Prescription digital therapeutic for postpartum depression receives FDA 510(k) clearance
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Key takeaways:
- MamaLift Plus treats postpartum depression through delivery of neurobehavioral interventions to women aged at least 22 years.
- In the SuMMER trial, MamaLift Plus improved postpartum depression for 86.3% of women.
An 8-week prescription digital therapeutic for treatment of postpartum depression symptoms received FDA 510(k) clearance, according to a press release from Curio Digital Therapeutics.
MamaLift Plus is the first prescription digital therapeutic to treat mild to moderate postpartum depression symptoms in women aged 22 years and older through delivery of cognitive behavioral therapy, behavioral activation therapy, interpersonal therapy and dialectical behavior therapy. The therapeutic can be used on mobile devices, including smartphones and tablets, according to the release.
“Our goal has always been to provide innovative solutions for women’s health, specifically around the challenges they face with behavioral health,” Shailja Dixit, MD, MPH, MS, CEO and founder of Curio Digital Therapeutics, said in the press release. “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.”
The FDA clearance is based on results from Supporting Maternal Mental Health and Emotional Regulation (SuMMER), a national, placebo-controlled randomized controlled trial that enrolled 141 women with postpartum depression who recently had a live birth. In the study, women were randomly assigned to the MamaLift Plus or placebo group. In the MamaLift Plus group, women used the intervention daily for 8 weeks, and efficacy was measured by the Edinburgh Postnatal Depression Scale (EPDS).
Results demonstrated that 86.3% of women in the MamaLift Plus group achieved clinically meaningfully improvement in postpartum depression of four or more points on the EPDS compared with 23.9% of women in the placebo group.
“This is an incredible development for women suffering from postpartum depression who are looking for nonpharmaceutical alternatives given the shortage of trained mental health professionals,” Alice D. Domar, PhD, scientific adviser for Curio Digital Therapeutics, said in the release.