Thousands of lives can now be saved thanks to the approval of the U.S. Food and Drug Administration (FDA) of a medical device that can prevent opioid overdose. The device is called Evzio and it operates like the epinephrine injector, also known as the EpiPen, which is used for allergic reactions. No training is required to inject it intramuscularly, which makes it user-friendly and can be easily administered. Anyone from caregivers to family members can inject a potent dose of Naloxone with the easy to use injector. The device walks the caregiver through the process of administering the drug through recorded verbal instructions. However, prescription for the product must be obtained first.
Overdosing is characterized by slowing down of respiratory functions, fatigue and change in heart rate. Naloxone has long been used as an antidote that fights all these symptoms caused by powerful painkillers like OxyCotin and Vicodin and even illegal drugs like heroin. The device quickly delivers Naloxone to the system to stop the action of the opiods that can fatally slow down breathing. While previously Naloxone was administered only by hospital and ambulance staff, now non-medical personnel will be able to store and use the drug like any other prescription medicine.
Over 16,000 deaths are recorded annually due to prescription drug overdose. In a pilot program conducted by the police officers in Suffolk County, emergency administration Naloxone saved over 500 lives. So only after 15 weeks of priority status, Evzio has been given full approval by the FDA. “For years, the lack of a lay-friendly delivery system has made it difficult to make Naloxone broadly available to the public and to foster its use in non-medical settings, where it is often most urgently needed,” Margarent A. Hamburg, FDA Commisioner, told reporters when asked.
The kit costs $60 and has a shelf life of 2 years. Each kit is equipped with two syringes, pre-filled with the drug. However, as New York Attorney General Eric Schneiderman said, Naloxone can bring overdose victims back “from the brink of death and buys more time to get to a hospital.” Regulators have warned that Evzio is an emergency measure only and not a substitute for proper medical care. Although it could make the difference between life and death, Naloxone only temporarily counters the effects of overdose. After the effect of Naloxone wears off, withdrawal symptoms like nausea, sweating profusely, uncontrollable shivering and high blood pressure are noted in most overdose victims. The victim must be immediately taken to a medical facility for treatment.
The makers of Evzio are focused on making the product available to everyone. “This is an important milestone for the millions of patients taking opioids who are trying to balance pain management with the safe use of opioids, as well as those who are struggling with abuse. What we’ve realized is that opioid overdoses do not discriminate- We want to make sure this product is made available to all who could benefit from it,” said Eric Edwards, chief medical officer of Kaleo, the manufacturer of Evzio.