FDA Okays Handheld Device that Reverses Painkiller Overdose

The U.S Food and Drug Administration announced Thursday that it has approved a new emergency tool called Evzio (naloxone hydrochloride injection) for use in people with suspected or known opioid overdose.

 The medical device okayed for emergency opioid treatment is similar to EpiPen, which is used to treat allergies. The easy-to-use auto injector delivers a specific amount of the drug to the patient. The device is small enough to be carried in a pocket or stored in a medical cabinet.

The handheld injector can be used by family or caregivers for treatment of suspected or known cases of opioid overdose. Most of these overdoses occur in people who are dependent on painkillers. Symptoms of painkiller overdose include loss of consciousness, elevated heart rate or shallow breathing.

Around 16,000 people die due to opioid-related overdoses, according to a statement by Margaret A. Hamburg, Commissioner, FDA. In fact, number of deaths due to drug overdose is higher than deaths in motor vehicle accidents in the United States.

Naloxone is a standard treatment for opioid overdose. It reverses the symptoms of the drug overdose.  Currently, the drug is only given via injections by trained medical professionals.

The efficacy of the new drug delivery system was tested on 30 patients. FDA said that the amount of drug injected by the device was similar to the amount administered by a regular injection.

"Evzio is the first combination drug-device product designed to deliver a dose of naloxone for administration outside of a health care setting. Making this product available could save lives by facilitating earlier use of the drug in emergency situations," said Bob Rappaport, at the FDA's Center for Drug Evaluation and Research, according to a news release.

The newly approved drug is injected intramuscularly (muscle) or subcutaneously (under the skin). The device gives verbal instructions to the users on how to administer the drug. According to FDA, family members or caregivers must be familiar with the instructions before treating a person with suspected drug overdose.

The agency also warned that the use of Evzio might lead to severe opioid withdrawal in patients. Nausea, vomiting, high blood pressure and cardiac arrest might follow opioid withdrawal.