The Second Chance app from University of Washington investigators is seeking FDA consideration in the near future.
Photo courtesy of the University of Washington
The first device designed to monitor and connect overdosing patients with emergency medical services (EMS) is being prepped for US Food and Drug Administration (FDA) consideration.
The Second Chance mobile app, a brainchild of investigators at the University of Washington (UW), would use sonar monitoring to detect opioid overdoses through user’s breathing rates. In data published on Wednesday, the team—co-led by Jacob Sunshine, MD, assistant professor of anesthesiology and pain medicine at the UW School of Medicine—reported the app can accurately predict overdose-related symptoms approximately 90% of the time.
Real-world research into the app’s algorithm and design was co-hosted by supervised injection facility Insite, in Vancouver, BC. Participants wore monitors on their chest to track breathing rates, then were asked to prepare their own injection drugs. During their preparation, investigators monitoring their breathing rate for a baseline value. Following injection and the 5 minutes afterward, they were monitored for overdose symptoms.
Among the 94 participants tested, 47 (50%) reported a breathing rate of 7 breaths per minute or less, 49 (52.1%) stopped breathing for a significant period of time, and 2 (2.1%) experienced an overdose event that required oxygen, ventilation, or naloxone treatment.
The app is also capable of tracking a person’s breathing from up to 3 feet away, meaning overdosing people may not need to have their phone on their person during an event to receive help.
Sunshine said the app uses 2 precursors to assess overdoses: a person’s stopped breathing, and their breathing rate dropping to 7 breaths per minute or less. He explained to MD Magazine® that legislative and clinical responses to overdoses due to the opioid epidemic have improved how patients are identified and how they are treated.
What’s been lacking is aide between these 2 events: when overdoses occur in identified at-risk persons, in unmonitored places.
“The big challenge with the opioid epidemic is people experiencing overdoses in unwitnessed environments, leading them to die,” Sunshine said. “We know how to identify the problem and how to treat it, but the problem has been connecting those 2 in a timely fashion.”
Sunshine pointed to the FDA’s advisory panel voting in favor last month to recommend a co-prescription of naloxone with opioids on the latter therapy’s labels. The decision was intended to at least incite dialogue between physicians and patients about the addictive and overdosing risks associated with painkiller medicine.
In Sunshine’s vision, the Second Chance app would serve as a second co-prescription with opioids.
“This technology applies to any of those people prescribed opioids, or any of their friends or family members,” he said.
Sunshine noted the effects of the opioid epidemic on his own region of Washington state is similar to that seen throughout the country: a mixture of addiction patients mixing drugs with fentanyl for a high, as well as chronic pain patients succumbing to the additive effects of their prescribed therapy. His team’s app would service these 2 groups slightly differently.
“For the former group, want to add functionality that connects patients with medication-assisted therapy, naloxone, counseling, additional help,” he said. “For those who may not have a primary care physician, we want to have a way that connects them to health services. This could be something of interest for extremely at-risk populations, including pregnant women with opioid use disorder (OUD).”
Care providers would be able to refer patients with OUD or a prescription to opioid pain therapy to the app, in the event of an overdose—regardless of the patients’ intent of drug use. Sunshine noted its common for patients with chronic pain taking a prescribed rate of opioid therapy accidentally triggering overdose symptoms when adding sleep therapy to their regimen.
The team is currently in the process of compiling its application for an FDA 510(k) clearance, and Sunshine added their efforts are ensuring the technology is “rigorously evaluated” prior to vying for marketing.