Kaléo, a privately-held pharmaceutical company, has launched Evzio (naloxone HCl injection) in US markets for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Evzio is not a substitute for emergency medical care. Evzio, approved by the US Food and Drug Administration (FDA) on April 3, 2014, is the first and only naloxone product labeled for immediate administration by family members or caregivers.

Evzio is a pre-filled, single-use, hand-held auto-injector that works by temporarily blocking the effect of an opioid, potentially reversing the life-threatening respiratory depression and allowing the recipient to breathe more regularly. Each Evzio delivers a single 0.4 mg dose of naloxone HCl injection. Since the duration of action of most opioids may exceed that of naloxone, seek immediate emergency medical assistance, keep the patient under continued surveillance, and administer repeated doses of Evzio as necessary.

“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,” said Spencer Williamson, CEO of kaléo. “We are pleased to be able to make Evzio available soon after receiving approval by the FDA.”

Evzio is now available in the United States by prescription. Evzio 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. Because people experiencing an opioid overdose generally lose consciousness, in most cases, family members or caregivers will likely be the ones who administer Evzio. Evzio uses voice and visual cues to assist in guiding a user through the injection process. After administering Evzio, emergency medical care should be immediately sought.

“Evzio is the first and only FDA approved naloxone auto-injector specifically designed to be used by individuals without medical training,” said Evan Edwards, kaléo’s vice president of product development. “Additionally, using kaléo’s comprehensive human factors engineering process, Evzio was designed and validated for use by family members and caregivers.”