Japanese firms Dainippon Sumitomo Pharma (DSP) and Takeda Pharmaceutical (Takeda) have received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the use of lurasidone in the treatment of adults with schizophrenia.
Schizophrenia is a severe chronic mental condition that can affect both men and women and affected patients will have a lifespan decreased by between ten and 22.5 years compared with the general population.
The once-daily oral treatment lurasidone is currently available in Switzerland, the US and Canada having been approved for use by the respective regulatory authorities.
CHMP’s positive opinion was based on a clinical trial programme that included placebo and active comparators, which lurasidone was shown to be effective in treating both positive and negative symptoms in acutely psychotic patients with schizophrenia over six weeks.
Lurasidone has also showed effectiveness with low-rates of metabolic change in short and longer term clinical trials and the company said it was important to reduce the adverse effect of treatments on long-term physical health as patients are likely to receive therapy for many years.
The drug 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.
Most frequent adverse reactions of lurasidone seen in short-term clinical studies were somnolence, akathisia, nausea, Parkinsonism and dystonia.
The drug originally by DSP has 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.
The drug was approved for the treatment of schizophrenia by the US FDA in October 2010, by Health Canada in June 2012 and by the Swiss Agency for Therapeutic Products in August 2013.
DSP’s subsidiary Sunovion Pharmaceuticals has launched lurasidone as ‘LATUDA’ for the treatment of schizophrenia in adults in the US in February 2011 and in Canada in September 2012, while in Switzerland the drug was launched in September 2013 by Takeda.
Image: Functional magnetic resonance imaging (fMRI) and other brain imaging technologies allow for the study of differences in brain activity in people diagnosed with schizophrenia. Photo: courtesy of Kim J, Matthews NL, Park S.