FDA approves auto-injector for opioid overdose

Today the FDA announced the approval of naloxone autoinjection to reverse overdose from opioids. In response to the announcement, FDA commissioner, Margaret A. Hamburg, MD, spoke to the media on prescription opioid abuse prevention.

Hamburg said that for more than 10 years the FDA has been working to address the misuse and abuse of opioid analgesics.

More than 16,000 lives are lost each year due to opioid-related overdoses. Prescription drug overdoses are now the leading cause of injury death in the US, surpassing motor vehicle collisions, according to the press release.

Margaret A. Hamburg

Evzio (naloxone autoinjection, Kaléo Inc.) was granted priority status and reviewed by the FDA in only 15 weeks.

The prescription treatment can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose, according to a press release on the approval.

Evzio is injected into the muscle and under the skin. Once the device turns on, verbal instructions are provided to the user describing how to deliver the medication, like an automated defibrillator, according to the press release.

Hamburg stated that while the long-term goal is to reduce the need for reactionary drugs like these by preventing opioid addiction and abuse, they will be extremely instrumental in saving lives.

“I am confident that [the reduction of opioid abuse and misuse] can be accomplished, but we will all need to work together to invest in strategies and responsible approaches that deter or mitigate the effects of abuse while preserving access to pain medications for patients that need them most,” Hamburg said.