For the more than 37 million Americans who suffer from migraines, the FDA authorization of Click Therapeutics’ CT-132—the first prescription digital therapeutic for the preventive treatment of episodic migraine—is more than a headline. It offers the potential for expanded access, improved quality of life, and the legitimization of digital medicine as a cornerstone of care.

Rewriting the Migraine Narrative

For people living with episodic migraine—those experiencing up to 14 migraine days a month—prevention is critical. Migraine is far more than “just a headache.” It is a neurological disease that can be disabling, impacting work, relationships, and emotional well-being.

According to the American Migraine Foundation, almost 90 percent of people with migraines are unable to work or function normally during an attack. What’s more, only about 12 percent of those with migraines receive preventive treatment—a treatment gap due to side effects, fear, access barriers, or lack of awareness.

“This is where CT-132 emerges as a potential game-changer,” said Click Therapeutics Founder and CEO David Klein in an exclusive comment to Medika Life.  “We’re entering a new era of migraine care—where doctors can harness the power of both proven medicines and clinically validated digital therapeutics to meet patients’ urgent needs.”

Data That Delivers

Until recently, the FDA approved most digital health approaches under the device 510K pathway with limited clinical data.  FDA marketing authorization for CT-132 was supported by biopharma-like data from the pivotal ReMMi-D randomized controlled trial, in which CT-132 met its primary endpoint by significantly reducing monthly migraine days on top of background pharmacotherapy,

In the bridging study, ReMMiD-C, CT-132 showed similar performance in patients on prescription calcitonin gene-related peptide (CGRP) inhibitors such as Aimovig (erenumab), Ajovy (fremanezumab), Emgality (galcanezumab), Vyepti (eptinezumab), Ubrelvy (ubrogepant), Nurtec ODT (rimegepant), and Qulipta (atogepant).  CT-132 is an adjunctive treatment to medication, giving it broad potential use.

CT-132, delivered via a mobile app, achieved statistically and clinically meaningful results in the ReMMi-D pivotal trial. Participants who used the digital therapeutic reported a mean reduction of 3.04 monthly migraine days, compared to just 0.9 days in the sham group (p=0.005). That means real days—at work, with family, outside in the sun—returned to people’s lives.

In a condition where every single migraine-free day matters, the ability to deliver those gains without pharmacological side effects through a smartphone app democratizes access to care. It opens the door to new options, particularly for those who cannot tolerate or access traditional therapies.

“This marks a significant milestone for the more than 37 million adults in the US who live with migraine,” said Shaheen Lakhan, MD, PhD, FAAN, Chief Medical Officer of Click Therapeutics. “CT-132 offers eligible patients a new path to reducing the burden caused by migraine—one they can access anywhere via an evidence-based mobile application on their smartphone.”

Digital Care, Doctor-Led

Importantly, CT-132 does not sideline clinicians—it includes them as front-and-center leaders in care delivery. As a prescription-only digital therapeutic, CT-132 is designed to be used under the guidance of a health provider, adding a new clinical approach to physician-directed personalized care. It enhances—not replaces—traditional physician-patient relationships by enabling clinically validated, behavior-based treatment delivered consistently between visits.

Neurologists and primary care providers who manage migraines now have an evidence-based, non-drug adjustive approach to care, especially to patients who have tried multiple therapies and continue to have breakthrough episodes.

Data is the Gatekeeper

The approval also signals a broader truth long-awaited in digital health: evidence is everything. As digital therapeutics gain traction, the FDA and the medical community are asking for the same rigor as traditional pharmaceuticals.

“For digital health ventures to gain the confidence of regulators, providers, and patients, clinical validation must be central,” said Julien de Salaberry, CEO of Galen Growth. “This approval is a reminder that digital therapeutics can meet gold-standard evidence expectations—and that’s how they earn a place in modern medicine.”

[See Medika Life special report: Consumer HealthTech: A Data-Driven Evolution in Health Engagement]

According to Galen Growth analytics, only 24 percent of digital health companies globally have demonstrated clinical strength through trials or peer-reviewed publications. CT-132 stands out and sets the bar. Generating clinical evidence in digital health has become a marker for success. Galien Growth recently published its landmark analysis of digital health and consumer use, which includes the importance of data for product and category progress.

A Future Forward

The approval of CT-132 reflects a movement in medicine, reimagining how we define treatment, access, and wellness. It’s a reminder that innovation is not just about what is possible, more importantly, what is proven. As more digital therapeutics enter the pipeline, the CT-132 journey offers a case study of what it takes to cross the threshold from hope to health reality.

This approval to market brings something invaluable to people with migraines: urgency. The ability to be treated anywhere, on their terms, using science-backed interventions, gives people not just fewer migraines but more voice in their care.

This is not just a regulatory milestone. It’s a human one.

[This article is not sponsored or requested by any company. The author has been covering digital health since 1995 and seeks to highlight sector trends. He maintains editorial independence.]

The post A Digital Turning Point in Migraine Care: CT-132 FDA Approval to Market is a Win for Patients and Proof that Clinical Evidence Matters appeared first on Medika Life.

Along that difficult road is support – a place of respite from the complex environment innovators face – the community of HITLAB, the Health Innovation Technology Lab.  HITLAB is a leading academic research institution focused on improving global healthcare through innovation and technology and housed within Columbia University in New York City and Chaired by Stan Kachnowski, Ph.D. MPA, HITLAB has become a haven for health, technology, and design champions to find common ground.

“The HITLAB Innovation Summit is a dynamic platform where healthcare leaders, entrepreneurs, and innovators come together to forge groundbreaking solutions,” reflects Dr. Kachnowski.  “It fosters collaboration, sparks creativity, and drives healthcare transformation through the power of technology and innovation.”

HITLAB academic roots at Columbia set a tone for research and training.  New York City has emerged as a hub for digital health innovation. It is home to more and more startups drawing on the resources of the nation’s financial capital, a close connection to academic medical centers and talent. The Big Apple – like Bean Town Boston – is a strategic epicenter to explore how emerging technologies such as augmented intelligence (AI) and virtual reality (VR) find a meeting point with telehealth and remote patient monitoring through rigorous research, analysis, and design thinking.

Centered Around Cutting-Edge Solutions

At its annual HITLAB Innovators Summit 2023, conversations center around cutting-edge solutions for the digital health community to overcome social determinants of health and unite disparate hospitals’ information systems. The gathering is a digital health sector roadmap to advance health access, address challenges, and improve patient outcomes.

Attendees of this intimate Summit that combines keynotes, panel conversations and scheduling networking are fans!

“The HITLAB Innovation Summit is a game-changer for the healthcare industry. The convergence of technology, innovation, and expertise creates an electric environment that fuels groundbreaking ideas and fosters meaningful collaborations,” says John Anderson, chief technology officer HealthTech Innovations.

While other like-forums have evolved into co-counseling sessions on how to survive EHRs and the heavy life to onboard the 500-pound EPIC gorilla, attendees at HITLAB also learn about “EPIC envy” – where small and community health centers that don’t have the resources to afford this state-of-the-art software find alternative paths tapping into technologies to piece together other ways to track patient care and outcomes.

Also, in hearing from major biopharmaceutical companies such as Merck, Novo Nordisk, and others, digital health innovators can reflect on the importance of ample science to shift the conversation from hype to hope and fact-based cautious optimism.  In turn, big pharma share openly on the main stage how science alone – absent of technology – can fall short in meeting patient information, adherence and care needs. 

As in previous years, the HITLAB Innovation Summit 2023 brings together experts across the health innovation ecosystem, including clinical trials, pharma, private equity, public health, engineering, design, and data science. The diverse community is seeking solutions that integrate health tech – digital therapeutics, health information, and smart devices meaningfully. The gathering’s success lies in bridging the gap between patients, payers, product innovators, policymakers and providers. It enables these communities to connect and accelerate practical solutions that can be implemented in real-world settings.

Presenters are Category Leaders

Presenters are bold and blunt. From Bill Taranto, President, Merck Global Health Initiative Fund, to Dr. David Berger, CEO, SUNY Downstate Medical Center, to David Klein, CEO and Co-founder, Click Therapeutics, to Tim McCarthy, Head of Digital Sciences & Translational Imaging, Pfizer and representatives from public health, venture capital finance, legal and regulatory; the three-day gathering offers a bolus of category knowledge.

“The time is now for this space – a revolution in medicine is about to happen that will shift care to center around patients,” emphasizes Click Founder and CEO David Klein. 

Klein was among the key voices discussing integrating therapeutic choices and that physicians would look more holistically in treating patients with drugs, digital therapeutics and behavioral guidance – focusing on people care satisfaction.  Digital therapeutics must model its efforts akin to biotechnology driven by evidence-based clinical outcomes looking beyond the 510K regulatory milestone for approval.

Actionable Insights

The insights shared will guide business planning decisions among newcomers and veterans to the category.  Among the noted attendees at this year’s HITLAB Innovation Summit is Amir Kishon, Ph.D., CEO of Twig Health. Kishon was among the early pioneers in the sector.

“Healthcare as a regulated industry is somewhat apprehensive about innovation. It is in its DNA. Digital health is challenging this predisposition and the question I ask myself is when this industry will tip to appreciate that innovation is a friend. We are getting there,” notes Kishon.

The program conducts studies and clinical trials that set out the scientific methodology to assess digital health interventions’ efficacy, usability, and safety.  It’s now acknowledged that Food and Drug Administration 510K approval to market for digital applications and therapies is a necessary regulatory threshold; the barrier to success is convincing science as a solid foundation for access that requires payer and provider support and a clear pathway to reimbursement.

Bottomline – it’s about reimbursement and ease of use. In the session What’s Needed for Sustainable Adoption of Digital Health American Medical Association Vice President for Digital Health Strategy, Meg Baron, offered very clear insight into how digital health enterprises can better integrate into the physician’s workflow – the “return on health” to show value.

Beyond the Summit, HITLAB promotes entrepreneurship and innovation in the digital health space. HITLAB is multi-faceted – professional development, accelerator and crowd-sources community for startups and early-stage companies, helping them navigate the complex healthcare landscape, access funding opportunities, and refine their product or service offerings.

In incubating promising ideas, HITLAB fuels the growth of the digital health ecosystem, fostering the development of transformative solutions that address unmet needs and drive positive change. Put the fall meeting on your calendars!

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