FDA grants breakthrough device designation to digital therapeutic for schizophrenia

The FDA has granted breakthrough device designation for CT-155, an investigational prescription digital therapeutic co-developed by Click Therapeutics and Boehringer Ingelheim to treat negative symptoms of schizophrenia.

According to a Click press release, CT-155 is a novel software accessible on mobile devices that is being studied as an adjunct to standard of care pharmaceutical therapy for schizophrenia.

Currently available antipsychotic medications for schizophrenia are indicated for positive symptoms, such as hallucinations, disorganized speech and behavior agitation. However, negative symptoms of schizophrenia are strong predictors of cognitive impairment that have not been effectively addressed by the standard of care antipsychotic or other medications, the release stated. There are no approved pharmacotherapies or medical devices available to treat the negative symptoms of schizophrenia, which may improve daily quality of life for affected individuals.

The breakthrough devices program is intended to expedite the development and review of medical devices that may provide more effective treatment than current standards.

“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, said in the release.