Click wins FDA breakthrough designation for prescription digital ...

Click wins FDA breakthrough designation for prescription digital ... unknown

This audio is auto-generated. Please let us know if you have feedback.

Dive Brief:

• Click Therapeutics has received breakthrough device status for its prescription digital migraine therapy.
• The Food and Drug Administration granted the designation to Click’s CT-132 as an adjunctive preventive treatment for episodic migraine in adults, given that many patients have difficulty accessing specialty care or experience incomplete remission. The designation should help expedite the development and review of Click’s device.
• Click sees a significant commercial opportunity for CT-132, pointing to studies that show migraine affects more than 47 million Americans and is the second leading cause of years lived with a disability.

Dive Insight:

The unmet need in migraine has led digital health companies to tackle treatment and prevention from multiple angles. Early last year, the FDA cleared Theranica’s smartphone-controlled prescription wearable device for use as an acute migraine treatment. Separately, Perfood has developed an app to prevent migraines by providing users with an individualized low-glycemic diet.

Click is applying the patient engagement platform behind products such as its nonprescription smoking cessation therapy to migraine. For now, Click is saying little about the migraine product, only revealing that the candidate “combines multiple clinically-validated mechanisms of action” with its platform “to reduce the number of migraines per month in patients with four or more migraine days per month.”

In a statement, Dr. Shaheen Lakhan, chief medical officer of Click, framed the FDA breakthrough designation as evidence of the potential of the platform to address health needs that cannot be met using pharmacological medicines.

“Breakthrough further affirms that our unique approach to unlock undruggable CNS targets has merit through the combination of digital neuroactivation and modulation and neurobehavioral interventions. Through this new paradigm, we aim to restore lives ravaged by debilitating brain diseases like migraine,” Lakhan said.

Click has initiated three clinical studies of CT-132. When complete, the clinical trial program will provide Click with data to include in its regulatory submission to the FDA.