DynamiCare Health Digital Therapeutic Receives FDA Breakthrough Device Designation for Treatment of Smoking During Pregnancy

BOSTON, Feb. 22, 2022 /PRNewswire-PRWeb/ -- DynamiCare Health Inc., a digital therapeutics and telehealth 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-001, a prescription-only digital therapeutic intended to treat tobacco use disorder complicating pregnancy and childbirth. If approved, DynamiCare's DCH-001 would become the first prescription treatment for smoking cessation demonstrated to be safe and effective during pregnancy. DCH-001 is based on a motivational incentives approach pioneered by Stephen T. Higgins, PhD, of the University of Vermont (UVM). In the first study published on DCH-001, UVM researchers found that pregnant women given DCH-001 were 2.8 times more likely to quit smoking by the end of their pregnancy compared to usual care.

Despite clear evidence of the harms of smoking during pregnancy for both the mother and child, smoking prevalence remains high with 12.8% of mothers smoking during the third trimester. Of the 3.6 million annual births in the U.S., over 460,000 can be expected to be impacted by perinatal smoking. Maternal complications from prenatal smoking include ectopic pregnancies, preeclampsia and placental abruption. Risks to the child include miscarriage/stillbirth, congenital malformations, low birth weight, and potentially lifelong adverse effects on lung and brain development. Furthermore, up to 34% of cases of sudden infant death syndrome (SIDS) are attributable to perinatal smoking.

Although there are FDA-approved medications to treat tobacco use in the general population, such as varenicline (Chantix), bupropion (Zyban), or nicotine-replacement therapy (NRT), these treatments have not been demonstrated to be safe for pregnancy. Current clinical guidelines for smoking in pregnancy recommend only behavioral therapies.

Like other DynamiCare products, DCH-001 utilizes a therapeutic methodology called contingency management, in which patients earn financial incentives for achieving abstinence from addictive substances. DCH-001 combines a smartphone app with a connected breath carbon monoxide monitor, saliva cotinine (nicotine) tests, and a reloadable debit card. Participants complete breath and saliva tests through the app over selfie video. If they test negative, they earn financial rewards on the debit card. The approach was developed by UVM researchers, who found that an in-person version of this protocol for smoking cessation in pregnancy resulted in a 68% reduction in low birthweight deliveries. The approach is also highly cost-effective, with an estimated $48 in benefits to society for every dollar spent on contingency management for smoking cessation in pregnancy.

"Smoking is one of the hardest addictions to break, and the correlations with social determinants of health mean that pregnant smokers are struggling with many other challenges in their lives as they try to quit, without the help of medications that are available to everyone else," said Eric Gastfriend, CEO of DynamiCare Health. "Our mission is to support expecting mothers in quitting to improve outcomes for them and their babies. DynamiCare's digital therapeutic could become the first treatment for smoking demonstrated to be safe and effective during pregnancy, and we are honored that FDA has recognized DCH-001 as a breakthrough device."

"We know that contingency management works," said Stephen T. Higgins, PhD, Director of UVM's Vermont Center on Behavior and Health and the leading expert on contingency management for smoking cessation in pregnancy. The FDA Breakthrough Designation is based upon UVM's research and findings on DCH-001. "This methodology has been known for over 30 years to be one of the most clinically effective and cost-effective approaches for substance use disorders. There are babies being born every day with health problems that could be prevented through this approach."

The FDA Breakthrough Device 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-001.

For more information: https://www.dynamicarehealth.com/our-results

DynamiCare Health
DynamiCare Health is a digital therapeutics and telehealth 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, tobacco, and vaping. For more information, visit http://www.dynamicarehealth.com.

The Vermont Center on Behavior and Health at UVM
The Vermont Center on Behavior and Health (VCBH) at the University of Vermont, Larner College of Medicine is led by Director Stephen T. Higgins, PhD. An interdisciplinary research center, it investigates relationships between personal behavior patterns (i.e., lifestyle) and risk for chronic disease and premature death. Its work has historically focused on health disparities for the most vulnerable populations, particularly the socioeconomically disadvantaged. VCBH researchers focus on understanding mechanisms of risk and developing interventions and policies to promote healthy behavior, through behavioral economics and behavioral pharmacology.

REFERENCES

CDC - Centers for Disease Control. (2018, November 13). CDC - PRAMS and Smoking—Pregnancy Risk Assessment Monitoring System—Reproductive Health. https://www.cdc.gov/prams/tobbacco.html

Kurti AN, Tang K, Bolivar HA, Evemy C, Medina N, Skelly J, Nighbor T, Higgins ST. Smartphone-based financial incentives to promote smoking cessation during pregnancy: A pilot study. Preventive Medicine. Published online July 2020:106201. doi:10.1016/j.ypmed.2020.106201

American College of Obstetricians and Gynecologists (ACOG). (2020). Tobacco and Nicotine Cessation During Pregnancy. Obstetrics and Gynecology, 135(5), e221–e229.

Higgins, S. T., Bernstein, I. M., Washio, Y., Heil, S. H., Badger, G. J., Skelly, J. M., Higgins, T. M., & Solomon, L. J. (2010). Effects of Smoking Cessation with Voucher-Based Contingency Management on Birth Outcomes. Addiction (Abingdon, England), 105(11), 2023–2030. https://doi.org/10.1111/j.1360-0443.2010.03073.x

WSIPP (Washington State Institute for Public Policy). Smoking cessation programs for pregnant women: Contingency management. Benefit-Cost Analysis. Published December 2019. Accessed December 3, 2021. http://www.wsipp.wa.gov/BenefitCost/Program/709

Media Contact

Thy-Ann Nguyen, DynamiCare Health, 1 703-479-3642, [email protected]

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