FDA: Develop Crowd-Sourced Mobile App to Promote Naloxone Use

In order to combat the drastic increase in deaths due to opioid overdose, the US Food and Drug Administration is holding the 2016 Naloxone App Competition, a public contest in which entrepreneurs and innovators, from programmers to clinical researchers are invited to develop a cell phone app that would connect opioid users experiencing an overdose to nearby carriers of naloxone.¹

“With a dramatic increase in the number of opioid overdose deaths in the US, there is a vital need to harness the power of new technologies to quickly and effectively link individuals experiencing an overdose […] with someone who carries and can administer the life-saving medication,” said FDA Commissioner Robert M. Califf, MD, in a statement.

“Through this competition, we are tapping public health-focused innovators to help bring technological solutions to a real-world problem that is costing the US thousands of lives each year,” he added.

Working To Reduce Opioid Overdose

The competition, which has the support of the National Institute on Drug Abuse (NIDA) and Substance Abuse and Mental Health Services Administration (SAMHSA), builds on the work laid out in the FDA Opioids Action Plan.² The action plan includes:

• Consulting expert advisory committees before approving new drug applications for opioids that do not have abuse-deterrent properties
• Improving safety labeling on immediate-release opioid medication
• Requiring long-term studies from pharmaceutical companies to measure the impact of extended-release and long-acting opioids
• Updating the Risk Evaluation and Mitigation Strategy Program to broaden prescriber access to safe opioid prescribing training
• Expanding access to and development of abuse-deterrent formulations

Accessibility to Naloxone

The competition also builds on the US Department of Health and Human Services’ Opioid Initiative, which lays out plans to increase access to naloxone.³ Deaths from synthetic opioids-including fentanyl- skyrocketed, increasing by 80% from 2013 to 2014, calling for an urgency to expand access to naloxone .

SAMHSA was awarded a $12 million grant, as part of the President’s Budget request for 2017 to “prevent prescription drug/opioid-overdose-related deaths,” which will provide naloxone to first responders and educate them on its use and administration.

In addition, $10 million were granted to the Health Resources and Services Administration’s Rural Opioid Overdose Reversal Grant Program, with a similar goal as the SAMHSA grant, but for rural communities.

While acquiring naloxone in the United States currently requires a prescription, the drug is accessible to healthcare providers, first responders, community organizations and those close to opioid users in a number of states. According to the US Centers for Disease Control and Prevention, naloxone access to non-healthcare providers increased nearly 3-fold between 2010 and 2014.¹

Contest Information

This app contest follows a series of similar funding opportunities that focus on developing technologies to address the opioid epidemic; NIDA and the Appalachian Regional Commission announced in February 2016 an opportunity for 1-year research grants “to address a dramatic increase in adverse outcomes associated with increased opioid injection drug use in Appalachia.”⁴

Other recent contests that specifically focused on app development include NIDA’s “Addiction Research: There’s an App for that” contest, which concluded in August 2016, and focused on developing mobile apps for future addiction research.⁵ Winners included Track the Crave, Substance Abuse Research Assistant, which was developed by a group of undergraduates at the University of Michigan, and Genomics of Addiction.

The competition can be followed on social media with the hashtag #NaloxoneApp.

References

1. FDA launches competition to spur innovative technologies to help reduce opioid overdose deaths. Food and Drug Administration. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm520945.htm. Accessed September 29, 2016.
2. Fact Sheet — FDA Opioids Action Plan. Food and Drug Administration. Available at: http://www.fda.gov/NewsEvents/Newsroom/FactSheets/ucm484714.htm. Accessed October 3, 2016.
3. The Opioid Epidemic: By the Numbers. Department of Health and Human Services. Available at: http://www.hhs.gov/sites/default/files/Factsheet-opioids-061516.pdf. Accessed September 29, 2016.
4. NIDA and ARC announce funding opportunity for research projects to address opioid injection use and its consequences in the Appalachian Region. National Institue on Drug Abuse. https://www.drugabuse.gov/news-events/news-releases/2016/02/nida-arc-announce-funding-opportunity-research-projects-to-address-opioid-injection-use-its. Accessed October 3, 2016.

 

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This article originally appeared on Clinical Pain Advisor