By Ed Coghlan
The U.S. Food and Drug Administration (FDA) is launching 2016 Naloxone App Competition.
According to the Agency, the competition is a public contest focused on developing innovative technologies to combat the rising epidemic of opioid overdose.
The FDA is inviting computer programmers, public health advocates, clinical researchers, entrepreneurs and innovators from all disciplines to create a mobile phone application that can connect opioid users experiencing an overdose with nearby carriers of the prescription drug naloxone – the antidote for an opioid overdose – thereby increasing the likelihood of timely administration and overdose reversal.
“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.”
The FDA says 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.
The FDA says 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 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.