FDA Clears Prescription Digital Therapeutic for Postpartum Depression

The Food and Drug Administration (FDA) has cleared MamaLift Plus, the first prescription digital therapeutic for symptomatic treatment of postpartum depression (PPD).

MamaLift Plus is intended as an adjunct to clinician-managed outpatient care to provide neurobehavioral interventions to patients 22 years of age and older with mild to moderate PPD. It can be used on a mobile device (eg, smartphone or tablet).

The 8-week treatment program uses digital cognitive behavioral therapy, behavioral activation therapy, interpersonal therapy, and dialectical behavior therapy to treat the symptoms of postpartum depression. MamaLift Plus includes daily trackers for sleep, mood, and activities for users to record information. It should not be used by users with severe depression or anxiety, serious mental illness, psychosis, or suicidal thoughts. 

The FDA clearance was based on data from the randomized, sham-controlled SuMMER trial (ClinicalTrials.gov Identifier: NCT05958095), which included 141 patients who had given birth within 3 months prior to the study and were diagnosed with mild to moderate PPD. Study participants were randomly assigned to receive either MamaLift Plus (n=95) or a digital sham app (n=46) for 8 weeks. 

Results showed a higher proportion of patients treated with MamaLift Plus had at least a 4-point improvement on the Edinburgh Postnatal Depression Scale score compared with sham (primary endpoint; 86.3% vs 23.9%, respectively; P <.0001). 

“Our goal has always been to provide innovative solutions for women’s health, specifically around the challenges they face with behavioral health,” said Shailja Dixit, MD, MPH, MS, CEO & Founder of Curio Digital Therapeutics. “MamaLift Plus is the first and only digital solution that can help address the serious unmet need uniquely faced by women who have recently delivered.”

MamaLift Plus prescription-only app will be available in the App Store^® and Google Play^™ store this summer.