Food and Drug Administration to Hold Contest to Develop Technologies Reducing Overdose Deaths
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Food and Drug Administration to Hold Contest to Develop Technologies Reducing Overdose Deaths

Programmers, health advocates, clinical researchers, entrepreneurs, and innovators can participate

September 20, 2016

The Food and Drug Administration (FDA) has announced the 2016 Naloxone App Competition, a contest for the public to develop innovative technologies to fight the growing epidemic of opioid overdosing.

Together with the National Institute on Drug Abuse (NIDA) and the Substance Abuse and Mental Health Services Administration (SAMHSA), the agency invites all computer programmers, public health advocates, clinical researchers, entrepreneurs, and innovators to design and develop a mobile app to connect opioid users who have overdosed to nearby carriers of the antidote, prescription drug naloxone. Such a connection will increase the probability of prompt administration of the antidote and therefore of reversal of the overdose.

The contest builds on work that was announced in the FDA's Opioids Action Plan and the Department of Health and Human Services's Opioid Initiative in taking tangible, concrete action to reduce the damaged caused by opioid misuse, dependence and overdose by making the antidote more accessible.

The Opioid Epidemic

"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."

SAMSHA estimates that almost two million Americans either abused or were dependent on prescription opioid medications in 2014. Deaths from overdoses involving such medications as oxycodone, hydrocodone, and morphine, as well as illegal opioids such as heroin and illegally-manufactured fentanyl, have more than tripled since 1999. In 2014, roughly 28,000 people died. Many of these deaths could have been prevented with the prompt application of naloxone.

Although the antidote is available in the U.S. only by prescription right now, numerous states are working on increasing accessibility for first responders, community-based organizations, and laypeople such as the friends and family of anyone using an opioid. According to the Centers for Disease Control and Prevention, the number of such laypeople who were provided with naloxone almost tripled between 2010 and 2014.

The Contest

"The goal of this competition is to develop a low-cost, scalable, crowd-sourced mobile application that addresses this issue of accessibility," said FDA Associate Commissioner for Public Health Strategy and Analysis Peter Lurie, M.D., M.P.H.

"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."

October 7, 2016 is the deadline for teams and individuals to register for the contest. Background resources, such as information on the opioid epidemic, approved naloxone formulations, public health recommendations for safe and appropriate use of the antidote, and FDA guidance on mobile apps in the medical field, will be available to registrants.

The agency will host a code-a-thon on October 19-20, 2016 on its campus as well as virtually for all registered contest entrants to develop their concepts and their initial app prototypes. All code for the contest will be made open source and accessible to the public, and collaboration will be encouraged. Participants will then refine their apps independently and will have until November 7, 2016 to submit a video of a working prototype and a short summary of their ideas for the app's development and use.

Submissions will be evaluated by a panel comprising judges from the FDA, NIDA, and SAMHSA, and the prize for the highest-scoring entrant will be a $40,000 award. After the contest, entrants will be able to apply for NIDA Small Business Innovation Research (SBIR) grants, subject to requirements for eligibility to be provided in the SBIR funding opportunity announcement, to continue developing their ideas as well as gathering data to evaluate the real-world impact they make.

Consumers can follow the contest on social media by using #NaloxoneApp.