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DynamiCare Digital Therapeutic for Smoking Cessation in Pregnant Women Gets Breakthrough Designation
DynamiCare Health, a digital therapeutics and telehealth company, announced this week that its DCH-001, a prescription digital therapeutic designed to treat tobacco use disorder complicating pregnancy and childbirth, has been granted breakthrough device designation by the US Food and Drug Administration. The designation allows DynamiCare Health to now interact with the FDA through an expedited and prioritized process toward marketing the therapeutic.
If given final approval, DCH-001 would become the first prescription treatment for smoking cessation demonstrated to be safe and effective during pregnancy. The intervention is based on a motivational incentives-based approach developed by Stephen T. Higgins, PhD, director of the Vermont Center on Behavior and Health at the University of Vermont. In their first study of the therapeutic, researchers at the university found that pregnant women who were given DCH-001 were 2.8 times more likely to quit smoking by the end of their pregnancy compared to those who used other smoking cessation interventions.
Current clinical guidelines for smoking cessation in pregnancy recommend only behavioral therapies, while FDA-approved medications to treat tobacco addiction in the general population, such as varenicline, bupropion, or nicotine-replacement therapy, have not been demonstrated to be safe for pregnant women.
DCH-001 uses contingency management, combining a smartphone app with a connected breath carbon monoxide detector, saliva-based tests, and a reloadable debit card for financial rewards. Participants are instructed to complete breath and saliva tests through the app while recording themselves on video. An in-person version of the protocol for pregnant individuals developed by University of Vermont researchers resulted in a 68% reduction in low birthweight deliveries.
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