Click Therapeutics Receives FDA Breakthrough Device Designation for Prescription DTx

Good news for Click Therapeutics. The company has announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for CT-132. 

The CT-132 prescription digital therapeutic is 'under development as an adjunctive preventive treatment for episodic migraine in patients aged 18 years and older'.

As per FDA’s website, the Breakthrough Devices Program is intended for devices that have the potential to provide more effective treatment than the 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 U.S.

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.

Three ongoing 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.

Austin Speier, Chief Strategy Officer of Click Therapeutics said, “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. This is also a 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.”

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