Novartis launches schizophrenia treatment Fanapt in the US, offering patients an attractive alternative to existing medications

Fanapt proven effective for the acute treatment of schizophrenia in adults

13-Jan-2010 - Switzerland

Novartis announced that Fanapt(TM) (iloperidone) tablets are now available for use across the US for the acute treatment of schizophrenia in adults. Fanapt is a twice-daily, oral antipsychotic, approved by the US Food and Drug Administration (FDA) in May 2009.

Fanapt is indicated for the acute treatment of schizophrenia in adults. In clinical trials, treatment with Fanapt resulted in significant 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 24 mg per day. As many as 87% of patients taking Fanapt did not experience weight gain >= 7% of body weight in clinical trials (88% for 10-16 mg doses; 82% for 20-24 mg 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 2.1 kg or less than five lbs. Additionally, patients did not experience medically important changes in triglyceride and total cholesterol measurements. Fanapt also demonstrated a low incidence that was similar to placebo of the following extrapyramidal symptoms: parkinsonism, dystonia, dyskinesia and bradykinesia.

"Individuals with schizophrenia face enormous challenges, and while there is no cure, it can be a manageable illness when a patient has the right medication," said Dr. Peter Weiden, MD, Director of the Psychotic Disorders Program and Professor of Psychiatry at the University of Illinois at Chicago. "It is important to have a therapeutic option like Fanapt that can manage symptoms and enable functioning with a rate of akathisia no higher than placebo and without medically relevant changes in triglycerides and total cholesterol levels."

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