The news: Digital therapeutics (DTx) company Happify Health is developing a prescription digital therapy to treat migraines, following a pilot study of 5,000 migraine sufferers.

Key findings:

• Nearly 18% of migraine sufferers who completed more than two of Happify’s migraine assessments reported improvement in migraine frequency and a reduction in stress.
• And 12% of participants reported improvements in pain.

The opportunity: There’s a massive and growing addressable market of migraine sufferers—some of whom are averse to using traditional meds.

• Nearly 25% of US households include an individual suffering from a migraine, per Migraine Research Foundation data—a figure which has likely worsened since the onset of COVID-19.
• About 60% of migraine patients report the frequency of their migraines increased due to factors like stress and disruption in sleep habits, according to a September 2020 study.

And there’s an even larger opportunity among pediatric patients, especially since parents of these patients are likely seeking safer, medication alternatives:

• Approximately 10% of the child US population experiences migraines, per the Migraine Research Foundation.
• Some DTx players have already ventured into the pediatric market: DTx developer Theranica markets its chronic migraine treatment to kids 12 or older, for instance.

Why it will succeed: Digital therapy devs like Happify Health will have to earn the FDA’s stamp of approval to boost the chances that consumers and clients like employers trust and adopt their tools.

Getting FDA clearance likely won’t be a massive challenge for Happify Health:

• Earlier this year, head of DTx at Happify Health, Chris Wasden, told Insider Intelligence that “The second easiest stakeholder to convince, and this may be surprising, is the FDA...as long as you meet with the FDA and meet their requirements, you can get your product cleared by them. Or you can not get it cleared, but still be regulated by them.”

Companies like Happify Health could get new employer clients on board with FDA clearance, given migraines are likely affecting workers’ productivity:

• More than half of US individuals say they miss work or school due to migraines and headaches.
• What’s more, only 42% of employees actually inform their employers of their migraines, according to the Migraine Research Foundation.

Dig deeper: To learn more about barriers to digital therapeutics adoption, check out our Q&A with Chris Wasden, the Head of DTx at Happify Health.