FDA clears Otsuka, Click's prescription app for depression
Otsuka and Click Therapeutics Announce the U.S. Food and Drug Administration (FDA) Clearance of Rejoyn™, the First Prescription Digital Therapeutic Authorized for the Adjunctive Treatment of Major Depressive Disorder (MDD) Symptoms
Click Therapeutics and BI Announce FDA Breakthrough Device Designation
As it builds out a pipeline of digital therapeutics spanning a wide range of conditions—from smoking cessation to depression to schizophrenia—Click Therapeutics has made a habit of turning to the experts in those treatment areas for help.
Click Therapeutics Announces Participation in Upcoming Technology and Biotechnology Investor Events
NEW YORK--(BUSINESS WIRE)--Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced the initiation of the CONVOKE Study, a registrational clinical trial to investigate the use of prescription digital therapeutics as an adjunct treatment to standard of care antipsychotic therapy to treat the negative symptoms of schizophrenia in patients 18 years and older. The pivotal, randomized, multi-site trial will enroll approximately 432 patients nationwide. The study intervention period will be 16 weeks and efficacy will be assessed by the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure scale (CAINS-MAP). The CAINS-MAP measures experiential negative symptoms, the clinical target of interest in the evaluation of efficacy in this study. The CAINS was developed and validated with National Institute of Mental Health (NIMH) funding in response to the limitations of existing treatment and assessment approaches to negative symptoms identified at the NIMH-MATRICS Consensus conference in 2005.1
A yearslong collaboration between Click Therapeutics and drugmaker Boehringer Ingelheim exploring the potential of digital apps in schizophrenia therapy will now be put to the test in the clinic.
Click Therapeutics to Present at the 22nd Annual Needham Virtual Healthcare Conference
NEW YORK--(BUSINESS WIRE)--Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today shared multiple accomplishments and advances in its research and development (R&D) programs. Over the past year, Click has broadened and accelerated its digital therapeutic R&D programs, supporting initiation or completion of 10 clinical trials across 9 therapeutic areas including neurology, oncology, inflammatory disease and serious mental illness. In sum, Click has enrolled more than 1,000 patients in early and late stage studies. Click’s R&D efforts represent a continued commitment to building prescription digital therapeutics that integrate clinical science with patient-centric design to build efficacious and engaging treatments in therapeutic areas with high unmet need, combined with the rigors of traditional therapeutic development. Highlights from the year include:
Boehringer Ingelheim inked a massive collaboration with digital therapeutics company Click Therapeutics two years ago — and now its expanding.