Naloxone: The Second Chance Drug Now Available as Evzio

evzioNaloxone (also called Narcan) is the antidote used to reverse an opioid overdose. It has been used to reverse opioid reactions in hospitals and by EMT's for decades. Naloxone works by neutralizing opioids in a person's system and by helping the lungs function allowing people to breathe. It only works if a person has opioids in his or her system; it doesn't work on other types of medications. It has been found to be safe for almost everyone and has been used all over the world to effectively reverse the effects of opioid overdose. The Centers for Disease control and Prevention (CDC) reports that more than 10,000 reversals of overdoses with administration of naloxone by non-medical bystanders have been recorded! Up until last week's FDA approval of Evzio, a product of Kaléo a pharmaceutical company, there have been two types of naloxone dispensing methods: 1) a nasal spray that can be squirted into the nose and 2) an injected form that can be administered through clothing into a muscle. Until the approval98+6Both of these medications had to be given by a medical professional, usually in an emergency room setting or by an EMT in an ambulance on the way to the emergency room. This is the first time naloxone has been put into a form that can be prescribed and used directly by patients and is not reliant on administration by hospital or other medical facility professionals, including EMTs.

Evzio is a take-home, single-use naloxone auto-injector that may be used wherever opioids are present. If an opioid overdose occurs, a family member or caregiver can use Evzio to temporarily reverse the effects of the opioid and help keep the patient breathing until emergency medical assistance is available. It is easy to use with visual and voice instruction guidance and comes in a compact size that facilitates portability and availability in an emergency. Its retractable needle system helps prevent user exposure to the needle. Evzio can also be prescribed to an opioid user family member or caregiver.
Read the FDA Evzio Press Release . . . 

Released: April 3, 2014
Consumer Inquiries: 888-INFO-FDA
FDA Commissioner Margaret A. Hamburg Statement on Prescription Opioid Abuse

For more than a decade, the U.S. Food and Drug Administration has been working to address the important public health problems associated with the misuse, abuse, addiction and overdose of opioid analgesics, while at the same time working to ensure continued access to effective and appropriate medications for millions of Americans currently suffering from pain. I firmly believe that these goals are compatible, and that actions to address one should not be at the expense of the other.

Tragically, the most recent data shows that more than 16,000 lives are lost each year due to opioid-related overdoses. In fact, drug overdose deaths, driven largely by prescription drug overdose deaths, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. We know that the illegal diversion, misuse, and abuse of prescription opioids are often fueled by inappropriate prescribing, improper disposal of unused medications, and the illegal activity of a small number of health care providers. This highlights the important role that education of prescribers and patients can play in addressing this epidemic. The FDA has taken steps to address this but more work remains to be done.

Combatting the serious public health problem of misuse, abuse, addiction and overdose from opioid analgesics is a high priority. Since 2001 the FDA has taken a number of actions designed to help address prescription opioid abuse and to encourage the development of new drug treatments for pain. These actions include:

  • Revising the labeling for opioid medications to foster their safe and appropriate use, including recent changes to the indications and safety warnings of extended-release and long-acting opioids.
  • Requiring that manufacturers conduct studies of the safety of long-term use of prescription opioids.
  • Improving appropriate prescribing by physicians and use by patients through educational materials required as a part of a risk mitigation strategy for extended-release and long-acting opioids.
  • Using the agency's expedited review programs to advance development of new non-opioid medications to treat pain with the goal of bringing new non- or less-abusable products to market.
  • Working with other federal agencies and scientists to advance our understanding of the mechanisms for pain and how to treat it, including the search for new non-opioid medications for pain.
  • Recommending that hydrocodone-containing combination products have additional restrictions on their use by rescheduling them from Schedule III to Schedule II.
  • Strengthening surveillance efforts to actively monitor the changing nature of prescription opioid abuse and to identify emerging issues.
  • And, importantly, encouraging the development of medications to treat opioid abuse, such as buprenorphine for use in medication-assisted treatment, and to reverse opioid overdoses, such as naloxone.
Today's FDA approval of Evzio (naloxone autoinjector) provides an important new tool in our arsenal to more effectively combat the devastating effects of opioid overdose, which is one part of our comprehensive work to support opioid safety. Reflecting the FDA's commitment to encouraging important new therapies, the FDA's review of Evzio was granted priority status, and the application was reviewed by the FDA in just 15 weeks.

This product is the first auto-injector designed to rapidly reverse the overdose of either prescription or illicit opioids. While the larger goal is to reduce the need for products like these by preventing opioid addiction and abuse, they are extremely important innovations that will help to save lives.

The FDA will continue to work to reduce the risks of abuse and misuse of prescription opioids, but we cannot solve this complex problem alone. A comprehensive and coordinated approach is needed; one that includes the White House Office of National Drug Control Policy, the Drug Enforcement Administration and many of our sister agencies within the Department of Health and Human Services, as well as state and local governments, public health experts, health care professionals, addiction experts, researchers, industry, and patient organizations.

I am confident that this can be accomplished, but we will all need to work together to invest in strategies and responsible approaches that deter or mitigate the effects of abuse while preserving access to pain medicines for the patients that need them the most.

For More Information: Information on Opioid Medications
News Release: FDA approves new hand-held auto-injector to reverse opioid overdose

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