Key Highlights
- FDA Breakthrough Device designation awarded to CT-155, a novel prescription digital therapeutic co-developed by Click Therapeutics and Boehringer Ingelheim, aimed at treating schizophrenia’s negative symptoms.
- The designation emphasizes the potential of Digital Therapeutics to revolutionize mental health care, offering a promising new treatment avenue for the 24 million people affected by schizophrenia worldwide.
- CT-155’s development marks significant progress in addressing the profound societal and personal burden of schizophrenia, especially targeting the challenging negative symptoms that current treatments fail to address adequately.
Source: PR Newswire
Notable Quotes
- “We are thrilled to receive this Breakthrough Device designation for CT-155 as it brings us one step closer to being able to provide additional treatment options to those living with schizophrenia, where there remains a significant unmet need due to a lack of access to psychosocial intervention therapies,” – Shaheen Lakhan, MD, PhD, FAAN, Chief Medical Officer at Click Therapeutics
- “This Breakthrough Device designation is an affirmation of the groundbreaking work by the Boehringer Ingelheim and Click Therapeutics teams to advance the standard of care in schizophrenia,” – Austin Speier, Chief Strategy Officer at Click Therapeutics
SoH's Take
This FDA Breakthrough Device designation for Click Therapeutics’ CT-155 represents a significant milestone in the field of Digital Therapeutics and mental health care. It underscores the ongoing commitment to innovation and the potential of digital solutions to transform treatment paradigms. CT-155’s focus on the negative symptoms of schizophrenia, often the most debilitating and less addressed aspect of the condition, offers hope and highlights the importance of holistic and innovative care approaches. As the healthcare industry continues to evolve, embracing such cutting-edge technologies will be pivotal in addressing complex, chronic conditions like schizophrenia, thus improving patient outcomes and quality of life. This is a step forward in the right direction, promising a future where digital therapeutics stand as a vital component of healthcare strategies.
