This competition builds on work announced in the FDA's Opioids Action Plan and the U.S. Department of Health and Human Services' Opioid Initiative (PDF - 350KB) to take concrete steps toward reducing the impact of opioid misuse, dependence and overdose on American families and communities by making naloxone more accessible.
"With a dramatic increase in the number of opioid overdose deaths in the U.S., there's a vital need to harness the power of new technologies to quickly and effectively link individuals experiencing an overdose - or a bystander such as a friend or family member - with someone who carries and can administer the life-saving medication," said FDA Commissioner Robert M. Califf, M.D. "Through this competition, we are tapping public health-focused innovators to help bring technological solutions to a real-world problem that is costing the U.S. thousands of lives each year."
According to SAMHSA, nearly two million Americans abused or were dependent on prescription opioids in 2014. Additionally, overdose deaths involving prescription opioids such as oxycodone, hydrocodone and morphine and illicit opioids, such as heroin and illegally produced fentanyl, have more than tripled since 1999 - with about 28,000 people dying in 2014 alone. Many of these deaths could have been avoided if people experiencing an overdose had immediately received naloxone to stop or reverse the effects of an opioid overdose.
Naloxone is currently only available in the U.S. by prescription, but many states have taken steps to make it more readily accessible to first responders, community-based organizations and laypersons, including friends and family of opioid users. In fact, the number of laypersons provided naloxone nearly tripled between 2010 and 2014, according to the U.S. Centers for Disease Control and Prevention. However, persons carrying naloxone may not be present when an overdose occurs.
"The goal of this competition is to develop a low-cost, scalable, crowd-sourced mobile application that addresses this issue of accessibility," said Peter Lurie, M.D., M.P.H., associate commissioner for public health strategy and analysis at the FDA. "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."
Teams and individuals wishing to participate in the competition will have until Oct. 7, 2016 to register. Registrants will have access to background resources, including information on the opioid epidemic, the approved formulations of naloxone, the public health recommendations for the safe and appropriate use of naloxone and FDA guidance on mobile medical applications. On Oct. 19-20, 2016, the FDA will host a two-day code-a-thon on the FDA campus and virtually for registered entrants to develop their concepts and initial prototypes. All code will be made open-source and publicly accessible, and collaboration will be encouraged. Competition participants will then independently refine their concept and submit a video of a functional prototype along with a brief summary of their concept for the development and use of the app by Nov. 7, 2016.
A panel of judges from the FDA, NIDA, and SAMHSA will evaluate submissions and the highest-scoring entrant will receive an award of $40,000. Following the competition, entrants also may apply for NIDA Small Business Innovation Research (SBIR) grants, subject to eligibility requirements set forth in the SBIR funding opportunity announcement, to further develop their concepts and to develop data to evaluate their real-world impact.
The Naloxone App Competition was developed under the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Reauthorization Act of 2010, which grants all federal agencies broad authority to conduct prize competitions to spur innovation, solve tough problems and advance their core missions.
The highest-scoring entrant will receive an award of $40,000.
Registration opens on Friday, September 23, 2016, and the Competition closes on Monday, November 7, 2016.
For a complete list of challenge rules, to register for the Competition, and to submit a concept, visit www.challenge.gov (the Challenge.gov web page for this challenge will go live when registration opens on Friday, September 23).
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.