SparkRx depression therapeutic shown to cut depression symptoms in adolescents
pharmafile | October 11, 2021 | News story | Sales and Marketing | FDA, Limbix, SparkRx
A new digital therapeutic available for use without prescription under the FDA’s emergency guidance for digital health devices has shown to cut depression symptoms in young people. The results from Limbix mean that it will likely move towards filing for FDA approval.
The digital platform uses cognitive behavioral therapy and works alongside a clinician. The Phase II clinical trial, NCT04524598, which enlisted 121 participants with moderate to severe depression systems, showed a clinically meaningful reduction in depression symptoms. 24% of SparkRx participants had a treatment response, while 17% were in remission.
Limbix, a prescription digital therapeutic company, announced the results of this trial at 2021 American Academy of Pediatrics National Conference by Benjamin Aloud, Chief Medical Officer of Limbix, in a poster presentation: A CBT-based Digital Therapeutic is Effective in Reduced Symptoms of Depression in Adolescents.
No participants experienced a serious adverse event following the treatment, nor any unanticipated device effect.
Dr Alouf said: “At a time when more than one in five young people are struggling with depression, suicide attempts are rising, and we have a critical shortage of mental health specialists, SparkRx is an evidence-based solution that primary care providers can immediately offer their patients.
“We are very encouraged by these promising results and believe that SparkRx has the potential to address the growing mental health crisis in the US and the need for improved access to treatment for our youth. Supported by our positive results, we are launching SparkRx and making it available for a limited time at no cost to patients or providers.”
Will Brown
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