Meeting the Need

The tide of deaths due to unintentional prescription opioid toxicity must be stemmed.

There was a time in the United States when going to your medicine cabinet was much safer than taking a trip in your car. However, the most recent data (2011) reveal that deaths related to drug overdoses surpass the number of deaths caused by motor vehicle accidents. The stark reality is the fact that over 75% of those drug overdose deaths involve prescription opioids. At least 83% of the 16,917 opioid-related deaths were accidental,¹ which means that 1 person dies every 39 minutes from an unintentional opioid overdose.

Clearly, a public health issue, which some have labeled an epidemic, is occurring in our society. The need to stem the tide of deaths that occur each day from unintentional prescription opioid toxicity is obvious. To date, efforts have been limited to increased education surrounding the risks of opioids, programs to assist in identifying and monitoring for opioid abuse, and a small number of community naloxone distribution programs. On April 3, 2014, the FDA announced its approval of EVZIO (naloxone hydrochloride injection) autoinjector, with a proven route of administration and first-in-class indication for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/ or central nervous system depression. It is intended for immediate administration as emergency therapy in settings where opioids may be present and is not a substitute for emergency medical care.²

For the first time, EVZIO makes naloxone available via prescription in a convenient and easy-to-use dosage form for administration by family members and other caregivers in non—health care settings. We recognized the opioid overdose crisis facing America and began development of EVZIO to meet that need. After 5 years of research, and a 15-week priority review process by the FDA, EVZIO was granted approval and is now available in retail pharmacies throughout the United States. You can now place this potentially lifesaving product into the hands of your patients and their caregivers.

EVZIO is consistent with kaléo’s mission, which is to use established drugs, such as naloxone, with the company’s innovative, proprietary technology to deliver products that provide a combination of efficacy, safety, ease of use, and cost-effectiveness. In order to do this, we employ human factors engineering (HFE) to help remove the potential for error during life-threatening situations. In your pharmacy setting, you witness the confusion, and hear the concern in the voices, of patients and family members at the thought of administering a medication incorrectly. Add the stress and anxiety of facing a life-threatening situation during an opioid overdose, and the potential for serious harm is real. HFE takes what we know about our own human limitations and applies it to create a more intuitive, instinctive product.

The use of HFE created a product that uses visual and audio cues to assist in guiding caregivers and family members through the correct administration process. This is because many individuals who may need to respond to an opioid overdose emergency may have never been trained on how to administer naloxone. Approximately the size of a credit card and thickness of a small cell phone, EVZIO can easily slip into a pocket or purse. The auto-injector contains a fully retractable needle system, so the needle is never seen before, during, or after injection; this helps to prevent the potential for infectious disease transmission. The product is designed so that the voice prompts move at the pace of the users, and they do not require the voice instructions to be complete before moving to the next step.

As the pharmacist, it is important for you to know that the trade package comes with 2 prefilled, single-use EVZIO autoinjectors, each with 0.4 mg of naloxone as well as a separate trainer for practice. You can differentiate the trainer from the EVZIO auto-injectors by their labels. The trainer label is black and white, while the EVZIO auto-injector labels are purple and yellow. Trainers have been provided to pharmacists for hands-on education with patients, family members, or other caregivers, and additional trainers are available upon request. Kaléo is proud to be bringing EVZIO to market. We believe that with the assistance of the entire health care professional community, EVZIO will help reduce the number of deaths that occur every year due to unintentional opioid overdose. Be sure to view the important safety information for EVZIO as well as additional educational material by visiting www.evzio.com.

Dr. Eric Edwards is the chief medical officer and vice president of research and development at kaléo. He is the co-inventor of EVZIO. Dr. Edwards received his MD at the School of Medicine and PhD in pharmaceutical science at the School of Medicine at Virginia Commonwealth University. He is an affiliate faculty member at the School of Pharmacy, where he instructs pharmacy students in the use of specialty injectable pharmaceuticals intended for self-administration as well as the regulation of drug/device combination products.

References

• Vital signs: variation among States in prescribing of opioid pain relievers and benzodiazepines—United States, 2012. Centers for Disease Control and Pre­vention website. www.cdc.gov/mmwr/preview/mmwrhtml/mm6326a2.htm?s_cid=mm6326a2_w. Accessed July 15, 2014.
• EVZIO [prescribing information]. Richmond, VA: kaleo, Inc; 2014.