Dainippon Sumitomo Pharma Co., Ltd. (DSP) and Takeda Pharmaceutical Company Limited have received the positive opinion from the Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMA), for lurasidone for the treatment of schizophrenia in adults.

Lurasidone is a once-daily oral treatment that is currently available in Switzerland, the United States and Canada having been approved for use by the respective regulatory authorities.

The positive CHMP opinion was based on a comprehensive clinical trial programme which included placebo and active comparators. Lurasidone was shown to be  effective in treating both positive and negative symptoms in acutely psychotic patients with schizophrenia over six weeks.

In short and longer term clinical studies, lurasidone has demonstrated effectiveness with low rates of metabolic change. It is  important to minimize the adverse effect of treatments on long-term physical health as patients are likely to remain on therapy for many years.

Lurasidone was generally well-tolerated and had low rates of weight increase, as well as lipid and glucose disturbance, in the treatment of patients with schizophrenia. The most frequent adverse reactions seen in short-term clinical studies (incidence = 5% and at least twice as frequent as with placebo) were somnolence, akathisia, nausea, Parkinsonism and dystonia.

"As a practicing psychiatrist, I am interested in new, effective agents for the treatment of severely ill patients with mental disorders. We need effective, well-tolerated and metabolically neutral treatment alternatives. Lurasidone has an interesting profile, which could benefit many patients with schizophrenia," says Philipp Eich MD, Klinik für Psychiatrie und Psychotherapie, Liestal, Switzerland.

Data for lurasidone was presented at last year’s European College of Neuropsychopharmacology (ECNP) Congress showing lurasidone to have a favourable metabolic side effect profile and to be a welltolerated, efficacious option for patients with schizophrenia switching medication.

Lurasidone is an atypical antipsychotic, developed originally by DSP with a high affinity for dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it has antagonistic effects. In addition, lurasidone is a partial agonist at the serotonin 5-HT1A receptor and has no appreciable affinity for histamine or muscarinic receptors. Lurasidone was approved for the treatment of schizophrenia by the United States Food and Drug Administration in October 2010, by Health Canada in June 2012, and by the Swiss Agency for Therapeutic Products in August 2013.

Lurasidone was launched as LATUDA for the treatment of schizophrenia in adults in the United States in February 2011 and in Canada in September 2012 through DSP’s subsidiary Sunovion Pharmaceuticals Inc., and in Switzerland in September 2013 through Takeda. In Japan a phase III  clinical study is underway for the treatment of schizophrenia by DSP. An application has been filed with the Australian Therapeutic Goods Administration for the treatment of patients with schizophrenia,  as well as the Taiwan Food and Drug Administration (TFDA) and further development in the Chinese and Southeast Asian markets is planned.  

DSP defines its corporate mission as “to broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives for people worldwide”.

Takeda is a research-based global company with its main focus on pharmaceuticals and committed to strive towards better health for people worldwide through leading innovation in medicine.