• Over 45 million Americans aged 18 years or older report having a migraine or severe headache in the last 3 months, according to the CDC.
• Migraines cost the United States $36 billion annually(1).
• In an observational study with migraine sufferers, Happify showed positive impact on mental wellbeing, quality of life, migraine pain and frequency

Today, Happify Health (www.HappifyHealth.com), a global leader in digital therapeutics for anxiety and depression, announced plans to develop a prescription digital therapeutic (PDT) for the treatment of migraines, following positive results from a pilot study of 5,000 migraine sufferers who used a Happify digital therapeutic.

The study found that in addition to improving the mental wellbeing of migraine patients, Happify helped people manage the negative effects of migraines. Importantly, the study explored the potential link between mental and physiological symptoms of migraine, and found that for those participants showing the largest improvements in stress, their migraine frequency was also significantly decreased.

Full results are available in a new white paper published by Happify Health and are available online at HappifyHealth.com. Based on these and other results from the pilot study, Happify will begin development of a PDT for use in randomized controlled trials (RCTs) in 2022.

Migraines Prevalence

Migraines are a debilitating form of headache disorder affecting nearly 1 in 6 Americans (1), especially women, people between 25 and 55 years of age, and people from lower socioeconomic backgrounds (2). Most people experience episodic migraines but more than 4 million Americans have 15 or more migraines per month, making it a chronic health problem with significant health implications (3). Many who suffer episodic migraines eventually develop chronic migraine problems (4), and recent data suggest the number of migraine sufferers has doubled during the COVID-19 pandemic (5).

The Cost of Migraines

Migraines are more likely to impact people during their most productive working years, which increases the financial burden of disability claims (6) associated with migraines. Worldwide, migraines are one of the leading causes of disability (7), accounting for nearly 10% of all years of healthy life lost to disability among people ages 15 to 49 (8).

Additional Results of Observational Study of Happify on Migraine Sufferers

Stress is the number one migraine trigger reported by migraine sufferers. Migraine sufferers who completed 2+ migraine assessments reported the following outcomes: (n=652):

• 17.8% reduction in stress.
• 17.6% improvement in migraine frequency.
• 11.93% reported improvement in migraine pain.
• 15.9% improvement in fatigue.
• 12% improvement in migraine pain.
• 71.9% of users also reported noticeable improvement in Quality of Life.

“We’re thrilled with our ability to recruit such a large patient cohort for an observational study, and even more pleased to see strong indicators of positive patient outcomes from that study,” said Murray Zucker, MD, Happify Health’s Chief Medical Officer. “We know Covid has advanced a global mental health crisis, and that the massive increase in reported migraines is a byproduct of this crisis. The promise of technology like this is to give doctors, nurses and pharmaceutical companies more ways to treat patients effectively and drive better health outcomes.”

“We’ve taken a measured, clinical approach to product development here at Happify Health, and the results of our migraine product are simply a further validation of our approach,” said Chris Wasden, Head of Pharma Specialty Solutions and Corporate Strategy, Happify Health. “What this study has shown is that we’re able to effectively recruit patients with chronic health problems, like migraines, and drive consistent engagement with a DTX that is demonstrating positive outcomes. At this stage, with these early results, we’re excited to advance to the next stage of product development and prepare for an RCT in 2022.”

About Happify Health:

Happify Health is a global software-enabled healthcare platform. We design and deploy software to help improve mental health, physical health and well-being. We are creating a future where better health outcomes can be powered by technology—leading to more personalized care that can improve the everyday lives of more people. The Happify Health platform offers a full spectrum of science-backed Digital Therapy and Care Journey solutions for customers and individual end-users; including Wellness, AI-based Coaching, Community, as well as Combination and Prescription Digital Therapeutics.

Our patient solutions are disseminated through unified products and services we deploy for the healthcare ecosystem; including enterprises, employers, health plans, health systems, pharma and medical device manufacturers. Our global platform is available in 10 languages, supports more than 10 chronic conditions, and covers more than 20 million lives. For more information, visit www.happifyhealth.com.

1. Migraine Research Foundation
2. The Prevalence and Impact of Migraine and Severe Headache in the United States: Figures and Trends From Government Health Studies.
3. CDC: QuickStats: Percentage of Adults Who Had a Severe Headache or Migraine in the Past 3 Months
4. Migraine: epidemiology, impact, and risk factors for progression.
5. Economic burden of transformed migraine: results from the American Migraine Prevalence and Prevention (AMPP) Study.
6. Chronic migraine: risk factors, mechanisms and treatment.
7. Impact of coronavirus disease 2019 (COVID-19) pandemic on patients with migraine: a web-based survey study.
8. Lifting The Burden: the Global Campaign against Headache (2020).
9. The global burden of headache: a documentation of headache prevalence and disability worldwide.

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