FDA Approves Convenient Opioid Overdose Antidote

  • The number of opioid overdose deaths has been rapidly increasing over the past two decades. According to the Center for Disease Control over 37,004 died in 2010 compared to 16,489 in 1999. In order to curtail these alarming figures, lawmakers have tried a “war on drugs,” public health education campaigns, and stricter prescribing laws. As the numbers continue to climb, lawmakers in California and other states have tired a different approach by giving liability protection to all healthcare providers in the state that help to distribute and prescribe the overdose antidote: Naloxone (a.k.a. Narcan). As a result of these legal efforts, the FDA has just approved a convenient-to-use Naloxone product called Evzio.

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    Naloxone has been used for a long time in emergency rooms to reverse the effects of opioids in the event of an overdose. Of course, the efficacy of an antidote available only in a hospital hinges on a person actually making it to the emergency room in time to survive an overdose. Now with these new laws and products, saving the life of someone who is in the grips of death can be done by friends, associates, family members and other witnesses that administer the antidote themselves,. Community-wide distribution of Naloxone has been happening in San Francisco since 2003, the longest-running such program in the country. Since the availability of the overdose antidote has steadily increased in this city, the numbers of overdose deaths has been dropping dramatically. The average rate of opioid overdose deaths in San Francisco ten years ago was 120, now it is only 10.


    Because opioid overdose prevention program is actually working thanks to better accessibility, a pharmaceutical company developed a Naloxone product that will assist in the efforts called Evzio. Instead of making hand making kits that contain Naloxone with written instructions for the layperson; now all that is needed is Evzio, a device that is pre-loaded with the right dose and will talk someone through the administration of the antidote, similar to an automatic defibrillator.


    “Evzio is the first combination drug-device product designed to deliver a dose of naloxone for administration outside of a health care setting. Making this product available could save lives by facilitating earlier use of the drug in emergency situations,” according to Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia, and Addiction Products in the FDA’s Center for Drug Evaluation and Research.


    Early intervention does prevent deaths and further need for life-support. Naloxone is safe for public-wide use because there are relatively few contra-indications and side-effects. Once a person has received education about how to recognize signs of an overdose like: slow breathing, inability to wake up, and “bad reaction”, that person can have Naloxone in their possession, ready to use. Of course, this is not intended to replace emergency services from being activated in the event of an overdose. When survival is measured in minutes, a witness can quickly do both: activate emergency services and administer the antidote.


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    The “Good Samaritan” that administered the antidote and the “good doctor” that prescribed the opioid overdose antidote, Naloxone, are protected by law in the following states thus far as of March 2014: NM, WA, NY, CT, IL, CO, RI, FL, MA, CA, NC, NJ, VT, DE and District of Columbia. Expect more states to follow this precedence because lives are being saved from the throes of a premature death due to opioid drug overdose.


    For further information about Opioid Overdose Prevention Programs visit:


Published On: April 06, 2014