|By PR Newswire||
|April 3, 2014 10:43 AM EDT||
RICHMOND, Va., April 3, 2014 /PRNewswire/ -- Kaleo (formerly Intelliject) today announced that the U.S. Food and Drug Administration (FDA) has approved EVZIO™ (naloxone hydrochloride injection) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. EVZIO is the first and only naloxone auto-injector intended to be available for immediate administration by family members or caregivers for suspected opioid overdose in settings where opioids may be present.1
Opioids are part of a class of pain medications that work by binding to receptors in the brain that affect the body's perception of pain, and can cause fatal overdose when the amount of drug in the body is too high.2 Opioids are used to treat pain associated with a variety of acute and chronic medical conditions. According to the Institute of Medicine, chronic pain affects about 100 million American adults – more than the total affected by heart disease, cancer and diabetes combined.3 More than 16,000 Americans die each year from prescription opioid overdose, and accidental drug poisoning has surpassed automobile collisions as the leading cause of accidental death in the U.S., driven largely by prescription opioids.4,5
Naloxone, the active ingredient in EVZIO, has been used for more than 40 years for reversal of respiratory depression due to opioid overdose, but has been primarily used by emergency medical services, other medical professionals and in limited naloxone distribution programs.6 EVZIO will be available to patients and their family members or caregivers via a healthcare professional's prescription. EVZIO should be administered as quickly as possible when an opioid overdose is suspected because prolonged respiratory depression may result in damage to the central nervous system or death. Because people experiencing an opioid overdose generally lose consciousness, in most cases, family members or caregivers will likely be the ones who administer EVZIO. EVZIO uses voice and visual cues to assist in guiding a user through the injection process.1
"Kaleo was founded on the idea that patients are true experts on how their conditions impact their lives, and EVZIO was developed with patient and caregiver input throughout to make sure it would be easy to use in stressful opioid emergencies with limited training," said Eric Edwards, MD, PhD, Chief Medical Officer of kaleo. "Immediate availability of EVZIO for family members and caregivers to administer during a suspected opioid overdose has the potential to save many lives."
"All patients taking an opioid pain medication accept some risk of potential overdose. No medication is side effect free, and potent pain relieving opioids have a narrow window of effectiveness, with some very serious possible side effects including potentially life-threatening respiratory depression," said Allen Burton, MD7, anesthesiologist and pain specialist at Houston Pain Centers and former chairman of the department of pain medicine at the University of Texas MD Anderson Cancer Center. "Until now, most people had to rely on emergency medical care to get access to an opioid reversal agent. Having naloxone available for use by caregivers as soon as signs of overdose are observed means an earlier intervention and better chance of survival."
The new drug application (NDA) for EVZIO was granted Fast Track status and received a priority review by the FDA, which are regulatory pathways to accelerate the review and approval of products that fill an unmet medical need. EVZIO is expected to be available this summer through all major pharmacies and via mail order with a healthcare professional's prescription. An assistance program will be available to help patients gain access to EVZIO.
"The FDA approval of EVZIO furthers our mission to make lifesaving products that put patients first," said Spencer Williamson, CEO of kaleo. "We are thankful to the patients and caregivers whose input guided the development process and resulted in an intuitive and important product we're proud to bring to market."
For more information on EVZIO, visit www.EVZIO.com.
Conference Call for Media
Kaleo will host a briefing for members of the media on Thursday, April 3, 2014, at 12 p.m. ET. Media can call 1-888-771-4371, confirmation number 37036155. The panel of speakers will include:
- Spencer Williamson, CEO of kaleo
- Eric Edwards, MD, PhD, Chief Medical Officer of kaleo
- Allen Burton, MD, anesthesiologist and pain specialist
- Knox H. Todd, MD, MPH, FACEP, emergency physician
About Opioid Overdose
Opioid overdose can cause a person's breathing to severely slow down and even stop. Opioid medications have a relatively narrow therapeutic window, meaning that even small changes – such as a single extra dose or the addition of a small amount of alcohol – can cause a potentially fatal overdose.8
Some risk factors for overdose include: history of substance abuse or dependence, taking high doses of opioids,6 no previous history of taking opioids,9 a recent dosage increase, extended-release or long-acting opioids,10 taking certain antidepressants like monoamine oxidase inhibitors (MAOIs) or certain drugs for anxiety, and a history of respiratory conditions such as asthma, COPD and sleep apnea.6 In addition, children living with someone consuming prescription opioids have been shown to be at increased risk.11
Signs and symptoms of opioid overdose include very slow or absent breathing, loss of consciousness, extremely small pupils, and slow heartbeat.2
EVZIO is a pre-filled, single-use auto-injector that works by temporarily blocking the effect of an opioid, potentially reversing the life-threatening respiratory depression and allowing the recipient to breathe more regularly. Once the effects of EVZIO wear off, the overdose symptoms may reappear and additional naloxone may be required. There is no potential for abuse or dependence with naloxone.1
Each EVZIO delivers 0.4 mg naloxone hydrochloride injection (0.4 mL).
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.
Important Safety Information
The following is important safety information associated with dosing and administration of EVZIO:
- EVZIO is for intramuscular or subcutaneous use only.
- Administer EVZIO to adult or pediatric patients into the anterolateral aspect of the thigh, through clothing if necessary.
- In pediatric patients under the age of one, the caregiver should pinch the thigh muscle while administering EVZIO.
- Seek emergency medical care immediately after use.
- The duration of action of most opioids is likely to exceed that of EVZIO resulting in a return of respiratory and/or central nervous system depression. Keep the patient under continued surveillance and repeated doses of EVZIO should be administered every 2 to 3 minutes, as necessary, while awaiting emergency medical assistance.
- If the electronic voice instruction system does not operate properly, EVZIO will still deliver the intended dose of naloxone hydrochloride when used according to the printed instructions on the flat surface of its label.
The following precautions should be taken when administering EVZIO:
- Consider other supportive and/or resuscitative measures while awaiting emergency medical assistance.
- Reversal of respiratory depression by partial agonists or mixed agonists/antagonists such as buprenorphine and pentazocine, may be incomplete or require higher doses of naloxone.
- Use in patients who are opioid dependent may precipitate acute abstinence syndrome.
- In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated.
- 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.
- EVZIO should be used with caution in patients known to be hypersensitive to naloxone hydrochloride.
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, tachycardia. In the neonate, opioid withdrawal signs and symptoms also included: convulsions, excessive crying, hyperactive reflexes.
Use in Post-Operative Settings:
The following adverse reactions have been identified during use of naloxone hydrochloride in the post-operative 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 post-operative patients have resulted in significant reversal of analgesia and has caused agitation.
Kaleo (formerly Intelliject) is a pharmaceutical company dedicated to putting a new generation of life-saving personal medical products in patients' hands. The company's first product, Auvi-Q™ (www.Auvi-Q.com) (Allerject™ in Canada), was licensed to Sanofi US which launched the product in early 2013. Our mission is to provide demonstrably superior medical products that empower patients and caregivers to confidently take control in potentially life-threatening situations. 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 kaleo product combines an established drug with an innovative delivery platform with the goal of achieving superiority and cost effectiveness. Kaleo is a privately held company headquartered in Richmond, Virginia. For more information, visit www.kaleopharma.com.
©2014 kaleo, Inc. All rights reserved. PP-EVZ-US-0016 April 2014
1 EVZIO Prescribing Information. 2014.
2 SAMHSA Opioid Overdose Prevention Toolkit Safety Advice for Patients. HHS Publication No. (SMA) 13-4742.
3 Institute of Medicine. Relieving Pain in America A Blueprint for Transforming Prevention, Care, Education, and Research. June 2011.
4 National Center for Health Statistics. NCHS data on drug poisoning deaths. http://www.cdc.gov/nchs/data/factsheets/factsheet_drug_poisoning.pdf. Updated December 2012
5 Centers for Disease Control and Prevention. Opioid-related deaths continue to increase. http://media.jsonline.com/images/OPIOIDS20GFIX.jpg.
6 Leavitt, S. Intranasal Naloxone for At-Home Opioid Rescue. Practical Pain Management. Oct 2013.
7 Editor's Note: Dr. Burton has a consulting agreement with kaleo, Inc.
8 Boyer, E. Management of Opioid Analgesic Overdose. N Engl J Med 2012; 367
9 Manchikanti, L. Opioid Epidemic in the United States. Pain Physician. 2012;15;ES9-ES38.
10 Food and Drug Administration. FDA blueprint for prescriber education for extended-release and long-acting opioid analgesics. http:[email protected]/documents/.... Published 2013
11 Burghardt, L. et al. Pediatrics. Adult Prescription Drug Use and Ped. Medication Exposure 2013
SYS-CON Events announced today that Isomorphic Software will exhibit at DevOps Summit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Isomorphic Software provides the SmartClient HTML5/AJAX platform, the most advanced technology for building rich, cutting-edge enterprise web applications for desktop and mobile. SmartClient combines the productivity and performance of traditional desktop software with the simp...
Jul. 29, 2016 10:00 PM EDT Reads: 1,270
"When you think about the data center today, there's constant evolution, The evolution of the data center and the needs of the consumer of technology change, and they change constantly," stated Matt Kalmenson, VP of Sales, Service and Cloud Providers at Veeam Software, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 29, 2016 09:45 PM EDT Reads: 1,484
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 19th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world and ThingsExpo Silicon Valley Call for Papers is now open.
Jul. 29, 2016 08:00 PM EDT Reads: 2,744
We all know the latest numbers: Gartner, Inc. forecasts that 6.4 billion connected things will be in use worldwide in 2016, up 30 percent from last year, and will reach 20.8 billion by 2020. We're rapidly approaching a data production of 40 zettabytes a day – more than we can every physically store, and exabytes and yottabytes are just around the corner. For many that’s a good sign, as data has been proven to equal money – IF it’s ingested, integrated, and analyzed fast enough. Without real-ti...
Jul. 29, 2016 07:45 PM EDT Reads: 1,172
Actian Corporation has announced the latest version of the Actian Vector in Hadoop (VectorH) database, generally available at the end of July. VectorH is based on the same query engine that powers Actian Vector, which recently doubled the TPC-H benchmark record for non-clustered systems at the 3000GB scale factor (see tpc.org/3323). The ability to easily ingest information from different data sources and rapidly develop queries to make better business decisions is becoming increasingly importan...
Jul. 29, 2016 06:15 PM EDT Reads: 952
SYS-CON Events announced today that 910Telecom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...
Jul. 29, 2016 06:00 PM EDT Reads: 922
Big Data, cloud, analytics, contextual information, wearable tech, sensors, mobility, and WebRTC: together, these advances have created a perfect storm of technologies that are disrupting and transforming classic communications models and ecosystems. In his session at @ThingsExpo, Erik Perotti, Senior Manager of New Ventures on Plantronics’ Innovation team, provided an overview of this technological shift, including associated business and consumer communications impacts, and opportunities it ...
Jul. 29, 2016 05:15 PM EDT Reads: 384
Cloud analytics is dramatically altering business intelligence. Some businesses will capitalize on these promising new technologies and gain key insights that’ll help them gain competitive advantage. And others won’t. Whether you’re a business leader, an IT manager, or an analyst, we want to help you and the people you need to influence with a free copy of “Cloud Analytics for Dummies,” the essential guide to this explosive new space for business intelligence.
Jul. 29, 2016 05:15 PM EDT Reads: 983
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
Jul. 29, 2016 04:45 PM EDT Reads: 1,246
WebRTC is bringing significant change to the communications landscape that will bridge the worlds of web and telephony, making the Internet the new standard for communications. Cloud9 took the road less traveled and used WebRTC to create a downloadable enterprise-grade communications platform that is changing the communication dynamic in the financial sector. In his session at @ThingsExpo, Leo Papadopoulos, CTO of Cloud9, discussed the importance of WebRTC and how it enables companies to focus...
Jul. 29, 2016 04:15 PM EDT Reads: 1,081
Qosmos has announced new milestones in the detection of encrypted traffic and in protocol signature coverage. Qosmos latest software can accurately classify traffic encrypted with SSL/TLS (e.g., Google, Facebook, WhatsApp), P2P traffic (e.g., BitTorrent, MuTorrent, Vuze), and Skype, while preserving the privacy of communication content. These new classification techniques mean that traffic optimization, policy enforcement, and user experience are largely unaffected by encryption. In respect wit...
Jul. 29, 2016 04:15 PM EDT Reads: 443
ReadyTalk has expanded the capabilities of the FoxDen collaboration platform announced late last year to include FoxDen Connect, an in-room video collaboration experience that launches with a single touch. With FoxDen Connect, users can now not only engage in HD video conferencing between iOS and Android mobile devices or Chrome browsers, but also set up in-person meeting rooms for video interactions. A host’s mobile device automatically recognizes the presence of a meeting room via beacon tech...
Jul. 29, 2016 04:15 PM EDT Reads: 402
Manufacturers are embracing the Industrial Internet the same way consumers are leveraging Fitbits – to improve overall health and wellness. Both can provide consistent measurement, visibility, and suggest performance improvements customized to help reach goals. Fitbit users can view real-time data and make adjustments to increase their activity. In his session at @ThingsExpo, Mark Bernardo Professional Services Leader, Americas, at GE Digital, discussed how leveraging the Industrial Internet a...
Jul. 29, 2016 03:15 PM EDT Reads: 667
On Dice.com, the number of job postings asking for skill in Amazon Web Services increased 76 percent between June 2015 and June 2016. Salesforce.com saw its own skill mentions increase 37 percent, while DevOps and Cloud rose 35 percent and 28 percent, respectively. Even as they expand their presence in the cloud, companies are also looking for tech professionals who can manage projects, crunch data, and figure out how to make systems run more autonomously. Mentions of ‘data science’ as a skill ...
Jul. 29, 2016 03:00 PM EDT Reads: 464
In his session at Cloud Expo, Robert Cohen, an economist and senior fellow at the Economic Strategy Institute, will provide economic scenarios that describe how the rapid adoption of software-defined everything including cloud services, SDDC and open networking will change GDP, industry growth, productivity and jobs. This session will also include a drill down for several industries such as finance, social media, cloud service providers and pharmaceuticals.
Jul. 29, 2016 02:15 PM EDT Reads: 390