The US FDA has recommended a new treatment that acts as an antidote to overdose with an opioid drug, such as heroin or opioid-based painkiller.
Manufactured by kaléo (formerly Intelliject), the treatment is an auto-injection version of naloxone hydrochloride to be marketed under the name Evzio
Naloxone is the current standard treatment for overdose, but existing versions need to be given via syringe and are therefore tend to be limited to use by healthcare professionals in emergency situations.
However, Evzio, which is given via a hand-held auto-injector device, is purposefully intended for use by non-healthcare professionals, such as family members or cares, who are in contact with someone at risk of an opioid overdose.
The FDA compared the device to an automated defibrillator, explaining that it ‘provides verbal instruction to the user describing how to deliver the medication’.
The approval of Evzio comes more than two months ahead of the originally scheduled review completion date of June 20.
This process has been accelerated as the drug was assessed under the FDA’s priority review programme, which speeds up the regulatory process for drugs that appear to provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products.
Evzio also received a ‘fast-track’ status due to the serious nature of its approved indication and the unmet need in treatment.
The need for new ways to address opioid abuse in the US has been heightened in recent years, with drug overdose now the leading cause of injury death in the US – surpassing car accidents. More than 16,000 people from opioid-related overdoses in the US each year.
“Overdose and death resulting from misuse and abuse of both prescription and illicit opioids has become a major public health concern in the US,” said Dr Bob Rappaport, the FDA’s director of the Division of Anesthesia, Analgesia, and Addiction Products.
“Making this product [Evzio] available could save lives by facilitating earlier use of the drug in emergency situations.”
FDA commissioner Margaret Hamburg commented that the device was “an important new tool in our arsenal to more effectively combat the devastating effects of opioid overdose, which is one part of our comprehensive work to support opioid safety”.
She added that a “comprehensive and coordinated approach” from healthcare stakeholders was needed to tackle opioid abuse, including support from the White House, the Department of Health and Human Services and industry.
“I am confident that this 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 medicines for the patients that need them the most,” she concluded.