Health IT

Pear Therapeutics gets greenlight from FDA for addiction treatment via digital therapeutic

The FDA’s clearance for the prescribed app, aimed at individuals as part of outpatient therapy for substance use disorders spanning alcohol, cocaine, marijuana, and stimulants, is a major milestone for digital therapeutics and suggests more companies will seek FDA approval.

In a milestone development for addiction recovery through mobile devices, the U.S. Food and Drug Administration approved marketing for Pear Therapeutics’ prescription reSET app. The program is aimed at individuals as part of outpatient therapy for substance use disorders spanning alcohol, cocaine, marijuana and stimulants.

The company is developing a separate application for treating opioid dependence, called reSET-O.

The regulator approved the app through de novo premarket review —a regulatory pathway used for certain low to moderate-risk devices that are new and have no rival on the market.

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

Positive results from a 12-week, multisite, unblinded clinical trial of reSET were used to justify the FDA’s marketing approval. Of the 399 patients who received either standard treatment or standard treatment with a desktop version of reSET, that could be accessed at trial site or at home, more than 40 percent who used reSET were able to stay away from alcohol, cocaine, marijuana and stimulant. For those who did not use reSET as part of their substance use disorder therapy, only 17.6 percent of patients were abstinent.

Last year, Pear Therapeutics raised $20 million partly for the commercial launch of reSET and to advance the company’s other digital therapeutics. Among the investors in that round were 5AM Ventures, Arboretum Ventures, and JAZZ Venture Partners, and Bridge Builders Collaborative.

Several digital health companies, such as Workit Health, Ascent and Addicaid,  have taken an interest in developing tools for substance use disorders, particularly for opioid addiction which is a public health crisis that many states are struggling to address.

Photo: bandit2523, Getty Images,