Schizophrenia patients in the United States now have a new treatment option. Intra-Cellular Therapies has just announced that their investigative therapy called CAPLYTA has received FDA approval for adult schizophrenia patients at a 42/mg per day dose.
The therapy is an oral medication taken once each day that researchers believe could significantly improve patients’ quality of life.
Currently, many schizophrenia patients end up discontinuing their treatment because of negative side effects such as the development of movement disorders and weight gain. When untreated however, the symptoms of the condition can also be devastating. These may include hallucinations, delusions, depression, declining social functioning, cognitive disability, and others. It is clear that a new treatment was needed.
FDA’s approval for CAPLYTA came from two different clinical trials. Both showed efficacy in comparison to placebo for the primary endpoint: Positive and Negative Syndrome Scale score.
Short term data showed similar changes from the baseline for fasting glucose, total cholesterol, triglycerides, and weight gain between the treatment and placebo.
The most common AEs documented for CAPLYTA were dry mouth and somnolence.
Interestingly, researchers aren’t quite sure what the mechanism of action is for CAPLYTA.
Intra-Cellular is planning their commercial launch for this new therapy by the end of the first quarter of 2020.
This new treatments evidence of safety and efficacy are bringing a lot of hope to this patient community. When patients receive effective treatment quickly, their lives may be significantly improved at a faster rate.
Now, Intra-Cellular is working to see if the therapy may be effective for other conditions such as Alzheimer’s disease, dementia, depression, bipolar depression, and other neurological conditions. Hopefully, safety and efficacy will be demonstrated in these areas as well.
You can read more about this therapy here.