The FDA has okayed anauto-injector formulation of naloxone (Evzio), intended to expand the use of an agent that can rapidly reverse an opioid overdose. In a call with stakeholders Thursday, Health and Human Services Secretary Kathleen Sebelius called the auto-injector a "more user-friendly version" of naloxone, which is only currently available in syringe form, although an off-label nasal version has been used in first-responder programs in several cities.
Anyone at risk for overdose can obtain a prescription for the drug, as can family members or caregivers of those at risk, Douglas Throckmorton, MD, deputy directory for regulatory programs at the FDA's Center for Drug Evaluation and Research, said during a separate telephone briefing with reporters.
The device itself gives verbal instructions on how to use it, similar to instructions relayed by automated external defibrillators found in public facilities, FDA Commissioner Margaret Hamburg, MD, said during that call.
Officials emphasized that the final direction is to seek medical care: "We don't want people to have the sense that this is the last thing they need to do," Throckmorton said. "They need to get help."
Since many prescription opioids on the market are long-acting drugs, the naloxone may not work as long as those opioids, so repeat doses may be needed, the agency said.