The US Food and Drug Administration (FDA) has granted clearance to a prescription digital therapeutic for postpartum depression.
Postpartum depression is a type of depression that happens after giving birth. It affects up to one in seven US women within a year of giving birth.
MamaLift Plus, developed by Curio Digital Therapeutics, is the first digital therapeutic for the treatment of postpartum depression.
The solution, which can be used on a mobile device, is a prescription‐only digital therapeutic intended to provide neurobehavioral interventions to patients 22 years of and older, as an adjunct to clinician‐managed outpatient care.
It treats mild to moderate postpartum depression through digital cognitive behavioural therapy, behavioural activation therapy, interpersonal therapy and dialectical behaviour therapy.
“Our goal has always been to provide innovative solutions for women’s health, specifically around the challenges they face with behavioural health,” said Dr Shailja Dixit, founder and CEO 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.”
Dixit told Femtech World: “It was a pleasure working alongside the FDA on such a monumental step forward in improving access to care and treatment options for women struggling with postpartum depression.
“We applaud the collaborative effort involved for pushing this new frontier forward.”
The clearance of MamaLift Plus was based on results from the Supporting Maternal Mental Health and Emotional Regulation (SuMMER), a national randomised controlled trail of 141 participants, who had recently had a live birth and were diagnosed with postpartum depression.
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).
Jean-Pierre Lehner, ex-Global CMO Sanofi, and board of director Curio, said: “MamaLift Plus opens a new chapter of prescribed digital therapeutics that provide women with a non-pharmaceutical alternative.
“I am happy to support this groundbreaking innovation.”
Alice D. Domar, women’s health expert and Curio scientific advisor, added: “This is an incredible development for women suffering from postpartum depression who are looking for non-pharmaceutical alternatives given the shortage of trained mental health professionals.”
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The post FDA clears prescription digital therapeutic for postpartum depression appeared first on FemTech World.
The post FDA clears prescription digital therapeutic for postpartum depression appeared first on FemTech World.