Vanda Pharmaceuticals Inc announced that the US Food and Drug Administration (FDA) has granted marketing approval of Fanapt (iloperidone) for the acute treatment of adult patients with schizophrenia. 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.
Fanapt is a mixed dopamine D2/serotonin 5HT2A receptor antagonist, and belongs to the class of atypical anti-psychotics.
"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 Programme 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 12 mg to 24 mg per day. The recommended target dose range of Fanapt is 12 mg to 24 mg per day. Titration to the target dose of 12 mg per day can be achieved in four 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 Behaviour 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."
"The approval of Fanapt by the FDA represents many years of tireless efforts by current and former colleagues, many investigators and thousands of patients who participated in the development of this new treatment for schizophrenia. I would like to extend my gratitude to all those who contributed and reaffirm the commitment of Vanda Pharmaceuticals to the discovery and development of medicines for those in need," said Mihael H Polymeropoulos, Vanda's chief executive officer.
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), the 24 mg/day Fanapt dose was superior to placebo in the Positive and Negative Syndrome Scale (PANSS) total score.
In a six-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.
Vanda Pharma is a biopharmaceutical company focused on the development and commercialization of clinical-stage products for central nervous system disorders.