What You Should Know: – Click Therapeutics, Inc. (“Click”), a leader in the rapidly evolving field of prescription medical treatments, encompassing both prescription digital therapeutics (PDTs) and software-enhanced drug™ therapies has received FDA marketing authorization for CT-132, the first prescription digital therapeutic specifically indicated for the preventive treatment of episodic migraine in adults aged 18 and older.– The FDA granted a De Novo Classification Request for CT-132, signifying the novel nature of this digital intervention. This PDT is intended for adjunctive use alongside existing acute and/or other preventive migraine treatments, offering patients an additional tool in their management strategy.CT-132 Prescription Digital TherapeuticThe CT-132 prescription digital therapeutic is indicated for the preventive treatment of episodic migraine in patients 18 years of age and older. It is intended for adjunctive use alongside acute and / or other preventive treatments for migraine. The FDA’s decision was primarily based on compelling data from the pivotal ReMMi-D (Reduction in Monthly Migraine Days, NCT05853900) study. This study evaluated CT-132 in patients already taking standard-of-care prescription migraine medications (including acute, first-line preventive, and second-line preventive treatments) and successfully met its primary endpoint of significantly reducing monthly migraine days.ReMMi-D and ReMMiD-C StudiesFurther supporting the authorization were results from the ReMMiD-C bridging study (NCT06004388)

Dassault Systèmes (Euronext Paris: FR0014003TT8, DSY.PA) today announced its investment in Click Therapeutics, a leader in prescription digital therapeutics ...