The FDA approved MamaLift Plus as a prescription‐only digital therapeutic for patients aged 22 years and older in conjunction with clinician‐managed outpatient care. Image Credit: Arsenii Palivoda / Shutterstock.

Curio Digital Therapeutics has received 510(k) clearance from the US Food and Drug Administration (FDA) for its prescription digital therapeutic device, MamaLift Plus, as a symptomatic treatment for postpartum depression (PPD).

The FDA approved MamaLift Plus as a prescription‐only digital therapeutic for patients aged 22 years and older in conjunction with clinician‐managed outpatient care. It is intended to be administered over eight weeks for the treatment of mild to moderate PPD.

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MamaLift plus approval was based on the positive data from the Supporting Maternal Mental Health and Emotional Regulation (SuMMER) trial (NCT05958095). The placebo (sham)-controlled pivotal study enrolled 141 patients who had recently had a live birth and were diagnosed with PPD.

The trial met its primary endpoint of improvement of four or more points on the Edinburgh Postnatal Depression Scale (EPDS) score. A clinically meaningful improvement (at least four-point improvement in EPDS) was seen in 86.3% of patients in the MamaLift Plus arm, compared to 23.9% of patients showing improvement in the placebo arm.

MamaLift Plus delivers digital Cognitive Behavioural Therapy (CBT), Behavioural Activation Therapy (BAT), Interpersonal Therapy (IPT), and Dialectical Behaviour Therapy (DBT) for postpartum depression through the patient’s smartphone or tablet. Digital therapies aim to address the maladaptive behaviours, routines, and dysfunctional thoughts that perpetuate during PPD.

There has been an increase in the number of new digital therapeutics for a variety of conditions. Mental health is one of the areas that has incorporated the use of digital therapies.

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In June 2023, the UK’s National Institute of Health and Care Excellence (Nice) approved nine new digital therapies for patients with mental health illnesses to be used in the country’s National Health Service (NHS). The recommendation includes six therapies for anxiety disorders and three for depression.

France has also introduced a Prise en Charge Anticipée (PECAN) initiative for rapid reimbursement of CE-marked digital medical devices (DMDs) specifically designed for remote medical monitoring or therapeutic purposes.