AspyreRx is the first FDA-authorized digital behavioral therapeutic device delivering cognitive behavioral therapy for the treatment of a cardiometabolic disease
As previously reported, adding AspyreRx to standard of care resulted in significant and durable reductions in A1c as well as improvements in a host of other health measures
Healthcare providers in the U.S. can now begin prescribing AspyreRx
SAN FRANCISCO–(BUSINESS WIRE)– Better Therapeutics, Inc. (NASDAQ: BTTX), a pioneer in developing prescription digital therapeutics (PDTs) to treat cardiometabolic diseases, today announced the commercial launch of AspyreRx, the first cognitive behavioral therapy (CBT) app to receive U.S Food and Drug Administration (FDA) authorization as a Class II device to treat adults with type 2 diabetes (T2D). AspyreRx is a prescription-only therapy, backed by a randomized controlled trial (RCT) that demonstrated statistically and clinically significant durable reductions in A1c at 90 and 180 days vs. the standard of care control group. The RCT also resulted in statistically significant improvements in blood pressure, weight, mood, and quality of life, as well as having lower medication utilization and fewer adverse events vs. the control group. Licensed healthcare providers are now able to prescribe AspyreRx, and the app is available for download on the Apple App and Google Play Stores.
AspyreRx delivers a novel form of CBT developed by Better Therapeutics, specifically for the treatment of T2D. Rooted in the fundamental belief that behaviors are learned and can be transformed through systematic techniques and interventions, AspyreRx provides a tailored experience to help patients make meaningful and sustainable behavioral changes to improve their diabetes management. AspyreRx is accessible through a smartphone app and is prescribed for a 90-day treatment period.
“The impact of diabetes on 37 million people in the U.S. underscores the pressing need to support healthcare providers and patients in addressing the underlying factors contributing to the disease,” said Diane Gomez-Thinnes, Chief Commercial Officer at Better Therapeutics. “Our mission with AspyreRx is threefold: to mitigate the growing burden of diabetes, to assist diabetes patients in achieving meaningful behavior change, and to leverage digital technologies to extend access, particularly in underserved communities.”
A cost effectiveness analysis, which was part of a broader Health Economics and Outcomes Research (HEOR) conducted by Better Therapeutics, suggests that AspyreRx was cost-effective as compared to standard of care, indicating the potential for AspyreRx to not only yield better health outcomes than current standard of care alone, but also to demonstrate cost savings for payers. The Company continues to make progress towards obtaining commercial payer coverage, while also advancing its efforts to get on the Federal Supply Schedule. During the initial launch phase, as the Company works on securing insurance coverage, eligible patients can access AspyreRx on a cash-pay basis for a limited time.
“The need for novel, innovative and effective solutions for people living with type 2 diabetes has never been more urgent,” said David Kerr, MBChB, DM, FRCP, FRCPE, Director of Digital Health at the Diabetes Technology Society. “AspyreRx has the potential to overcome the limitations of traditional behavior change approaches, offering infinite scalability as a digital solution for people who, previously, have been excluded. By providing a structured approach to behavior modification, AspyreRx can empower people with diabetes in ways that healthcare providers, often constrained by time and training, frequently find challenging to achieve. AspyreRx is a compelling example of how technology can revolutionize traditional healthcare, making treatments accessible to those who have until now not had access, leading to clinically relevant improvements for the many rather than the few.”
“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, Chief Executive Officer of Better Therapeutics.
AspyreRx (formerly BT-001) was granted marketing authorization by the U.S. Food and Drug Administration (FDA) in July 2023 as the first prescription-only digital therapeutic to treat adults with type 2 diabetes (T2D). AspyreRx is backed by robust data demonstrating clinically meaningful and sustained reduction in A1c as well as improvements in other markers of cardiometabolic health when used up to 180 days. Using proven techniques that target the underlying psychological, behavioral, and cognitive factors that sustain or worsen T2D, AspyreRx is a self-paced, engaging experience that patients can access from their smartphone. It is prescribed by a healthcare provider in 90-day increments, with proprietary CBT delivered digitally in a weekly step-by-step process. Through interactive therapy lessons, skill-building modules, weekly goal setting and tracking, patients connect changes in behavior to improvements in blood sugar and other biometrics. Each step in the experience builds on the prior to enable and reinforce cognitive restructuring, building the emotional resilience and acceptance needed to make enduring changes.
Indications for Use
AspyreRx is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes. The device targets behavior to aid in the management of type 2 diabetes in patients who are under the care of a healthcare provider. AspyreRx provides cognitive behavioral therapy as a treatment that should be used adjunctively with standard of care.
About Better Therapeutics
Better Therapeutics is a prescription digital therapeutics company developing a novel form of cognitive behavioral therapy to address underlying factors that sustain or worsen cardiometabolic diseases. The Company has developed a proprietary platform for the development of FDA-regulated, software-based solutions for T2D, heart disease and other conditions. The CBT delivered by Better Therapeutics’ PDT is designed to enable changes in neural pathways of the brain so lasting changes in behavior become possible. Addressing the underlying causes of these diseases has the potential to dramatically improve patient health while lowering healthcare costs. Better Therapeutics’ clinically validated mobile applications are intended to be prescribed by physicians and reimbursed like traditional medicines.
Certain statements made in this press release are “forward-looking statements” within the meaning of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are typically identified by words such as “plan,” “believe,” “expect,” “anticipate,” “intend,” “outlook,” “estimate,” “forecast,” “project,” “continue,” “could,” “may,” “might,” “possible,” “potential,” “predict,” “should,” “would” and other similar words and expressions, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements in this press release include, but are not limited to, statements regarding Better Therapeutics’ expectations related to the efficacy and potential benefits of PDTs, including AspyreRx and CBT, and their potential treatment applications and their ability to improve clinical outcomes, beliefs regarding the importance and potential of behavior modification in diabetes treatment and statements related to the needs of people living with T2D, among others. These forward-looking statements are based on the current expectations of the management of Better Therapeutics and are inherently subject to uncertainties and changes in circumstances and their potential effects and speak only as of the date of such statement. There can be no assurance that future developments will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements including: risks related to Better Therapeutics’ business, such as the willingness of the FDA to authorize PDTs, for commercial distribution and insurance companies to reimburse their use, market acceptance of PDTs, including AspyreRx, the risk that the results of previously conducted studies will not be interpreted favorably by the FDA or repeated or observed in ongoing or future studies involving Better Therapeutics’ product candidates and other risks and uncertainties included under the header “Risk Factors” in Better Therapeutics’ quarterly report on Form 10-Q for the quarter ended June 30, 2023 filed with the Securities and Exchange Commission (SEC) on August 9, 2023, and those that are included in any of Better Therapeutics’ subsequent filings with the SEC.