BOSTON and SAN FRANCISCO, Sept.14, 2017 /PRNewswire/ — Pear Therapeutics, the leader in a new era of prescription digital therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Pear’s De Novo request, allowing the company to market reSET® for the treatment of patients with substance use disorder (SUD) under a new class of treatment. This is the first time that the FDA has cleared a Prescription Digital Therapeutic with claims to improve clinical outcomes in a disease.
“This is a defining moment for digital therapeutics and for patients with substance use disorder,” said Corey McCann, President and Chief Executive Officer of Pear Therapeutics. “As the first FDA-cleared Prescription Digital Therapeutic for disease treatment, reSET® has demonstrated improved abstinence and treatment retention in a randomized controlled clinical study. We believe that prescription digital therapeutics hold promise in improving patient outcomes across a wide range of central nervous system disorders including psychiatry, neurology and pain, and will become a vital part of tomorrow’s treatment paradigm across all disease areas. Pear was impressed by the collaborative approach the FDA took in reviewing this innovative technology.”
reSET® is a 12-week duration, FDA-cleared Prescription Digital Therapeutic to be used in conjunction with standard outpatient treatment for substance use disorder related to stimulants, cannabis, cocaine, and alcohol. reSET® is not intended to be used to treat opioid dependence. The product combines patient-facing interventions and assessments via a mobile device, with clinician-facing dashboards and data analytics on the back-end. reSET® has been proven to increase abstinence from a patient’s substances of abuse during treatment and increase patient retention in the outpatient treatment program. reSET® provides access to self-reported substance use, triggers, cravings and outcomes to the patient’s medical provider.
To support the FDA submission of reSET® (academic name: TES), a National Institute on Drug Abuse (NIDA) –sponsored clinical trial evaluated the therapeutic in 399 patients with SUD across 10 treatment centers in NIDA’s Clinical Trial Network nation-wide over 12 weeks. Patients were randomized to either a standard treatment-as-usual, which consisted of standard face-to-face counseling, or to a reduced amount of face-to-face counseling plus the digital therapeutic. The clinical study demonstrated that the digital therapeutic more than doubled the rate of abstinence compared to standard, face-to-face counseling. In a sub-group analysis of non-abstinent patients at study start, a poor prognostic indicator, patients randomized to the digital therapeutic demonstrated an almost five-fold improvement in abstinence.
“In 2016, an estimated 20.1 million people aged 12 or older needed substance use disorder treatment according to the Substance Abuse and Mental Health Services Administration,” said Edward V. Nunes, MD, Professor of Psychiatry at Columbia University Medical Center and independent Lead Investigator on the clinical study submitted to the FDA. “The clinical outcomes demonstrated in the reSET® pivotal study are remarkable. Clinically-validated digital therapeutics may become a cornerstone of future treatment.”
“reSET® has the opportunity to radically enhance the treatment options for patients with substance use disorder. These digital therapeutics equip clinical professionals with the ability to provide more immediate and convenient care to their patients,” said Advisory Board Chairman for Pear Therapeutics and Former Congressman, Patrick J. Kennedy. “I am proud to support Pear Therapeutics and their commitment to develop technologies for those living with mental health and substance use disorders.”
About Substance Use Disorder (SUD)
In 2016, approximately 20.1 million people aged 12 or older had a substance use disorder (SUD) related to their use of alcohol or illicit drugs in the past year. Abuse of and addiction to alcohol, nicotine, and illicit and prescription drugs cost Americans more than $700 billion a year in increased health care costs, crime, and lost productivity, and contribute to the death of more than 90,000 Americans.
reSET® Indications for Use
reSET® is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET® is indicated as a 12-week prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to:
Full prescribing information can be found at www.peartherapeutics.com.
About Prescription Digital Therapeutics
Prescription digital therapeutics are clinically validated, FDA-cleared software applications that demonstrate safety and efficacy in randomized clinical trials to improve patient outcomes. They are designed to enhance clinical outcomes, and where clinically relevant may be combined with current treatment regimens including approved drug or device therapies. Prescription digital therapeutics usually include patient-facing applications, clinical assessment and outcomes tracking, clinician monitoring dashboards and HIPAA-compliant data storage.
About Pear Therapeutics
Pear Therapeutics is the leader in FDA-cleared Prescription Digital Therapeutics. The company’s approach is to integrate clinically-validated software applications with previously approved pharmaceuticals and treatment paradigms to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear’s lead product, reSET®, is an FDA-cleared 12-week interval prescription therapeutic for Substance Use Disorder (SUD) to be used as an adjunct to standard, outpatient treatment. Pear’s product development pipeline includes reSET®-O™ for opioid use disorder (OUD) and additional prescription digital therapeutics in schizophrenia (Thrive™), combat posttraumatic stress disorder (reCALL™), general anxiety disorder (reVIVE™), pain, major depressive disorder, and insomnia, for which Pear intends to obtain FDA clearance. For more details, please see www.peartherapeutics.com.
Millions of Americans’ health is at risk today, but there is an easy solution – technology. Consider that 75 million Americans have hypertension according to the Center for Disease Control and Prevention. An additional one in three Americans have prehypertension- blood pressure numbers that are higher than normal. Patients with prehypertension can make lifestyle changes to lower blood pressure naturally and prevent full blown hypertension.
But for most people behavior change is hard. Behavior change is possible though, if it is easier for individuals to measure and track progress.
That’s where an emerging category of health technology called digital therapeutics comes in. Digital therapeutics, commonly defined as technology that can improve a person’s health equal to a drug, but without the same costs and side-effects, can empower individuals to change their behavior and improve their health. With the use of digital therapeutics individuals can manage chronic conditions and try alternate treatments to accompany or even replace pharmaceuticals.
Here are three examples of Consumer Technology Association (CTA) member companies making a difference in lives with digital therapeutics:
2breathe Technologies created RESPeRate, a solution for individuals to manage hypertension through timed breathing exercises that naturally lower heartrate and blood pressure. Remember being told to breathe slowly and count to ten when you are stressed? That could have been the best advice you ever received if you’re hypertensive.
Livongo, created a glucose meter and diabetes monitoring system that gives patients a connected platform with real-time coaching to prevent diabetic episodes and adjust insulin levels to improve health and well-being. The ability to control how you feel when you’ve been diagnosed with a disease that makes you feel powerless is unbelievably powerful.
Quell has developed a FDA approved drug free solution to treat chronic pain. Through advanced neurotechnology, Quell taps into the user’s natural pain relief response. The Quell app allows patients to track progress, change therapies and understand their treatment in real-time. Delivering pain management without the use of opioids could save thousands of lives.
These solutions are game changers and the key is patient empowerment. Empowerment isn’t limited to the patient though, digital therapeutics also empower doctors with real time patient generated data and in some instances, lifesaving information. CTA’s research shows that the U.S. could reach a critical mass of physicians using patient generated data by 2020. The combination of the empowered patient and technology friendly physician could lead to overall better health outcomes and reduce healthcare costs in America.
The increased adoption of these solutions is exciting, but new questions, opportunities and challenges come with this promising new category of health technology. So what’s CTA doing to help? A lot.
CTA recently partnered with the Personal Connected Health Alliance to conduct research on digital therapeutics that will focus on understanding the state of the category and explore potential opportunities for new developments. We lobbied the Center for Medicare and Medicaid Services (CMS) to reimburse doctors for time spent reviewing data from remote monitoring devices and digital therapeutics. We know device accuracy and data validity is important to physicians and consumers, so we created standards for step counting, heart rate capture and sleep monitoring. Lastly, we know privacy is key so we wrote Guiding Principles of the Privacy and Security of Personal Wellness Data. We’ll discuss this work and hear from the companies leading the way in digital therapeutics during the Disruptive Innovations in Healthcare conference at CES 2018.
What if an app could replace a pill? That’s the big question behind an emerging trend known as “digital therapeutics.” The idea: software that can improve a person’s health as much as a drug can, but without the same cost and side-effects.
Digital therapeutics, or “digiceuticals,” as some call them, have become a Holy Grail in some quarters of Silicon Valley, where investors see the chance to deliver medicine through your smartphone. Andreessen Horowitz, the venture firm, even predicts digital drugs will become “the third phase” of medicine, meaning the successor to the chemical and protein drugs we have now, but without the billion-dollar cost of bringing one to market.
“It’s going to seem backwards and even barbaric that our solution to everything was just giving out pills,” partner Vijay Pande wrote on the investment company’s blog.
But defining exactly what a digital therapeutic actually is can be as elusive as finding the famous chalice. “It’s still a fluid space that everyone is trying to categorize,” says Peter Hames, the British CEO of a startup called Big Health, which offers an online therapy program for insomnia suffers called sleep.io that it claims can replace “pills or potions” with visualization exercises.
Hames says digital therapies fall into two groups, which he calls “medication augmentation” and “medication replacement.” He says sleep.io is in the latter category because it actually makes sleeping pills unnecessary. “We’ve been able to show through multiple peer-reviewed studies that the outcomes are better than drugs,” he says.
The term digital therapeutics began to circulate around 2013, in large part due to Sean Duffy, CEO of Omada Health. He began using it at conferences and in the company’s marketing materials to describe its online coaching software to help pre-diabetics avoid getting sick by exercising more and losing weight.
About a dozen startups now call themselves digital therapeutics providers, and say they’re distinct from the rest of the digital health market of activity monitors, smart scales, and sleep trackers.
To distinguish themselves from “wellness” gadgets, digital therapeutics companies tend to carry out clinical tests and sometimes seek regulatory approvals –one company, Welldoc, offers a prescription-only version of its BlueStar phone app for managing diabetes, which it terms the “first FDA-cleared mobile prescription therapy.” But unlike drugs, digital therapeutics don’t usually need approval by the U.S. Food and Drug Administration, since often they promote lifestyle or dietary changes that are deemed to be low-risk.
Whether a digital therapeutic involves a tracking sensor or coaching though an app, the biggest question is whether they provide a distinct, measureable medical benefit. One startup calling itself a digital therapeutics company is Virta Health, based in San Francisco. The company raised $37 million in March. Its goal is to actually “reverse” diabetes without drugs or surgery using online coaching to get people on a special diet high in fats and low on carbs. It has a study by Indiana State University to back up the claim—about half of the 262 people with type 2 diabetes enrolled in a 10-week trial were able to reduce their blood glucose levels to non-diabetic ranges.
Steve Kraus, an investor at Bessemer Venture Partners, says he thinks digital therapeutics will be a “real thing, I really do,” but he says it’s not clear how many people will succeed with lifestyle intervention in the long run. Instead, he says, digital therapeutics used “in combination” with drugs, to make them work better, could be the idea’s sweet spot.
What’s the most serious disease that a “digital” treatment could cure?
Some digital companies are already allying with pharmaceutical makers. One, Propeller Health, inked a deal with GlaxoSmithKline for what it calls a “digitally guided therapy” platform. The approach combines Glaxo’s asthma medications with sensors, made by Propeller, that patients attach to their inhalers to monitor when they’re used. Patients who get feedback from Propeller’s app end up using the medication less often.
To win adoption, digital therapeutics companies have striven to mimic the drug industry’s practices and standards. Big Health, based in San Francisco, went as far as testing a placebo version of its insomnia app against the real thing. One group of insomnia-sufferers were given plausible-sounding, but fake, online visualization exercises; the other received the actual cognitive behavioral therapy that Big Health says works. The digital treatment “absolutely spanked the placebo,” says Hames.
Hames believes that someday digital therapeutics companies may even outstrip drug companies when it comes to evidence. “We’re digital, so we’re going to have a firehose of data,” he says. Drugmakers don’t always track real-world results of their pills once clinical trials are done. But digital therapeutics companies could easily keep getting data. “It’s not in the drug company’s interest because they have already sold the drug,” he says. “Meanwhile, the insurance companies will say to us, ‘You have the data, so why don’t you just tell us?’”
Some drug company executives remain skeptical. Robert Plenge, vice president at Merck’s research labs, had to look up “digital therapeutics” when asked whether they were important. “I don’t totally understand what you mean,” he says. “Which might in and of itself be your answer.” Plenge doesn’t think the idea would have much impact on drug development and questioned whether digital companies will be able to prove their offerings are worth the price.
But some digital therapies are already much cheaper than your average drug. At Big Health, people are charged $400 a year, or about $33 a month, to use the insomnia software. The sleeping pill Ambien, by contrast, costs $73 for six tablets, or six nights of shut-eye.
A notable difference is that insurance often pays most of the cost of drugs and insurers are still getting used to digital therapeutics. Omada Health in 2016 again broke ground when Medicare agreed to reimburse the cost of its digital diabetes prevention program. The company didn’t say how much it bills employers and insurance plans, but it would charge a self-paying customer $140 a month for the first four, then $20 per month.
Ambar Bhattacharyya, with Maverick Ventures, says he thinks insurers are ready to talk about covering digital therapies more widely. “This is an imminent issue that I suspect will be figured out within a year,” he says. If it’s good news, he says, the space is poised to explode.
Source: Technology Review
Last month, healthcare startup Omada Health secured a $50 million C round led by major insurer Cigna, which brings the 5-year-old company’s total funding to over $127 million. That kind of nine-figure investment isn’t unusual for a company with the next blockbuster drug or game changing medical device, but Omada’s core product is a diabetes-preventing mobile app! Omada is a leader in one of the hottest new sectors of the app economy: Digital Therapeutics.
Digital therapeutics are a new category of apps that help treat diseases by modifying patient behavior and providing remote monitoring to improve long-term health outcomes. Depending on the disease, they can encourage patients to stick to diet and exercise programs or help them adhere to drug intake regimes. Wait a minute, doesn’t that sound a lot like wellness apps? There are already hundreds of apps that help us manage our workouts or meditate more effectively!
The key difference is that digital therapeutics implement treatment programs tailored to specific ailments, especially major chronic diseases like diabetes, heart disease, high blood pressure, and pulmonary diseases like COPD. Because patient behavior is so crucial in preventing and limiting the severity of these life-threatening illnesses, the early evidence is that these digital health programs, often combined with human coaching/interaction, can make a significant difference in health outcomes.
To provide hard data of their efficacy (and differentiate themselves from wellness apps), newcomers like Omada have taken a page from the pharma industry and have performed clinical trials with major healthcare networks like Humana. In recently published research, prediabetic patients that participated in a year-long Omada-based program lost 7.5% of their initial body weight and showed improved glucose control and decreased cholesterol.
These results are one reason why health insurance firms are among the big investors in the leading startups. Mobile app-based digital treatment programs can be delivered at massive scale and low cost, and by helping to prevent disease progression, can potentially save insurers billions of dollars. On the other side of the equation, the prospect of health insurance covered recurring subscription revenues has VC’s salivating. Omada proved early validation of this prospect when last year it got Medicare to agree to reimburse the cost of its digital diabetes prevention program.
Another reason the insurers are excited about the potential of mobile-delivered health programs is data. Once clinical trials are complete, most pharmaceutical companies don’t track real-world results for their drugs. With precise regimes and daily monitoring, digital therapeutics can offer mountains of data that can potentially provide doctors unprecedented insights into patient behavior and create feedback/optimization loops for individual patients. Enabling patients to take greater control over managing their chronic illnesses and preventing disease progression could yield huge cost savings throughout the entire healthcare system.
Some digital therapeutics is meant to entirely replace medication with behavioral-based treatment, such as apps that use visualization exercises to help insomnia sufferers as an alternative to sleeping pills like Ambien. Others are designed to work in conjunction with medications by helping patients better manage their treatment regimes. A company that has taken this approach is Propeller Health, which makes a sensor that attaches to inhalers used by people who suffer from chronic asthma and COPD. The sensor monitors inhaler usage and provides feedback via a mobile app. Propeller has partnered with GlaxoSmithKline to create a digital therapy platform to guide patients in using its asthma medications.
Another innovative digital drug adherence platform is the one created by startup Proteus Digital Health. Proteus has built an ingestible radio tag the size of a grain of sand. It can be put inside a pill and can send data to a wearable patch on the patient’s torso. For elder patients managing multiple chronic conditions with an array of daily medications, Proteus’ sensors and the app can send alerts to patients as well as family and primary care providers when a key dose has been missed. Trials have shown that Proteus’ system has shown reductions in blood pressure among patients taking medication for hypertension.
From these examples, it becomes clearer to see how digital health programs, which can be tailored and optimized for individual patients and delivered at scale via mobile, represent a transformational development in healthcare. As Andreessen Horowitz partner Vijay Pande calls it, digital therapeutics, by enabling the kind of behavioral meditation which is the only effective way of managing chronic illness, represent a true “third phase” of medicine, after small-molecule drugs and protein biologics. I predict that someday, apps that help people manage illness and prevent long-term disease will no longer have a special name. They will just be another form of software on our phones. More than anything else, the rise of digital therapeutics demonstrates once again the power of mobile computing as the most transformational technology platform the world has ever seen.