DynamiCare Health Digital Therapeutic Receives FDA Breakthrough Device Designation for Treatment of Alcohol Use Disorder
DynamiCare Health announced today that the FDA has granted Breakthrough Device Designation for its prescription-only digital therapeutic intended to treat alcohol use disorder (AUD).
BOSTON, March 28, 2023 /PRNewswire-PRWeb/ -- DynamiCare Health Inc., a digital therapeutics company dedicated to helping people overcome addiction, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for DCH-002, a prescription-only digital therapeutic intended to treat alcohol use disorder (AUD).
The Breakthrough application was based on a randomized control trial funded by the National Institutes of Health and published by an external team of researchers from Johns Hopkins University School of Medicine. The study demonstrated that patients randomized to receive DCH-002 as part of outpatient AUD treatment were 8 times more likely to remain in treatment past 90 days and had verified abstinence rates twice as high as controls.
Over 29 million Americans suffer from AUD. Every year – even accounting for exponential increases in drug poisoning deaths – more Americans die from AUD-related complications than drug overdoses. There is a major gap in care: 90% of people with AUD do not receive any treatment. Even among those who do seek and receive treatment, attrition is alarmingly high – 73% of patients drop out by month five. DCH-002 offers an evidence-based technology solution designed to help adults living with AUD to reduce or cease their consumption of alcohol and dramatically improve outcomes and retention in treatment.
There are FDA-approved medications to treat AUD, such as naltrexone (Revia and Vivitrol), disulfiram (Antabuse), and acamprosate. These medications, however, are utilized by only 22% of individuals in treatment for AUD. DCH-002 is designed to increase access to care by offering patients a highly effective intervention with the convenience and privacy of remote care and without side effects or contraindications (e.g., pregnancy or liver disease). As a digital therapeutic, DCH-002 is expected to have a low risk profile and can be used in conjunction with medication or other psychosocial treatments, when cleared by the FDA for marketing.
Like other DynamiCare products, DCH-002 implements a long-established therapeutic methodology called contingency management, in which patients earn financial incentives for achieving abstinence from addictive substances. DCH-002 combines a smartphone app with a Bluetooth-connected, police-grade breathalyzer, and a reloadable, risk-protective smart debit card. Participants complete random breath tests to measure Blood Alcohol Content (BAC) through the app, validated over selfie video. If they test negative, they earn financial rewards on the smart debit card, which blocks access to bars, liquor stores, and cash withdrawals. DCH-002 also includes a library of self-guided therapy modules based on cognitive behavioral therapy (CBT), teaching skills such as how to deal with stress, triggers, and cravings.
"We know that contingency management helps in the treatment of alcohol use disorder," said Laura E. Kwako, PhD, Chief of the Treatment, Health Services, and Recovery Branch at the National Institute on Alcohol Abuse and Alcoholism (NIAAA), part of the National Institutes of Health (NIH). The DynamiCare FDA Breakthrough Designation is based upon research funded by a Small Business Innovation Research grant from NIAAA.
"I'm proud to support DynamiCare because their platform is advancing evidence-based treatments that the field desperately needs," said former U.S. Rep. Patrick J. Kennedy, a DynamiCare Health investor and advisor.
"It's clear the field of alcohol use disorder treatment is in need of new solutions when only 10% of people with the condition seek and receive treatment, and only a quarter of those stay engaged past 5 months," said Eric Gastfriend, CEO of DynamiCare Health. "Our mission is to automate best practices so that addiction treatment becomes more accessible, engaging, and effective. Our product could become the first FDA-approved digital therapeutic for alcohol use disorder, and we are honored that FDA has recognized DCH-002 as a medical breakthrough."
DynamiCare has received a$1.6M grant from NIAAA to conduct a multi-site, 12-month randomized controlled trial of DCH-002, which is currently underway.
The FDA Breakthrough Devices Program is intended for devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Breakthrough designation will now allow DynamiCare Health to interact with the FDA through an expedited and prioritized process towards the marketing of DCH-002.
This is the second FDA Breakthrough Device Designation for DynamiCare. The company previously received the designation for DCH-001, its technology for treatment of smoking cessation in pregnancy.
For more information: https://www.dynamicarehealth.com/our-results
About DynamiCare Health
DynamiCare Health is a digital therapeutics company dedicated to helping people overcome addiction. The company's digital health platform automates contingency management, an evidence-based system for rewarding healthy behavior that has been demonstrated to be effective in over 100 randomized controlled trials. Through encouragement and accountability, DynamiCare members achieve healthy goals with stimulants, opioids, alcohol, and tobacco. For more information, visit http://www.dynamicarehealth.com.
Research reported in this publication was supported by the National Institute on Alcohol Abuse and Alcoholism of the National Institutes of Health under Award Number R43AA026234. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
REFERENCES
Hammond A, Sweeney MM, Chikosi TU, Stitzer ML. Digital delivery of a contingency management intervention for substance use disorder: A feasibility study with DynamiCare Health. Journal of Substance Abuse Treatment. 2021. doi:10.1016/j.jsat.2021.108425
Media Contact
Eric Gastfriend, DynamiCare Health, 1 6175641084, [email protected]
SOURCE DynamiCare Health
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