AUD Therapy Wins FDA's Breakthrough Device Designation

AUD Therapy Wins FDA's Breakthrough Device Designation unknown

A prescription digital therapeutic aimed at treating alcohol use disorder (AUD) has been granted breakthrough device designation by FDA.

The decision regarding DynamiCare Health Inc.’s DCH-002 therapeutic suggests the regulatory agency believes the therapy has the potential to provide substantial improvement in patient care compared to existing therapies. It also marks a major milestone for the company, which has focused its pipeline on products targeting AUD, opioid use disorder, and smoking and vaping cessation.

DynamiCare said about 29 million Americans are believed to have AUD, but 90% of those patients do not receive any treatment for the condition. Of those who do receive treatment, 73% stop therapy within five months.

Eric Gastfriend, MBA, the company’s co-founder and CEO, told Managed Healthcare Executive, that a digital therapeutic is a good fit for AUD in part because many people with the disorder are hesitant to take medications.

“Medications are also contraindicated for many subgroups (people who are pregnant, for example),” he noted. “Digital therapeutics are free of side-effects and highly accessible and engaging for patients.”

DCH-002 uses a combination of strategies to engage patients. Like many other digital therapeutics, the intervention includes cognitive behavioral therapy (CBT) modules to help patients learn skills to deal with stress, triggers, and cravings. However, it also leverages a methodology called “contingency management” (CM), in which patients receive a financial incentive to abstain from alcohol. Patients are given a Bluetooth-connected breathalyzer that works in combination with the DCH-002 smartphone app. The app prompts users to take random breath tests to measure their blood alcohol content. The app also uses the smartphone’s camera feature to ensure the patient — and not someone else — is using the breathalyzer. If the patient tests negative for alcohol, they receive monetary rewards. Those funds are deposited on a special debit card that blocks transactions at bars and liquor stores, and also blocks cash withdrawals.

Gastfriend said the combination of CBT with CM works better than either intervention would work individually.

“This is because CM drives early abstinence and boosts engagement and retention in treatment, while CBT teaches skills for long-term recovery,” he said.

He added that research from the Washington State Institute for Public Policy found CBT and incentives were the two treatment strategies with the highest return on investment for people with substance use disorders.

The FDA’s breakthrough designation could also have major business implications for Gastfriend’s company.

“That helps us gain credibility among payers and providers as a clinically rigorous program with strong evidence,” he said.

He noted that a bill introduced last month in Congress would require that the Centers for Medicare and Medicaid Services (CMS) automatically provide coverage for breakthrough devices for the first four years for patients with Medicare. During that time, the agency could evaluate the device and make a permanent decision on whether to continue coverage following five years. The bill’s sponsors say the legislation would remove unnecessary barriers to access to innovative therapies.

“[I]f that bill or something similar passes, having breakthrough status will be enormously helpful with commercialization,” Gastfriend said.

In the meantime, the company is currently in the process of conducting a 12-month, multisite randomized controlled trial of DCH-002, hoping to generate additional data to show the efficacy of its approach.