Migraine treatment gets breakthrough device designation from FDA

Click Therapeutics announced it has received breakthrough device designation from the FDA for its digital therapeutic, CT-132, as an adjunctive preventive treatment for episodic migraines in those aged 18 years and older.

“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,” Austin Speier, chief strategy officer at Click Therapeutics, said in a press release from the company.

According to the release, CT-132 uses the proprietary Click Neurobehavioral Intervention platform. Click Therapeutics has either completed or initiated three clinical trials for CT-132, which have leveraged and expanded the platform. Following completion, trial data will support the FDA submission.

In addition, the Click Therapeutics’ migraine advisory board has validated the CT-132 program through active support.

“’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,” Click Chief Medical Officer Shaheen Lakhan, MD, PhD, FAAN, said in the release. “Through this new paradigm, we aim to restore lives ravaged by debilitating brain diseases like migraine.”