Digital therapeutics company, DynamiCare Health Inc., has received U.S Food and Drug Administration (FDA) Breakthrough Device Designation for its prescription-only digital therapeutics for the treatment of alcohol use disorder (AUD).
The product DCH-002 utilises a therapy method called contingency management, in which users earn financial rewards for abstinence from addictive substances. DCH-002 combines a smart phone app, bluetooth-connected breathalyser, and a smart debit card. In order to earn financial rewards, users must test negative after completing randomised breath testing using the breathalyser and verified through self recorded video. DCH-002 also includes self-guided therapy modules based on cognitive behavioural therapy (CBT) teaching skills such as management of stress, triggers, and cravings.
The Breakthrough application was based on a randomised controlled trial, which demonstrated that patients using DCH-002 as an outpatient treatment were eight times more likely to remain in treatment past 90 days and had verified abstinence rates twice as high as controls.
“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.
Receiving Breakthrough Device Designation will allow DynamiCare Health to interact with the FDA through an expedited and prioritised process towards the marketing of DCH-002.
DynamiCare Health previously received Breakthrough Device Designation for DCH-001, a prescription digital therapeutic intended to treat tobacco use disorder complicating pregnancy and childbirth.
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