In a digital first for pharma, Novartis signs on to market Pear's drug-abuse therapies

Pear Therapeutics
Screenshots from Pear Therapeutics' FDA-approved reSET digital software to treat substance abuse. The company is working with Novartis to take the product to market. (Pear Therapeutics)

Novartis and Pear Therapeutics are partnering again, this time in a go-to-market deal focused on two prescription-only digital therapeutics for drug abuse.

Novartis’ Sandoz unit will take on sales and marketing for reSET and reSET-O, putting together a field sales team and detailing the products to doctors. Meanwhile, Pear will manage the digital end of the software-based products and tweak them based on real-world feedback from clinicians and patients, Pear CEO Corey McCann, M.D., Ph.D., said in an interview.

It's the first time a drugmaker will directly detail a digital therapeutic treatment, and the deal follows another first from the partners: Six weeks ago, the two companies announced they'd work together on digital therapies for multiple sclerosis and schizophrenia, making Novartis the first pharma company to inject digital therapeutics into its traditional development pipeline.

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Pear’s digital therapeutics are either FDA-approved or moving through FDA review. They're “effectively software as a drug,” McCann explained. “It is patient-facing software that’s run through clinical studies and demonstrates efficacy and lines up with efficacy claims to directly treat a disease.”

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The FDA approved Pear's reSET product last September for patients with substance-use disorder, and reSET-O—specifically for opioid use disorder—got on the agency's Expedited Access Pathway in October. The two are based on a type of cognitive behavioral therapy called community reinforcement.

The 90-day mobile medical app system requires patients to complete modules similar to the training patients would get in face-to-face therapy sessions, McCann said. ReSET is approved to work in conjunction with outpatient talk therapy, while reSET-O is up for approval to be used alongside the opioid-replacement drug buprenorphine. Both include a clinician dashboard.

“This is less about being digital and more about the efficacy that’s produced,” McCann said. “When you look at things like substance use disorder and opioid use disorder, the pipeline is very bleak and there is very little set to come to this patient population in the next decade. What we’ve been able to demonstrate in clinical studies is really a superiority set of claims.”

RELATED: Pear raises $50M to market digital substance abuse therapy

The software has shown in studies that it's twice as effective as traditional face-to-face therapy, and even better in refractory patients, where efficacy rates were five to 10 times better, McCann said.

Pear has a full pipeline of digital therapeutics, and it’s on track to bring one to market every year. The company does work with other pharmas besides Novartis, McCann said, and he expects that to continue, just as drugmakers work with various partners when bringing their treatments to market.

“What we’ve seen for quite some time is pharma having an understanding that digital was interesting, but not really knowing how they played in the space. I think you’re seeing a bit of what we would affectionately call ‘warhead mentality’ with pharma acknowledging there is something very interesting in digital therapeutics," he said. “(Now) they’re all pushing into the space either by themselves or in some form of collaboration.”