Experts Applaud Rapid FDA Approval of Opioid Overdose Device

Deborah Brauser

April 04, 2014

Representatives from the Substance Abuse and Mental Health Services Administration (SAMHSA) and the National Institute on Drug Abuse (NIDA) are giving high marks to the US Food and Drug Administration (FDA) for its fast-track approval of a handheld autoinjector that reverses opioid overdose.

As reported by Medscape Medical News, the handheld device, which is known as Evzio (naloxone hydrochloride injection, Kaléo, Inc), will allow caregivers to administer a single dose of naloxone to individuals with suspected opioid overdose.

"This product is about preventing deaths," said Douglas Throckmorton, MD, deputy director for regulatory programs at the FDA's Center for Drug Evaluation and Research, during a press briefing.

"Today's FDA approval of Evzio, or naloxone autoinjector, provides an important new tool in our arsenal to more effectively combat the devastating effects of opioid overdose. And it reflects the FDA's commitment to encouraging important new therapies," said Dr. Throckmorton.

Wilson Compton, MD, deputy director at NIDA, noted at the same briefing that the approval is an important milestone event.

"The release of this device…represents an example of using science to address a critical public health need," said Dr. Compton.

Melinda Campopiano, MD, senior medical officer at SAMHSA's Center for Substance Abuse Treatment, agreed. She added that it fits with SAMHSA's "comprehensive approach to our national efforts to prevent overdose fatalities."


Dr. Throckmorton reported that the FDA's review of Evzio was granted priority status. In fact, it was fully reviewed by the organization in just 15 weeks.

"This product is the first autoinjector of naloxone and is designed to rapidly reverse the overdose of either prescription or illicit opioids," he said.

The device is supposed to be stored away until emergency treatment is needed. In the case of a suspected opioid overdose, a family member or caregiver turns on the product and follows the step-by-step instructions for injection that are automatically delivered via an audio recording.

The recording ends with the direction to seek further medical attention for the patient. A video showing this process will soon be available on the pharmaceutical company's Web site.

In addition, Dr. Campopiano noted that SAMSHA has developed "the Opioid Overdose Prevention Toolkit, which is available on the organization's Web site. This free toolkit has been downloaded more than 36,000 times since it was published in August 2013.

"The toolkit provides communities, first responders, patients, overdose survivors and their families, and healthcare providers with information and practical strategies to prevent, recognize, and intervene appropriately in suspected overdoses," she said.

"It also encourages healthcare professionals to prescribe naloxone for patients at risk for opioid overdose for whatever reason. Clearly, this newly approved product will advance that objective."

Possible State Limitations

During the press briefing, there were several questions about how the prescribing of Evzio should work. Dr. Throckmorton explained that it can be prescribed to a substance abuser or even to a child who has been prescribed opioids. Then, in the case of a suspected overdose, it can be administered by family members or caregivers ― even if they are not the ones at risk or listed on the prescription.

Interestingly, the product can also be prescribed directly to the family member or caregiver who is in a setting where there is a risk.

Although Dr. Throckmorton noted that that the FDA's new approval of Evzio should allow the product to be available across the country, there could still be some state-specific limitations regarding the prescribing of naloxone, at least at first. Therefore, clinicians should check with their state's current rules.

"This is an important step towards wider availability and potential reimbursement from insurance, which would have been much harder with makeshift, non-FDA-approved formulations. So this is an important advance," said Dr. Compton.

However, Dr. Campopiano noted that the governor of Maine has publicly said that he does not want these kinds of drugs available to family members because he believes it encourages abuse.

"In a state where there has been resistance to having family and friends have a drug like this, what happens then? I don't think we're going to be able to answer that yet," she said.

Finally, Dr. Throckmorton reported that the FDA is also looking into many other areas, including encouraging the development of medications to reverse the effects of opioids; making treatments for opioid abuse widely available; revising the labeling for opioid medications to foster their safe and appropriate use; improving prescribing practices through education; and using the agency's expedited review program to advance the development of new, nonopioid medications to treat pain.

"Our goal is to bring new, less abusable products to the market. And working with other federal agencies and scientists, we want to advance our understanding of the mechanisms for pain and how to treat it, including the search for nonopioids," he said.


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