" class="no-js "lang="en-US"> Click Therapeutics Receives FDA Breakthrough Device Designation for Prescription Digital Therapeutic to Treat Episodic Migraine - Medtech Alert
Tuesday, May 28, 2024

Click Therapeutics Receives FDA Breakthrough Device Designation for Prescription Digital Therapeutic to Treat Episodic Migraine

Click Therapeutics, a leader in Digital Therapeutics™ as prescription medical treatments, has announced today that it has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for CT-132. Click Therapeutic’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 and is the second leading cause of years lived with a disability. For those living with migraine, attacks unfold over hours to days and negatively impact many domains including employment, educational attainment, and relationships. 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 the 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.”

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