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news.Kaleo has announced the US commercial availability of EVZIO for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
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The company said that EVZIO is not a substitute for emergency medical care and it is approved by the US Food and Drug Administration (FDA) in April 2014.
The product is the first and only naloxone product labeled for immediate administration by family members or caregivers.
Kaleo CEO Spencer Williamson said opioid overdose is a significant and growing public health concern in America and until now, there have been limited options available for the rapid administration of this potentially life-saving drug in non-healthcare settings.
"We are pleased to be able to make EVZIO available soon after receiving approval by the FDA," Williamson said.
Currently, EVZIO is available in the US by prescription and it should be administered as quickly as possible when an opioid overdose is suspected because prolonged respiratory depression may result in damage to the central nervous system or death.
Kaleo vice president of Product Development Evan Edwards said EVZIO is the first and only FDA approved naloxone auto-injector specifically designed to be used by individuals without medical training.
"Additionally, using kaleo’s comprehensive human factors engineering process, EVZIO was designed and validated for use by family members and caregivers," Edwards said.