In hospitals, naloxone injections are administered intravenously to patients in emergencies or after surgery to decrease the effects of opiates given during surgery -- this has been extended to newborns if the mother received opiates prior to delivery. Naloxone belongs to a class of medications called opiate antagonists that block the central nervous system effects of prescription morphine, oxycodone, methadone, fentanyl as well as illegal substances such as heroin. Injection kits and nasal mist formulations have been distributed by some states to caregivers of individuals with a history, though the spray is not FDA-approved and the syringe kits require some needle assembly, Forbes reports.
This new pocket-sized auto-injector -- called Evzio -- can rapidly deliver a single 0.4 mg dose of the drug into the muscle or under the skin when a drug user or patient shows signs of decreased breathing and heart rates, or loss of consciousness. Once turned on, the device gives verbal instructions for the user, and it buys enough time for transportation to a hospital. If those signs and symptoms have nothing to do with opioids, the naloxone injection should have no other effect.
Evzio is manufactured by Virginia-based Kaléo Pharma, and the approval came just four months after the company’s application submission under the FDA’s expedited, fast-tracked review. The agency may be defensive about its records on opioids, New York Times explains:
The FDA has been under pressure since last fall when it approved Zohydro, a new hydrocodone drug, a prescription opioid, against the advice of an expert panel. The drug differs from other painkillers in that it is a pure form of hydrocodone, without acetaminophen, in an extended release form, and the agency contended that it would help patients who needed longer-term treatment for pain and wanted to avoid the risks of liver problems from acetaminophen, the active ingredient in Tylenol.
But health officials who deal with abuse of opioids strongly objected to the approval, saying the drug was an unnecessary addition to the long list of pain drugs on the market.
“Evzio is the first combination drug-device product designed to deliver a dose of naloxone for administration outside of a health care setting,” FDA’s Bob Rappaport says in a news release. “Making this product available could save lives by facilitating earlier use of the drug in emergency situations.”
The product could be available as early as this summer, though Kaléo has not provided a ballpark price.