Pear’s digital therapeutic for alcohol use disorder gets breakthrough designation
Pear Therapeutics plans to add to its suite of app-based treatments with a new digital therapeutic for alcohol use disorder. Called reSET-A, the app-based program recently got a breakthrough device designation from the Food and Drug Administration.
Alcohol use disorder is estimated to affect 14 million people across the U.S., but less than 10% of people receive any treatment within a year of diagnosis, according to a recent study by researchers at the Washington University School of Medicine. Current treatment options include counseling, medication-assisted treatment to help with cravings or withdrawal effects, and mutual support groups.
The FDA grants a device breakthrough designation if it can provide a new or better treatment for life-threatening or debilitating conditions. Products that get this designation are often prioritized for review, making for a speedier path to the market, although it no longer guarantees Medicare coverage of the device, as the Centers for Medicare and Medicaid Services recently scrapped a coverage rule that was finalized under the previous administration.
Boston-based Pear currently has multiple app-based programs focused on addressing addiction, often in conjunction with other treatments. For example, it has two FDA-cleared therapeutics to address substance use and opioid use disorder, which include modules that patients go through to understand their reasons for use and motivations for sobriety. It also has an FDA-cleared app for insomnia.
Now that it has brought three digital therapeutics to market, Pear is working to garner coverage by health plans. It’s also working on a therapeutic for schizophrenia, which is not yet FDA cleared. Pear was able to open up access to patients thanks to a temporary change where the FDA waived premarket notification requirements for some software-based mental health products.
Separately, Pear is also planning to go public through a merger with a special purpose acquisition company, in a deal that would value Pear at $1.6 billion.
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