Pear nabs $20M to woo FDA, launch prescribable apps for substance abuse, medication adherence

reSET patient app--Courtesy of Pear Medical

Biopharmas may be able to command hundreds of dollars a month for prescription medications, but it can be tough to get payers to cough up even a few bucks for an app that may offer comparable levels of benefit. So, one startup, Pear Therapeutics, has adopted the language of biopharma and it is looking to work tightly in tandem with drug companies with medication adherence apps.

The San Francisco-based startup has now raised $20 million to embrace this vision in a venture financing led by 5AM Ventures, Arboretum Ventures, and Jazz Venture Partners with participation from Bridge Builders Collaborative and several additional, undisclosed investors.

If pharma can successfully use these sorts of tools to measurably boost adherence--and sales--of its products by offering tailored apps and web tools that could translate into millions, or even billions, of increased sales. In order to have its apps and tools ultimately prescribed by physicians, Pear Therapeutics is embracing the FDA rather than fleeing from it as so many consumer-facing health app players have opted to do.

reSET app clinician web interface--Courtesy of Pear Medical

Up first, it expects to submit its reSET patient smartphone application and clinician web interface to treat substance use disorder (SUD) to the FDA by the middle of this year.

It's already conducted a pivotal randomized trial of reSET in almost 400 SUD patients seeking treatment related to cocaine, alcohol, cannabis, and stimulants across 10 treatment centers. Patients who got the app in lieu of time with a therapist had "significantly higher rates of abstinence and higher rates of retention in treatment than patients receiving face-to-face therapy alone," the company said.

reSET and reSET-O, a version tailored specifically for opiate dependence, already have been tested in 6 randomized clinical studies involving more than 1,500 SUD patients.

"Given the dearth of treatment options for patients suffering from SUD, we are excited to launch reSET and reSET-O," said Arboretum Ventures Managing Director Tim Petersen in a statement. "These products have demonstrated clinical data supporting enhanced abstinence, enhanced retention in treatment, enhanced quality measures like Addiction Severity Index (ASI), and significantly reduced clinician intervention time. Enhancing efficacy while reducing costs is the Holy Grail for healthcare technology."

eFormulations app--Courtesy of Pear Medical

Up next, Pear is developing what it calls eFormulations: patient app/clinician web products that are tailored to specific brain disorders in order to enhance medication adherence and efficacy. Its schizophrenia product "has already demonstrated patient usability and clinical efficacy in combination with multiple medications," the company said. And the startup is in the midst of "multiple large-scale clinical trials" in schizophrenia, schizoaffective disorder and bipolar disorder patients.

Ultimately, Pear obviously hopes that these "prescription digital therapies" will demonstrate enough value that they will be considered akin to drugs when it comes to reimbursement. But this may be a tough sell for non-governmental U.S. payers that often have patients who cycle in and out of their system within the span of just a couple of years--therefore offering them little incentive for a vision of long-term treatment.

If Pear can offer enough clinical evidence, however, it can hope to win physicians and patients to try its products, thereby forcing the hand of recalcitrant payers.

Summed up Jazz General Partner Zack Lynch, "From mobile applications, to virtual reality, to predictive analytics, Pear's digital therapeutics platform directly boosts medication efficacy, well beyond enhanced compliance. The proof is ultimately in the clinical data, and we are incredibly excited to back the Pear team as they push toward FDA approval, and the delivery of these products to patients."

- here is the announcement