The FDA has granted marketing authorization to CT-132, an adjunctive, prescription digital therapeutic for the preventive treatment of episodic migraine.
The US Food and Drug Administration (FDA) has granted marketing authorization to CT-132 (Click Therapeutics), an adjunctive, first-in-class prescription digital therapeutic for the preventive treatment of episodic migraine in adults, its development company announced in a statement. The mobile smartphone app uses biological, psychologic, and behavioral approaches to target pain processing and includes such tools as an eDiary tracker and short daily lessons. It is intended for use alongside other acute and preventive treatments for migraine. The marketing authorization, which was reviewed through the FDA's de novo pathway for medical devices, is based on results from two recent clinical trials: the phase 3 ReMMi-D trial and the ReMMiD-C bridging study. As reported…