The U.S. Food and Drug Administration (FDA) yesterday approved a new psychiatric medication for the treatment of adults with schizophrenia called Fanapt (iloperidone).
Fanapt (iloperidone) is a mixed dopamine D2 / serotonin 5HT2A receptor antagonist, and belongs to the class of atypical antipsychotics. It is manufactured by Vanda Pharmaceuticals Inc.
The approval was supported by two placebo-controlled Phase III 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.
“Having Fanapt available is a major help for our patients in offering an effective antipsychotic with an excellent side effect profile across a wide range of major tolerability problems associated with other antipsychotic therapies.”
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 DSM-III/IV criteria for schizophrenia, and Fanapt was shown to be superior to placebo in controlling symptoms of schizophrenia across doses of 12mg to 24mg per day.
The recommended target dose range of Fanapt is 12mg to 24mg per day. Titration to the target dose of 12mg per day can be achieved in 4 days.
Vanda plans to make Fanapt available in pharmacies later this year.
“Fanapt is an important option for psychiatrists in treating patients with schizophrenia. It is an effective antipsychotic with excellent tolerability,” added Dr. Steven G. Potkin Professor of Psychiatry and Human Behavior at the University of California at Irvine.
“We also look forward to Vanda’s continuing development of long-acting formulations of Fanapt, to further address the significant unmet medical issues in this population of patients.”
In a 4-week placebo-controlled trial (n=604) involving one fixed dose of Fanapt (24 mg/day) compared to placebo and an active control (Geodon(R)), the 24 mg/day Fanapt™ dose was superior to placebo in the Positive and Negative Syndrome Scale (PANSS) total score.
In a 6-week placebo-controlled trial (n=706) involving two dose ranges of Fanapt (12-16 mg/day and 20-24 mg/day) compared to placebo and an active control (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, orthostatic hypotension, somnolence, tachycardia, and weight increased.
Weight gain was mild, and the overall mean weight increase across all short- and long-term studies was 2.1 kg. Fanapt 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 that are 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.
Source: Vanda Pharmaceutical press release