The first new schizophrenia treatment in seven years has been made available in the UK after the Committee for Medicinal Products for Human Use (CHMP) and the Medicines and Healthcare Products Regulatory Agency (MHRA) approved the use of Latuda (lurasidone), a new once-daily oral treatment in adults.
In short and longer-term clinical studies, LATUDA was found to be effective in adult patients with schizophrenia with negligible effects on weight and minimal effects on cardiometabolic parameters, such as glucose and cholesterol.
The treatment is characterised by high-affinity binding for dopamine (D2) and serotonin (5HT2A and 5HT7) receptors. LATUDA has no appreciable affinity for histamine (H1) and muscarinic (M1) receptors. The most common side effects seen in short and long-term studies of LATUDA include insomnia; somnolence; restlessness or akathisia; difficulty moving, slow movements, muscle stiffness or tremor; weight gain and nausea.
Professor David Taylor, Director of Pharmacy and Pathology, South London and Maudsley NHS Foundation Trust said: “The availability of lurasidone in the UK is welcome news for adults with schizophrenia and mental health professionals.
"When treating patients, it is important to find a medication with the right balance between efficacy and tolerability to help improve adherence and ultimately avoid relapse. Lurasidone offers an effective and generally well-tolerated treatment option for adults with schizophrenia."
Patients with schizophrenia have a reduced life span of approximately 10-22.5 years and the leading cause of mortality for people with schizophrenia is cardiovascular disease, with an estimated 25% higher mortality rate versus the general population.
The licensing of LATUDA was based on short and long-term data which found it to be effective in treating both positive and negative symptoms in psychotic patients with schizophrenia.
A post-hoc analysis conducted in one trial found that patients taking LATUDA (37 mg/day and 111 mg/day) were not significantly different from patients taking olanzapine (15 mg/day) in short-term symptom improvements. In a 12-month study, LATUDA (37-148 mg/day) demonstrated non-inferiority in comparison to quetiapine XR (200-800 mg/day) on the primary efficacy endpoint of time to relapse.
“We believe there is an unmet need in the UK for treatments that provide both efficacy and tolerability, so are pleased to offer LATUDA as a new treatment option for people living with schizophrenia and the healthcare professionals who treat them,” said Richard Russell, Executive Vice President of Sunovion Pharmaceuticals.
Prescribing Information at: http://www.sunovion.eu/files/LATUDAPrescribingInformation.pdf