Click Therapeutics Inc, a provider of Digital Therapeutics as prescription medical treatments, announces 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.

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.

[Source(s): Click Therapeutics Inc, Business Wire]