Novartis has announced that Fanapt (iloperidone) is now available for use across the U.S. for the acute treatment of schizophrenia in adults.
Fanapt is a twice-daily, oral antipsychotic approved by the FDA in May 2009. It belongs to a class of medications for schizophrenia known as atypical antipsychotics.

"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, Ph.D., CEO of 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 that affects 2.4 million people in the U.S. People with schizophrenia have varying levels of response and tolerance to available therapies. Despite the severe symptoms of this disorder, as many as 74 percent of all patients discontinue their medication before completing 18 months of treatment, according to a major National Institute of Mental Health 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 (when a person's blood pressure suddenly falls when he or she stands up or sits up after reclining), drowsiness, fast heart rate 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 percent of patients taking Fanapt did not experience weight gain greater than or equal to 7 percent of body weight in clinical trials (88 percent for 10 to 16 mg doses, 82 percent for 20 to 24 mg doses and 87 percent for all patients in the trials). Across all short- and long-term studies, the overall mean weight gain from baseline to the end of the trial was less than five pounds. Additionally, patients did not experience medically important changes in triglyceride and total cholesterol measurements.

"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, M.D., 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."

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

Contact:
Michael Billings
862-778-8656
michael.billings@novartis.com