Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) 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 antipsychotics.
“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 24 mg 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.”
“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, MD, Vanda’s Chief Executive Officer.
Source: Vanda Pharmaceuticals, USA