The First Digital Therapeutic for Maternal Mental Health is Approved by the FDA
By the Policy Center for Maternal Mental Health
Curio’s MamaLift Plus™ is an eight-week prescription digital therapeutic that provides symptomatic relief for postpartum depression.
Digital therapeutics (DTx) represent a promising frontier in healthcare, leveraging app-based software to deliver targeted interventions for various health conditions. Digital therapeutics are prescribed by healthcare providers and are subject to rigorous clinical evidence requirements and regulatory oversight, similar to medication or medical devices.
This week, the first DTx for maternal mental health, MamaLift Plus™, was approved by the FDA. The treatment, developed by Curio, was studied by randomized control trial. Patients with mild to moderate postpartum depression who used the treatment improved by four or more points on the Edinburgh Postnatal Depression Scale (EPDS).
The prescribed app leverages proprietary algorithms and personalized digital behavioral interventions to facilitate timely identification and care. The treatment provides bite-sized daily lessons based on Cognitive Behavioral Therapy (CBT) and Interpersonal Therapy (IPT), on-demand, self-paced lessons developed by experts, the ability to uncover trends & gain actionable insights on mood, activity, sleep, & health vitals tracking, and includes live health coaches & therapists.
The app is to be used as an adjunct to clinician‐managed outpatient care.
According to the company, the FDA-approved program/app will be available in summer 2024. The Policy Center’s menu of treatment options will be updated when this new product hits the market.
As the range of new treatments for maternal mental health disorders evolve, the Policy Center will continue to monitor and report on the availability as well as access and coverage issues related to these treatments, including digital therapeutics, as these treatments hold significant promise in expanding the toolkit available to healthcare professionals, ultimately enhancing the quality of care for patients.