Can a software application be used treat alcohol use disorders? The medical technology company Pear Therapeutics is leading the way in showing that digital therapeutics are effective in treating substance use disorders. Early this week, the company announced that it received Breakthrough Device Designation from the United States Food and Drug Administration (FDA) for its prescription digital therapeutic called reSET-A. The Breakthrough Device Designation allows the company to work closely with the FDA to more quickly and efficiently receive full approval for their product.
The reSET-A therapeutic is a software-based disease treatment that is designed to directly treat alcohol use disorder. Alcohol use disorder is a common substance abuse disorder that is characterized by inability to control alcohol use despite severe social, occupational, and health consequences. Alcohol use disorder is common in the United States and affects nearly 14.1 million adults aged 18 and older.
While treatments exist for alcohol use disorder, only about 1 in 10 individuals with the disease seek treatment. However, Pear Therapeutics hopes that their software will reach many individuals with the disorder to effectively treat it. Pear Therapeutic’s Chief Medical Officer, Yuri Maricich, said, “we believe [prescription digital therapeutics] can bring effective, evidence-based treatments for alcohol use disorder (AUD) to many more people, and in doing so help address the public health burden of AUD.”
The software works by supplying the patient with cognitive behavioral therapy via a phone-based application. The software also includes an associated dashboard for the prescribing clinician that displays information about the patients’ use of the reSET-A. The digital therapeutic is meant to be used in conjunction with other pharmacological treatments.
This is the third prescription digital therapeutic product in Pear Therapeutic’s portfolio. The other two, reSET-O and reSET, are used to treat opioid abuse and substance abuse disorder, respectively. These programs have been evaluated in clinical research studies and have shown that these prescription digital therapeutics improve patient outcomes and save money. One study found that reSET-O was associated with fewer inpatient and emergency department encounters. Additionally, another study found reSET-O was a cost-effective treatment that helped increase sobriety adherence. Pear Therapeutics hopes to gain full FDA approval for reSET-A within the next year.
Sources: Pear Therapeutics; National Institute on Alcohol Abuse and Alcoholism; Pear Therapeutics; Expert Review of Pharmacoeconomics and Outcomes Research; Journal of Medical Economics