléo Cares,"—have been administered to help save more than 100 lives since inception of the charitable program. EVZIO is the only naloxone product approved for immediate administration as emergency therapy in settings where opioids may be present, such as in a home where most opioid overdose emergencies occur.

kaleo logo

Based on retrospective literature searches and reports from grantees, EVZIO Auto-injectors have helped save at least 126 lives between October 1, 2014 and August 28, 2015. The actual number of lives saved may be higher as there are no mandatory reporting requirements as part of the kaléo Cares program.

"We made it clear from day one that kaléo is determined to help make EVZIO available to all who may benefit, including people in need without traditional insurance coverage," said Spencer Williamson, President and CEO of kaléo. "Since initiating the program in October 2014, our donated EVZIO Auto-injectors have helped save an average of two lives every week." 

The "kaléo Cares Product Donation Program" is intended for certain qualifying non-profit community organizations and first responder agencies demonstrating need. Since the launch of the program, EVZIO Auto-injectors have been donated to 138 first responder agencies or non-profit community-based organizations. 

Since deploying EVZIO in the field on July 13, 2015, police officers in Madison, WI have already used the EVZIO auto-injectors on eight occasions to help save people experiencing opioid emergencies. "Thanks to the generous donation of the EVZIO talking naloxone auto-injectors provided through a grant process from kaléo, my line officers, supervisors, detectives and even command staff feel empowered to confidently administer a life-saving drug in a timely fashion," said Madison Police Chief, Joel Despain. "The ability for an officer to literally save a life-- could there be a better illustration of what a 'guardian' should be doing for the community?"

In opioid emergencies, such as an accidental overdose, seconds count, and immediate treatment can be the difference between life and death. "In the past, loved ones had few options during an opioid emergency other than to call 911 and hope EMS arrived in time," said Eric S. Edwards, MD, PhD, Chief Medical Officer of kaléo. "EVZIO is the only naloxone product that provides visual and voice instructions to help make it easy to administer naloxone during a stressful opioid emergency. Studies demonstrate, on average, 94 percent of users can correctly administer EVZIO without training, and 100 percent with training."

"After hearing about Live4Lali's work to fight the opioid overdose epidemic in the Chicago area, kaléo made a generous donation of EVZIO," said Chelsea Laliberte, the Executive Director of Live4Lali, Inc., a non-profit community group. "That donation has already helped save lives and means fewer mothers burying their children and fewer communities rocked by tragedy. The compassion and commitment kaléo has shown to those affected by the opioid overdose crisis is unparalleled." 

EVZIO, available in the United States by prescription, provides a proven injectable route of administration. The needle is not visible before, during or after injection. There is no generic equivalent to EVZIO.

For more information about "kaléo Cares" or to apply for a charitable product donation, please visit www.kaleopharma.com/who-we-are/kaleo-cares/.

About Opioid-Induced Respiratory Depression (OIRD) and Overdose.

Opioid emergencies, such as an accidental overdose, are a growing public health epidemic. Sixty-seven (67) people die from opioids, including prescription opioid analgesics and heroin, every day in the United States; most occur outside of medical settings, such as in a home.1 Approximately 136,000 opioid overdose emergency department visits occur each year.2  Many communities throughout the United States are facing a devastating heroin epidemic. Additionally, there are two times the number of prescription opioid-related deaths as compared to heroin-related deaths. On average, 3,300 children five years old and younger are admitted to emergency departments each year due to accidental opioid exposure.3

Life-threatening opioid emergencies result in respiratory and/or central nervous system depression. Opioid-Induced Respiratory Depression (OIRD) is the most important serious adverse effect of opioids as it can be immediately life-threatening. In addition to the clear risk of an opioid overdose associated with an opioid use disorder, there may be an increased risk of life-threatening OIRD, even when patients take a prescribed dose of an opioid as directed. For example, taking high doses, taking an opioid in combination with other drugs (e.g., benzodiazepines) or alcohol, or if there is a history of certain medical conditions (e.g., COPD, severe asthma) places individuals at significantly higher risk for life-threatening OIRD. Seconds count when a life-threatening OIRD event occurs. Without rapid intervention, brain injury or death can occur within minutes. Most life-threatening OIRD emergencies occur in the home and are witnessed by family and friends who may be in the best position to intervene quickly.

Naloxone is an opioid antagonist that displaces opioids from the receptors in the brain, temporarily reversing the life-threatening breathing problems that can occur during an opioid emergency.

About EVZIO (EVV-zee-oh)

EVZIO 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. EVZIO is intended for immediate administration as emergency therapy in settings where opioids may be present. EVZIO is not a substitute for emergency medical care.  EVZIO is the only naloxone product with an intelligent voice and visual instruction system designed to help guide a caregiver or family member confidently through a highly stressful opioid emergency. Results averaged across two independent studies demonstrate more than 94 percent of users can correctly administer EVZIO without training, and 100 percent with training.4 Each EVZIO pre-filled, single-use, hand-held auto-injector delivers a single 0.4 mg dose of naloxone HCl injection. Each EVZIO prescription comes with two auto-injectors and a trainer. For more information on EVZIO, visit www.EVZIO.com.

Three out of four insured Americans are covered for EVZIO.4 Based on the latest information, the median out of pocket cost for patients who have received EVZIO is $17 for a prescription that includes two auto-injectors and a trainer.2 Individuals with commercial insurance may be eligible to have EVZIO mailed directly to their home for a $0 copay. EVZIO is also covered broadly by government insurance plans including the U.S. Veterans Administration, Tricare and the majority of state Medicaid programs.2 For details on specific plans, please visit http://evzio.com/hcp/resources/insurance-coverage.php

Uninsured individuals who are not qualified for Medicare or Medicaid, and are experiencing financial difficulties, may be eligible to receive EVZIO at no cost through the kaléo Cares Patient Assistance Program. For more information, please visit http://EVZIO.com/patient/savings-support/patient-assistance-program.php.

EVZIO IMPORTANT SAFETY INFORMATION

EVZIO is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the ingredients in EVZIO.

The following warnings and precautions should be taken when administering EVZIO:

  • Due to the duration of action, keep the patient under continued surveillance and repeated doses of naloxone should be administered, as necessary, while awaiting emergency medical assistance.
  • Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.
  • Reversal of respiratory depression by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete.
  • Use in patients who are opioid dependent may precipitate acute abstinence syndrome.
  • Patients with pre-existing cardiac disease or patients who have received medications with potential adverse cardiovascular effects should be monitored in an appropriate healthcare setting.
  • In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated.

The following adverse reactions have been identified during use of naloxone hydrochloride in the postoperative setting: hypotension, hypertension, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest. Death, coma, and encephalopathy have been reported as sequelae of these events. Excessive doses of naloxone hydrochloride in postoperative patients have resulted in significant reversal of analgesia and have caused agitation.

Abrupt reversal of opioid effects in persons who were physically dependent on opioids has precipitated signs and symptoms of opioid withdrawal including: body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, and tachycardia. In the neonate, opioid withdrawal signs and symptoms also included: convulsions, excessive crying, and hyperactive reflexes.

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. For full Prescribing Information visit http://evzio.com/pdfs/Evzio%20PI.PDF.

About kaléo (kuh-LAY-oh)

Kaléo is a pharmaceutical company dedicated to building innovative solutions for serious and life-threatening medical conditions.  On April 3, 2014, the FDA approved EVZIO, the only naloxone product approved for immediate administration by family members or caregivers as emergency therapy for the treatment of known or suspected opioid overdose in settings where opioids may be present. The company's first product approval, Auvi-Q® (www.Auvi-Q.com) (Allerject® in Canada), was licensed to Sanofi which launched the product in early 2013. 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 with the goal of achieving superiority and cost effectiveness. Kaléo is a privately-held company headquartered in Richmond, Virginia. For more information, visit www.kaleopharma.com.

1 Centers for Disease Control and Prevention. Specific Drugs involved in Drug Poisoning Deaths, 2008-2013.http://www.cdc.gov/nchs/pressroom/heroin_deaths.pdf. Accessed July 21, 2015
2 Yokell et al. Presentation of Prescription and Nonprescription Opioid Overdoses to US Emergency Departments. JAMA Int. Med. 2014; 174(12):2034-7.
3 Burghardt L, et al. Adult Prescription Drug Use and Pediatric Medication Exposures and Poisonings. Pediatrics. 2013; 132:18-27.
4 EVZIO (Naloxone Hydrochloride Injection) Auto-injector [Data on File]. Richmond, VA: Kaleo, Inc.

Contact: Mark Herzog
kaléo
[email protected] 
804-545-6360 (office) 

Logo - http://photos.prnewswire.com/prnh/20150830/262125LOGO

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/more-than-100-lives-reported-saved-since-launch-of-the-kaleo-cares-evzio-naloxone-hcl-injection-donation-program-300134997.html

SOURCE kaleo

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
The platform combines the strengths of Singtel's extensive, intelligent network capabilities with Microsoft's cloud expertise to create a unique solution that sets new standards for IoT applications," said Mr Diomedes Kastanis, Head of IoT at Singtel. "Our solution provides speed, transparency and flexibility, paving the way for a more pervasive use of IoT to accelerate enterprises' digitalisation efforts. AI-powered intelligent connectivity over Microsoft Azure will be the fastest connected pat...
There are many examples of disruption in consumer space – Uber disrupting the cab industry, Airbnb disrupting the hospitality industry and so on; but have you wondered who is disrupting support and operations? AISERA helps make businesses and customers successful by offering consumer-like user experience for support and operations. We have built the world’s first AI-driven IT / HR / Cloud / Customer Support and Operations solution.
ScaleMP is presenting at CloudEXPO 2019, held June 24-26 in Santa Clara, and we’d love to see you there. At the conference, we’ll demonstrate how ScaleMP is solving one of the most vexing challenges for cloud — memory cost and limit of scale — and how our innovative vSMP MemoryONE solution provides affordable larger server memory for the private and public cloud. Please visit us at Booth No. 519 to connect with our experts and learn more about vSMP MemoryONE and how it is already serving some of...
Darktrace is the world's leading AI company for cyber security. Created by mathematicians from the University of Cambridge, Darktrace's Enterprise Immune System is the first non-consumer application of machine learning to work at scale, across all network types, from physical, virtualized, and cloud, through to IoT and industrial control systems. Installed as a self-configuring cyber defense platform, Darktrace continuously learns what is ‘normal' for all devices and users, updating its understa...
Codete accelerates their clients growth through technological expertise and experience. Codite team works with organizations to meet the challenges that digitalization presents. Their clients include digital start-ups as well as established enterprises in the IT industry. To stay competitive in a highly innovative IT industry, strong R&D departments and bold spin-off initiatives is a must. Codete Data Science and Software Architects teams help corporate clients to stay up to date with the mod...
As you know, enterprise IT conversation over the past year have often centered upon the open-source Kubernetes container orchestration system. In fact, Kubernetes has emerged as the key technology -- and even primary platform -- of cloud migrations for a wide variety of organizations. Kubernetes is critical to forward-looking enterprises that continue to push their IT infrastructures toward maximum functionality, scalability, and flexibility. As they do so, IT professionals are also embr...
Platform9, the leader in SaaS-managed hybrid cloud, has announced it will present five sessions at four upcoming industry conferences in June: BCS in London, DevOpsCon in Berlin, HPE Discover and Cloud Computing Expo 2019.
At CloudEXPO Silicon Valley, June 24-26, 2019, Digital Transformation (DX) is a major focus with expanded DevOpsSUMMIT and FinTechEXPO programs within the DXWorldEXPO agenda. Successful transformation requires a laser focus on being data-driven and on using all the tools available that enable transformation if they plan to survive over the long term. A total of 88% of Fortune 500 companies from a generation ago are now out of business. Only 12% still survive. Similar percentages are found throug...
When you're operating multiple services in production, building out forensics tools such as monitoring and observability becomes essential. Unfortunately, it is a real challenge balancing priorities between building new features and tools to help pinpoint root causes. Linkerd provides many of the tools you need to tame the chaos of operating microservices in a cloud native world. Because Linkerd is a transparent proxy that runs alongside your application, there are no code changes required. I...
In his general session at 21st Cloud Expo, Greg Dumas, Calligo’s Vice President and G.M. of US operations, discussed the new Global Data Protection Regulation and how Calligo can help business stay compliant in digitally globalized world. Greg Dumas is Calligo's Vice President and G.M. of US operations. Calligo is an established service provider that provides an innovative platform for trusted cloud solutions. Calligo’s customers are typically most concerned about GDPR compliance, application p...
Modern software design has fundamentally changed how we manage applications, causing many to turn to containers as the new virtual machine for resource management. As container adoption grows beyond stateless applications to stateful workloads, the need for persistent storage is foundational - something customers routinely cite as a top pain point. In his session at @DevOpsSummit at 21st Cloud Expo, Bill Borsari, Head of Systems Engineering at Datera, explored how organizations can reap the bene...
"NetApp's vision is how we help organizations manage data - delivering the right data in the right place, in the right time, to the people who need it, and doing it agnostic to what the platform is," explained Josh Atwell, Developer Advocate for NetApp, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
Druva is the global leader in Cloud Data Protection and Management, delivering the industry's first data management-as-a-service solution that aggregates data from endpoints, servers and cloud applications and leverages the public cloud to offer a single pane of glass to enable data protection, governance and intelligence-dramatically increasing the availability and visibility of business critical information, while reducing the risk, cost and complexity of managing and protecting it. Druva's...
Kubernetes as a Container Platform is becoming a de facto for every enterprise. In my interactions with enterprises adopting container platform, I come across common questions: - How does application security work on this platform? What all do I need to secure? - How do I implement security in pipelines? - What about vulnerabilities discovered at a later point in time? - What are newer technologies like Istio Service Mesh bring to table?In this session, I will be addressing these commonly asked ...
BMC has unmatched experience in IT management, supporting 92 of the Forbes Global 100, and earning recognition as an ITSM Gartner Magic Quadrant Leader for five years running. Our solutions offer speed, agility, and efficiency to tackle business challenges in the areas of service management, automation, operations, and the mainframe.