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First mobile app cleared by FDA for substance use disorders

First time, a mobile application has been approved by FDA for treating substance-use disorders. The application, designed by a start-up Pear Therapeutics, is developed to be advised by the clinicians and used along with counseling. The technology of Peer digitizes a type of talk therapy known as cognitive behavioral therapy (CBT) that concentrates on “analyzing the relationships between feelings, behaviors, & thoughts, as per the National Alliance on Mental Illness.

Analysis has shown CBT to be an effective therapy for substance-use disorders, and latest study proposes that it can be directed online through mobile app or desktop. Misuse of illicit drugs, tobacco, and alcohol costs above $740 Billion yearly in the US only. Drug-associated demises have tripled since 2000, as per the National Institute on Drug Abuse.

The app, dubbed Reset, received a nod from the FDA after evaluating the outcomes from a 12-week clinical study. Around 400 individuals were enrolled and given standard therapy or standard therapy along with the Reset app’s desktop version. The outcome witnessed a “statistically significant rise” in adherence to self-denial from cocaine, alcohol, stimulants, & marijuana, as stated by the FDA.

The individual can download the app and activate it with the prescription access code provided by the clinician. A 12-week digital neurobehavioral treatment was received by patients dependent on the Community Reinforcement Approach. The progress of the patient can be tracked by the clinician through the system itself.

The CEO and President of Pear Therapeutics, Corey McCann, said, “This is a significant instance for digital therapeutics and substance use disorder for patients. As the foremost FDA-approved Prescription Digital Therapeutic for treating the disorder, Reset has shown enhanced self-denial and treatment maintenance in a controlled, randomized clinical study. We consider that prescription digital therapeutics embrace assurance in enhancing patient results across a broad array of CNS disorders, including neurology, pain, & psychiatry, and will become an imperative element of treatment paradigm of tomorrow across all disease domains. Pear was overwhelmed by the collaborative approach taken by the FDA in assessing this ground-breaking technology.”

The FDA’s Director for FDA’s Division of Neurological and Physical Medicine Devices, Carlos Peña, said, “This is an exemplar of how pioneering digital technologies can assist in offering patients access to supplementary devices during their therapy. More therapy devices mean a better potential to aid improve results, including self-denial, for substance use disorder patients.”

The Reset app has not yet been permitted to treat opioid addiction, but McCann said the firm has designed software version that is at present under submission. It is developed to be used together with opioid replacement therapies.


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Tushar’s deep knowledge of domains such as Business Technologies, Artificial Intelligence, connected devices, and virtual reality among others makes him a valuable resource. With incredible experience in writing, he brings noteworthy insights and a fresh perspective on various topics. From current affairs to historical milestones, Tushar is well versed with the news that matters the most. As a contributor he promises to enlighten the readers with information that are unbiased and accurate.

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