The dilemma is this: Despite the FDA’s desperate efforts to fast-track the approval of an easily administered, lifesaving form of an opioid overdose antidote called naloxone, the drug still requires a prescription in some states. Without immediate access in the critical moments of an overdose, as a person’s breathing grows more shallow and level of consciousness fades, the antidote is useless.
Some states have tried to eliminate this barrier by making naloxone — and a nasal-spray version of the antidote sold under the brand name Narcan — more readily available to first responders, community organizations and even the friends and family members of opioid users, and some states have made the antidote available without a prescription — all in an effort to create a grass-roots web of people willing and able to help.
Now, the FDA wants to take that concept one step further — by building an app.
It will be like Yelp, but for the nearest naloxone instead of takeout Chinese.
In an announcement Monday, officials called on coders across the country to submit entries to the 2016 Naloxone App Competition, a program developed under the America COMPETES (Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science) Reauthorization Act of 2010, which funds prize contests created by federal agencies to spark innovation.
Registration opens Sept. 23 and closes Oct. 7. The FDA will host a two-day code-a-thon virtually and on its campus Oct. 19-20, where participants will develop early concepts. All code will be made open-source, according to a news release, and “collaboration will be encouraged.”
The ideas will then be independently refined and resubmitted with a prototype video and conceptual description by Nov. 7. A panel of judges from the FDA, National Institute on Drug Abuse (NIDA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) will review the submissions.
The highest-scoring proposal will be awarded $40,000.
“The goal of this competition is to develop a low-cost, scalable, crowd-sourced mobile application that addresses this issue of accessibility,” Peter Lurie, associate FDA commissioner, said in the news release. “Mobile phone applications have been developed to educate laypersons on how to recognize an overdose and administer naloxone, and to connect bystanders with individuals in need of other medical services, such as CPR. To date, however, no application is available to connect carriers of naloxone with nearby opioid overdose victims.”
Lurie told the Los Angeles Times that ideally, the app could connect people in neighborhoods or even large apartment buildings. A first responder could use a naloxone finder on her cellphone to pinpoint a dose in a medicine cabinet down the hall.
This time last year, the only way naloxone could be administered legally was by injection. The FDA fast-tracked the review of a nasal spray form of the antidote, called Narcan, which first responders were more easily able to deliver as opioid overdoses rapidly rose across the country. It was approved in November.
Since then, drugstores — including CVS and Walgreens — have announced plans to sell naloxone and Narcan without a prescription in states where that is legal. In February, Walgreens revealed plans to roll out the antidote in 35 states and the District of Columbia without a prescription by the end of the year. That same month, CVS announced it would expand its sales to a total of 35 states as well, reported CNN.
Phil Skolnick from the NIDA explained in a video interview that Narcan is so effective because the antidote does not need to hit the lungs to begin reversing the overdose. The medication is absorbed through the nasal cavity and into the bloodstream, working almost immediately.
“You can actually resurrect someone,” Skolnick said.
About 28,000 people died in 2014 from opioid overdoses, both from prescription opioids like oxycodone, hydrocodone and morphine, and illicit ones like heroin and fentanyl. Since 1999, overdose deaths have more than tripled.
This summer, health and law enforcement officials have been overwhelmed by staggering numbers of heroin overdoses in cities across the country, made worse by the dangerous new opioids with which it’s being cut. First it was fentanyl, a synthetic opioid similar to morphine but as much as 100 times more potent. Then officials started finding fentanyl’s much stronger cousin, carfentanil, which is 100 times more potent than fentanyl and 10,000 stronger than morphine.
It’s primarily used as a large-animal tranquilizer. It’s strong enough to knock out an elephant.
Disturbingly, the potency of heroin laced with fentanyl or carfentanil means that the usual doses of naloxone aren’t always effective on overdose patients, forcing first responders to administer multiple doses of the antidote to get the same results and depleting supplies along the way.
In a media conference call with reporters, Lurie acknowledged the app idea does not come without challenges, particularly legal ones because the drug can only be obtained through a prescription in some places. He said legal changes, like the “good Samaritan” laws already in place in many states, could absolve a naloxone provider of liability if the rescue attempt is unsuccessful.
Ultimately, he said, these are small hurdles compared to size of the opioid problem nationwide.
“There’s not a minute to waste,” Lurie told the Times.