AspyreRx became the first cognitive behavioral therapy (CBT) to receive FDA authorization for treating type 2 diabetes in July. The prescription digital therapeutic (PDT) underwent review through the FDA de novo pathway. AspyreRx therapy — formerly BT-001 — provides CBT to patients 18 years or older with type 2 diabetes.
The therapy provides a tailored experience to help patients make changes to improve their diabetes management. Better Therapeutics offers AspyreRx through a smartphone app over a 90-day treatment period.
Data demonstrated statistically and clinically significant durable reductions in A1c versus standard of care with AspyreRx. Better Therapeutics’ randomized controlled trial also resulted in statistically significant improvements in blood pressure, weight, mood and quality of life.
Better Therapeutics CCO Diane Gomez-Thinnes said the company has a three-fold mission with AspyreRx. It wants to mitigate the burden of diabetes, assist in meaningful behavior change and expand access to acre, particularly in underserved communities.
“With the launch of AspyreRx, providers now have a clinically proven treatment delivered in an easily accessible, engaging and affordable way. Behavior modification can be powerful medicine that is valuable at any stage of the disease and since it is already included in current treatment guidelines, we envision AspyreRx becoming part of the standard of care for adults with T2D,” said Frank Karbe, CEO of Better Therapeutics.
