In clinical trials, treatment with Fanapt resulted in improvement in symptoms of schizophrenia compared to patients on placebo, as demonstrated on two major scales for measuring the positive and negative symptoms of the disorder.
The most common adverse drug reactions were dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, somnolence, tachycardia, and weight gain. In clinical trials, discontinuation rates due to side effects for patients on Fanapt and on placebo were similar. The incidence of akathisia, a feeling of inner restlessness often associated with other antipsychotics, was also shown to be similar between placebo and Fanapt, up to the maximum dose of 24mg per day.
As many as 87% of patients taking Fanapt did not experience weight gain = 7% of body weight in clinical trials (88% for 10-16mg doses; 82% for 20-24mg doses, and 87% for all patients in the trials). Across all short-and-long-term studies, the overall mean weight gain from baseline to end of the trial was 2.1kg or less than five lbs. Additionally, patients did not experience medically important changes in triglyceride and total cholesterol measurements. Fanapt demonstrated a low incidence that was similar to placebo of the following extrapyramidal symptoms: parkinsonism, dystonia, dyskinesia and bradykinesia.
Ludwig Hantson, head of Pharma North America and CEO of Novartis, said: “Schizophrenia remains one of the most debilitating and difficult to treat mental illnesses. The launch of Fanapt is important because there is a need for alternative medications for many individuals who are suffering from this disease. In clinical trials, Fanapt was shown to be effective for the symptoms of schizophrenia. Fanapt also showed a low incidence of certain side effects, and the percentage of patients who discontinued treatment was similar to that of placebo.”