Easy-to-Use Overdose Antidote Earns Fast-Track Approval

To help lay people administer naloxone if they witness an opioid drug overdose, Evzio gives step-by-step audio instructions. Image: @2014 Kaleo

To help lay people administer naloxone if they witness an opioid drug overdose, Evzio gives step-by-step audio instructions. Image: @2014 Kaleo

An easy-to-use opioid overdose antidote for outpatients has earned a speedy approval from the US Food and Drug Administration (FDA). Physicians may prescribe the drug to someone taking opioids or to other members of the household who may be at risk, such as a child who might ingest a parent’s medication, according to FDA spokeswoman Sandy Walsh.

The product, called Evzio, is an autoinjectable device containing a single dose of naloxone.

Naloxone has long been a staple in emergency departments, where it is used to reverse the effects of an overdose on an illicit or prescription opioid. It is also used to reverse the effects of anesthesia. But local and national organizations have worked to make the drug more widely available in the community to combat an ongoing epidemic of opioid overdoses. According to the FDA, there were 16 000 deaths from overdose of prescription opioids in 2010, and 3000 heroin overdoses.

An opioid antagonist, naloxone works by outcompeting other opioid drugs in binding to brain receptors. Within minutes, it reverses respiratory depression and prevents death.

Because many overdoses occur outside of hospitals, some states have taken steps to equip police and other first responders with the drug. Some community groups supply the drug to loved ones of individuals at risk of an overdose. The Substance Abuse and Mental Health Services Administration (SAMHSA) recently issued an opioid prevention tool kit that advises physicians to prescribe naloxone alongside opioids in case of an overdose by the patient or someone else in the household.

Evzio is the first FDA-approved product designed for use by nonclinicians. When activated, the autoinjectible Evzio provides step-by-step instructions for use. At press time its price had not been set. . However, some community-based overdose prevention organizations have created naloxone kits that cost about $50 and have a nasal applicator or contain prefilled syringes to make administration easier.

Melinda Campopiano, MD, senior medical officer at SAMHSA’s Center for Substance Abuse Treatment, explained that many physicians have been reluctant to prescribe vials of naloxone for injection or unapproved nasal administrators.

“This device is an exciting innovation and will hopefully result in more naloxone being in the hands of people who need it,” she said.

Douglas Throckmorton, MD, deputy director for regulatory programs at the FDA’s Center for Drug Evaluation and Research, said the approval, which was processed in just 15 weeks, is the latest FDA effort to help curb the ongoing epidemic of prescription drug overdose. Administering naloxone to individuals who have taken other types of drugs will have no effect, he noted.

The SAMHSA overdose prevention tool kit has information for prescribers, patients, and others. Additional information for prescribers including state-level information is available online. The California Society of Addiction Medicine also has naloxone prescribing resources, including videos.

Campopiano said physicians who wish to prescribe may want to work with a local pharmacy and their patient’s insurer to ensure access. Most formularies include naloxone, but insurers and pharmacies are still trying to catch up with growing outpatient use, she noted.

Categories: Pain, Public Health, Substance Abuse/Alcoholism

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