FDA Approves Vanda Pharmaceuticals’ Fanapt(TM) for the Treatment of Schizophrenia
Fanapt(TM) is a mixed dopamine D2 / serotonin 5HT2A receptor antagonist, and belongs to the class of atypical antipsychotics.
“The approval of Fanapt(TM) 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.
The efficacy of Fanapt(TM) 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(TM) 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(TM) is 12mg to 24 mg per day. Titration to the target dose of 12mg per day can be achieved in 4 days.
Vanda plans to make Fanapt(TM) available in pharmacies later this year.
“Fanapt(TM) 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
“The approval of Fanapt(TM) 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
In a 4-week placebo-controlled trial (n=604) involving one fixed dose of Fanapt(TM) (24 mg/day) compared to placebo and an active control (Geodon(R)), the 24 mg/day Fanapt(TM) 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(TM) (12-16 mg/day and 20-24 mg/day) compared to placebo and an active control (Risperdal(R)), both doses of Fanapt(TM) were superior to placebo on the Brief Psychiatric Rating Scale (BPRS) total score.
While it is not known how long patients treated with Fanapt(TM) 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(TM) was generally well-tolerated and the most commonly observed adverse reactions (incidence >= 5% and two-fold greater than placebo) 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(TM) was not associated with any medically important elevations in glucose, triglycerides or cholesterol. Fanapt(TM) was also associated with only modest elevations of prolactin as compared to larger elevations seen with some other drugs in this class.
Fanapt(TM) 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(TM) may affect heart rhythm parameters and specifically the QTc interval, which may lead physicians to consider prescribing Fanapt(TM) after other antipsychotics are tried first.
Schizophrenia is a chronic debilitating disorder which affects more than two million Americans, and millions more worldwide. While significant progress has been made in understanding the disease and developing treatments, there remains a significant unmet medical need. More than 50% of patients switch their medication in a given year due to either poor response or the experience of adverse events. Worldwide sales from the class of atypical antipsychotics exceeded US
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