Curio Digital Therapeutics Inc. has achieved a significant milestone with the FDA's clearance of MamaLift Plus, marking the first-ever prescription digital therapeutic designed to address postpartum depression (PPD), a complex mental health condition affecting up to one in seven women following childbirth.
MamaLift Plus is specifically tailored for patients aged 22 and older, serving as a complementary tool to clinician-managed outpatient care. This innovative digital solution targets mild to moderate postpartum depression symptoms by delivering neurobehavioral interventions, including Cognitive Behavioral Therapy (CBT), Behavioral Activation Therapy (BAT), Interpersonal Therapy (IPT), and Dialectical Behavior Therapy (DBT) through mobile devices such as smartphones and tablets.
Jean-Pierre Lehner, MD, former Global Chief Medical Officer at Sanofi and a Board Member of Curio, lauds MamaLift Plus as a pioneering advancement in women's healthcare, offering a non-pharmaceutical alternative to address the pressing needs of women post-delivery.
The FDA clearance of MamaLift Plus is underpinned by the compelling results of the Supporting Maternal Mental Health and Emotional Regulation (SuMMER) study, a nationwide, sham-controlled Randomised Controlled Trial (RCT) involving 141 participants recently diagnosed with PPD postpartum.
Shailja Dixit, MD, MPH, MS, CEO & Founder of Curio Digital Therapeutics, expresses the company's commitment to innovating solutions for women's health, particularly in the realm of behavioural health. MamaLift Plus emerges as a groundbreaking intervention tailored to address the unique challenges faced by postpartum women.
The SuMMER study demonstrated MamaLift Plus's efficacy in meeting its primary endpoint of achieving a four-point improvement on the Edinburgh Postnatal Depression Scale (EPDS), a validated screener endorsed by the American College of Obstetricians and Gynecologists (ACOG). Remarkably, 86.3% of participants in the MamaLift Plus arm experienced clinically meaningful improvement, underscoring its effectiveness compared to the control group.
Renowned women's health expert, Alice D. Domar, PhD, a Scientific Advisor to Curio, lauds the development of MamaLift Plus as a significant breakthrough for women grappling with postpartum depression, particularly amidst the scarcity of mental health professionals.
Healthcare providers and patients seeking further information on MamaLift Plus can access resources via Curio Digital Therapeutics' official website. This FDA clearance marks a pivotal moment in women's healthcare, offering new hope and therapeutic avenues for those navigating the challenges of postpartum depression.
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