(dailyRx News) Vanda Pharmaceuticals Inc. has announced that the FDA has approved Fanapt (iloperidone) for the acute treatment of adult patients with schizophrenia.
Fanapt is an atypical antipsychotic. Its approval was supported by two placebo-controlled phase 3 clinical studies comparing Fanapt to placebo and active control in patients with schizophrenia, as well as safety data from more than 3,000 patients.
"The approval of Fanapt marks a new opportunity for many patients with schizophrenia, who experience only partial responses to current therapies, to achieve better control of their symptoms," remarked Dr. Peter J. Weiden, professor of psychiatry and director of the Psychotic Disorders Program at the University of Illinois at Chicago.
The efficacy of Fanapt for the treatment of schizophrenia was supported by two placebo-controlled, short-term (4- and 6-week) trials. Both trials enrolled patients who met the criteria for schizophrenia, and Fanapt was shown to be superior to placebo in controlling symptoms of schizophrenia at doses of 12 mg to 24 mg per day, the recommended target dose range. Titration to the target dose of 12 mg per day can be achieved in four days.
In the 4-week placebo-controlled trial involving one fixed dose of Fanapt (24 mg/day) compared to placebo and an active control (ziprasidone, brand name Geodon), the 24 mg/day Fanapt dose was superior to placebo in the Positive and Negative Syndrome Scale (PANSS) total score.
In the 6-week placebo-controlled trial involving two dose ranges of Fanapt (12 to 16 mg/day and 20 to 24 mg/day) compared to placebo and an active control (risperidone, brand name Risperdal), both doses of Fanapt were superior to placebo on the Brief Psychiatric Rating Scale (BPRS) total score.
While it is not known how long patients treated with Fanapt should be maintained on treatment, it is generally recommended that responding patients be continued beyond the acute response. Patients should be periodically reassessed to determine the need for maintenance treatment.
Fanapt was generally well-tolerated and the most commonly observed adverse reactions were dizziness, dry mouth, fatigue, nasal congestion, dizzy spells on rising due to low blood pressure, drowsiness, tachycardia and weight gain. The weight gain was mild, and the overall mean weight increase across all short- and long-term studies was 2.1 kg.
The drug was not associated with any medically important elevations in glucose, triglycerides or cholesterol. Fanapt was also associated with only modest elevations of prolactin as compared to larger elevations seen with some other drugs in this class.
Fanapt has a low incidence of extrapyramidal symptoms (movement disorders and tremors) and a placebo-like rate of akathisia (restlessness, inability to sit still), which are adverse events often associated with some other drugs in the class of atypical antipsychotics.
Similarly to some other drugs in this class, Fanapt may affect heart rhythm parameters and specifically the QTc interval, which may lead physicians to consider prescribing Fanapt after other antipsychotics are tried first.