Prescription drug overdose deaths are now the leading cause of injury death in the U.S even surpassing motor vehicle crashes. FDA Commissioner Margaret A. Hamburg reports “FDA is working to strengthen prescription drug surveillance efforts to actively monitor the changing nature of prescription opioid abuse and identify emerging issues related to abuse.
Kaleo Inc. the maker of Evzio at www.kaleopharma.com a privately held company headquartered in Richmond, announced that FDA has approved the hand-held device called Evzio at www.EVZIO.com. This is the first and only nalozone auto-injector that can be used to treat a person known or suspected to have had an opioid overdose characterized by decreased breathing or heart rate or by loss of consciousness.
Naloxone the active ingredient in Evzio has been used for more than forty years but now Evizo will be able to make nalozone immediately available to patients and their family members or caregivers via a healthcare professional’s prescription in an emergency. For the first time, people with no or little medical knowledge will be able to inject the drug Nalozone.
Evizo injects naloxone into the muscle or under the skin. Once turned on, the device provides verbal instructions to the user describing how to deliver the medication which is similar to using automated defibrillators. Family members or caregivers should become familiar with all the steps for using Evzio and practice with the trainer device.
According to Eric Edwards, MD, PhD, CMO of Kaleo, “Immediate availability of Evzio for family members and caregivers to administer during a suspected opioid overdose has the potential to save many lives.”
The new drug application for Evzio was granted Fast Track status and received a priority review by the FDA to accelerate the review and approval of the device. The approval was granted within 15 weeks and Evzio is expected to be available this summer in all major pharmacies and via mail order with a healthcare professional’s prescription.
Realizing the seriousness of prescription drug abuse in terms of death, many states are working hard to fight prescription drug abuse. Many states have set up a Prescription Drug Monitoring Program (PDMP) which is a statewide electronic database that collects designated data on substances dispensed in the state.
The PDMP is housed by a specified statewide regulatory, administrative, or law enforcement agency. The agency housing the database distributes data from the database to individuals who are authorized under state law to receive the information. The major goal for the states is to provide tighter monitoring of prescriptions to prevent doctor shopping and to lower or prevent the illicit sale of prescription drugs.