Better Therapeutics, Inc. announced that the Food and Drug Administration (FDA) authorized AspyreRxâ„¢? (formerly BT-001), a prescription-only digital therapeutic (PDT) treatment indicated to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes (T2D). AspyreRx was reviewed through the FDA's De Novo pathway and its authorization creates a new class of diabetes digital behavioral therapeutic devices.

AspyreRx is expected to launch commercially in Fourth Quarter 2023. AspyreRx was granted marketing authorization based on efficacy and safety data from a randomized controlled trial involving 668 participants, demonstrating clinically meaningful results, which were published in Diabetes Care. Summary of Clinical Trial Results: The trial met its primary (p; 1 in 2 people achieved a mean A1c reduction of 1.3% after 180 days of use.