Novartis announced that Fanapt (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.

"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," said Ludwig Hantson, PhD, Head of Pharma North America, CEO, Novartis Pharmaceuticals Corporation. "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."

Schizophrenia is a chronic, severe and disabling mental disorder, affecting 2.4 million Americans. People with schizophrenia have varying levels of response and tolerance to available therapies. Despite the severe symptoms of this disorder, as many as 74% of all patients discontinue their medication before completing 18 months of treatment, according to a major National Institute of Mental Health (NIMH) study. In a separate trial, more than a quarter of patients changed their medications within a year, with a mean time to switching of 100 days.

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."

Fanapt tablets are indicated for the acute treatment of schizophrenia in adults and belongs to a class of medications for schizophrenia known as atypical antipsychotics.

The FDA approval of Fanapt was supported by two placebo- and active-controlled short-term (4- and 6-week) trials. Safety data was derived from more than 2,000 patients in short- and long-term studies. Both trials enrolled patients who met the DSM-III/IV criteria for schizophrenia. Fanapt was shown to be superior to placebo in controlling symptoms of schizophrenia using the Positive and Negative Symptom Scale (PANSS) and the Brief Psychiatric Rating Scale (BPRS). Efficacy was demonstrated across doses of 12 mg to 24 mg per day - which is the recommended daily target dose range. Fanapt must be titrated slowly from a low starting dose to avoid orthostatic hypotension; titration to the lowest effective dose of 12 mg per day can be achieved in four days with the use of an available titration pack. Fanapt can be administered without regard to meals.

The effectiveness of Fanapt for more than 6 weeks has not been systematically evaluated in clinical trials. Therefore, the physician who elects to use Fanapt for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Novartis has exclusive commercialization rights to the oral formulation of Fanapt in the US and Canada under an agreement with Vanda Pharmaceuticals Inc., as well as exclusive rights to develop and commercialize a long-acting injectable (or "depot") formulation of this medicine for these markets.