Sam Brusco, Associate Editor04.24.24
Curio Digital Therapeutics has received U.S. Food and Drug Administration (FDA) clearance for MamaLift Plus, the first prescription digital therapeutic to treat postpartum depression (PPD).
MamaLift Plus provides neurobehavioral interventions for patients aged 22 and older as adjunct to clinician-managed outpatient care. It treats mild to moderate postpartum depression by improving the patient’s symptoms of depression, according to the company.
It delivers cognitive behavioral therapy (CBT), behavioral activation therapy (BAT), interpersonal therapy (IPT), and dialectical behavior therapy (DBT) for postpartum depression. CBT, BAT, IPT, and DBT are neurobehavioral treatments that focus on addressing the maladaptive behaviors, routines, and dysfunctional thoughts that perpetuate during postpartum depression.
MamaLift Plus can be used on a smartphone or tablet.
“Our goal has always been to provide innovative solutions for women’s health, specifically around the challenges they face with behavioral health. 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,” said Shailja Dixit, MD, MPH, MS, CEO and founder of Curio Digital Therapeutics.
The study met its primary endpoint, improvement of four or more points on the Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a clinically validated screener that is recommended by the American College of Obstetricians and Gynecologists (ACOG). In the intent-to-treat (ITT) population, 86.3% (82/95) of participants in the MamaLift Plus arm achieved a clinically meaningful improvement, versus in the sham control arm, where only 23.9% (11/46) of participants achieved a four-point improvement with a p-value <0.0001.
MamaLift Plus provides neurobehavioral interventions for patients aged 22 and older as adjunct to clinician-managed outpatient care. It treats mild to moderate postpartum depression by improving the patient’s symptoms of depression, according to the company.
It delivers cognitive behavioral therapy (CBT), behavioral activation therapy (BAT), interpersonal therapy (IPT), and dialectical behavior therapy (DBT) for postpartum depression. CBT, BAT, IPT, and DBT are neurobehavioral treatments that focus on addressing the maladaptive behaviors, routines, and dysfunctional thoughts that perpetuate during postpartum depression.
MamaLift Plus can be used on a smartphone or tablet.
“Our goal has always been to provide innovative solutions for women’s health, specifically around the challenges they face with behavioral health. 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,” said Shailja Dixit, MD, MPH, MS, CEO and founder of Curio Digital Therapeutics.
More about the technology
The clearance of MamaLift Plus is based on results from the Supporting Maternal Mental Health and Emotional Regulation (SuMMER). 141 participants who had recently had a live birth and were diagnosed with PPD were enrolled in the study.The study met its primary endpoint, improvement of four or more points on the Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a clinically validated screener that is recommended by the American College of Obstetricians and Gynecologists (ACOG). In the intent-to-treat (ITT) population, 86.3% (82/95) of participants in the MamaLift Plus arm achieved a clinically meaningful improvement, versus in the sham control arm, where only 23.9% (11/46) of participants achieved a four-point improvement with a p-value <0.0001.