FDA Approves Evzio Opioid Drug Overdose Auto-Injector Device
The U.S. Food and Drug Administration announced Thursday that it approved the use of a portable opioid overdose treatment device named Evzio. The hand-held auto-injector is designed for family members or caregivers of a known or suspected opioid user to administer the medication in the occurrence of an overdose.
Evzio, created by the pharmaceutical company Kaleo Inc., contains naloxone hydrochloride that rapidly reverses the effects of a drug overdose, which can be decreased breathing, slowed heart rates and loss of consciousness, according to the FDA's press release.
According to the Center for Disease Control, the annual amount of overdose deaths has steadily increased during the last decade and a half and surpassed motor vehicle collision deaths in 2010.
Dr. Bob Rappaport, director of the Division of Anesthesia, Analgesia and Addiction Products for the FDA's Center for Drug Evaluation and Research, said in the press release that the rise of overdose deaths has prompted the White House and drug administration's call to action.
"Overdose and death resulting from misuse and abuse of both prescription and illicit opioids has become a major public health concern in the United States," Rappaport said. "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."
The CDC found in its most recent report last year that 38,329 people died in the U.S. in 2010 from drug overdose, which increased from 27,004 deaths in 2009 and 16,849 deaths in 1999. Motor vehicle accidents accounted for 35,332 deaths in 2010, while all drug induced deaths amounted to 40, 393 of the nearly 2.5 million deaths that year.
The leading cause of death in 2010 was diseases of heart, which took 780,213 lives.
Pharmaceutical drugs were the cause of roughly 58 percent of the overdose deaths that occurred in 2010 -- 22,134 people -- while the remaining 16,651 were caused by pharmaceutical opioid analgesics including oxycodone, hydrocodone and methadone, according to the CDC.
About 30 percent of the total overdose deaths involved anti-anxiety drugs, 18 percent were caused by antidepressants, and six percent were found to involve antipsychotic drugs.
Kaleo manufactures a line of personal medical-care products with treatment drugs that can be used and administered in potentially life-threatening situations at home or away from a hospital.
Opioids are a type of pain medication used to treat acute and chronic medical conditions in about 100 million adults in the U.S., according to a Kaleo press release. Because of the opioids highly sensitive nature, overdoses can occur if even a single extra dose is administered or the person consumed with a small amount of alcohol.
Kaleo Chief Executive Officer Spencer Williamson said in the press release the FDA's approval is an important step to curbing overdose deaths in the nation.
"The FDA approval of Evzio furthers our mission to make lifesaving products that put patients first, Williamson said. "We are thankful to the patients and caregivers whose input guided the development process and resulted in an intuitive important product we're proud to bring to market."
The FDA said Evzio was tested on 30 patients in a pharmacokinetic study and found that when comparing a single injection of the hand-held device to a single dose injection with a standard syringe, the amount of naloxone were equivalent.
The product was fast-tracked by the FDA as part of the agency's priority review program that places the drugs and products meant to treat critical public health need where "no satisfactory alternative therapy exists" ahead of other reviews.
Dr. Douglas Throckmorton said he and his team of researchers reviewed Evzio for the last 15 weeks and also said that the device will provide the FDA a new tool in its arsenal to combat opioid overdose.
"Tackling the epidemic of opioid abuse and misuse is a high priority for the Food and Drug Administration," Throckmorton said. "While these pain relievers has provided tremendous benefits for many, their abuse has reached epidemic levels in the United States with devastating consequences to families."
He said that the FDA has been working with other federal agencies and scientists to improve the understanding of pain and how to treat it as well as finding non-opioid treatments.
"Tackling this complex problem requires a comprehensive and coordinated approach with our federal partners," he said, adding, "and I'm delighted to say that we have worked closely with many other federal agencies."
Throckmorton said the FDA's use of the expedited review program helped them "to advance the development of new, non-opioid medications to treat pain with the goal of bringing new or less abuse-able products to the market."
The FDA said naloxone is the standard treatment for overdose and are typically administered by emergency medical staff. Although the device ideally saves the person's life, the family member or caregiver is still responsible for seeking further medical action.
The device is equipped with an automated verbal instruction player that tells the user how to deliver the medication to the patient overdosing. The Evzio package will also include a trainer device so family members and caregivers can become more familiar with the device prior to using it on a patient, according to the FDA.
The Substance Abuse and Mental health Services Administration released its Opioid Overdose Toolkit last August and is aimed at providing communities, local governments and first responders with information on how to treat opioid abuse, addiction and overdose.