NEW YORK – December 16, 2022 – Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for CT-132. Click’s CT-132 prescription digital therapeutic is under development as an adjunctive preventive treatment for episodic migraine in patients aged 18 years and older.

Migraine is a complex and debilitating condition that affects more than 47 million Americans,¹ and is the second leading cause of years lived with a disability.² For those living with migraine, attacks unfold over hours to days and negatively impact many domains including employment, educational attainment, and relationships.³ Despite its prevalence, migraine remains a disorder with high unmet need due to incomplete remission and lack of access to specialty care.

The Breakthrough Devices Program is intended for devices that have potential to provide for more effective treatment over existing standard of care for life-threatening or irreversibly debilitating diseases. The program is designed to expedite the development and review of medical devices meeting Breakthrough criteria in the United States.

“We are thrilled to receive this Breakthrough designation as it will facilitate collaborative discussions with the FDA and help expedite the process of bringing a first-in-class migraine digital therapeutic to patients,” said Austin Speier, Chief Strategy Officer of Click Therapeutics. “This is also powerful recognition of the innovative work led by our in-house science and development teams to create a new approach to treating migraine, one supported by early, promising clinical data.”

“Breakthrough further affirms that our unique approach to unlock undruggable CNS targets has merit through the combination of digital neuroactivation and modulation (DiNaMo) and neurobehavioral interventions,” said Shaheen Lakhan, MD, PhD, FAAN, Chief Medical Officer of Click Therapeutics. “Through this new paradigm, we aim to restore lives ravaged by debilitating brain diseases like migraine.”

Additionally, the CT-132 program is validated by the active support of Click’s Migraine Advisory Board comprising leading thought-leaders in headache research and clinical care chaired by Stewart Tepper, MD, professor of neurology of Geisel School of Medicine at Dartmouth and director of Dartmouth Headache Center.

Click has completed or initiated three clinical studies on CT-132, leveraging and expanding its proprietary Click Neurobehavioral Intervention (CNI) Platform in the process. When complete, the data from these trials will support the product’s FDA regulatory submission.

Click Therapeutics, Inc. develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. We are expanding the possibilities of medicine with Digital Therapeutics™ that combine clinical science with the power of software to create a new way to treat disease.  

Operating at the intersection of biology and technology, we use a proprietary platform-based approach to therapeutic development that leverages patient-centric design principles and innovative AI-based technologies to deliver a unique combination of engagement and clinical outcomes, consistently. Digital therapeutics on Click’s platform are regulated, clinically validated prescription mobile applications that can address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. 

Click Therapeutics, in collaboration with Otsuka, developed the first prescription digital therapeutic authorized by the FDA for the adjunctive treatment of major depressive disorder symptoms, Rejoyn™. In October 2024, in response to FDA guidance on prescription drug use-related software (PDURS), we launched Click SE™ to extend our digital therapeutics platform and expertise to the development of software-enhanced drug™ therapies that combine software with pharmacotherapy to offer added clinically meaningful benefit to patients.

Our commitment to advancing digital medicine means we continually improve our platform technologies, ensuring we stay at the forefront of cognitive, behavioral, and neuromodulatory therapeutic innovation, to achieve the best possible outcomes for patients. Our diverse team of innovators—spanning clinicians, researchers, technologists, designers and more—works together to create cutting-edge digital therapeutics, united in the mission to transform patient care. For more information, visit www.clicktherapeutics.com and connect with us on LinkedIn.