FDA approves Kaléo's hand-held auto-injector Evzio to reverse opioid overdose

Kaléo announced Thursday that the FDA cleared its hand-held auto-injector Evzio (naloxone) for the emergency treatment of known or suspected opioid overdose. Bob Rappaport, director of the Anesthesia, Analgesia, and Addiction Products division at the FDA's Center for Drug Evaluation and Research, said Evzio "is the first combination drug-device product designed to deliver a dose of naloxone for administration outside of a healthcare setting," adding that it "could save lives by facilitating earlier use of the drug in emergency situations."

The agency noted that results from a 30-patient study showed that a single Evzio injection provided as much naloxone as would be delivered in a single dose with a standard syringe. The device allows users to administer the drug intramuscularly or subcutaneously, and once turned on also provides verbal instructions on how to deliver the medication. The treatment will be available by prescription to patients and their family members or caregivers, but the agency specified that Evzio is not a substitute for immediate medical care. Kaléo said the product, which had been granted priority review as well as fast-track status by the FDA, is expected to be launched this summer.

In July 2012, the FDA unveiled plans to reduce the abuse and misuse of about a dozen extended-release (ER) and long-acting (LA) opioid therapies, and last year disclosed labelling changes and post-market study requirements for all ER and LA opioid analgesics.

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