An antipsychotic drug that is said to have fewer side effects than commonly-used medication has received marketing authorisation from the European Commission.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a Positive Opinion for Latuda (lurasidone) on January 23.
Latuda has already been approved to treat schizophrenia in the US, Canada, Switzerland and Australia.
The Marketing Authorisation for Latuda was based on a comprehensive clinical trial programme of eight positive studies, which included placebo and active comparators. The review also covered more than 50 clinical trials and more than 4,500 Latuda-treated subjects. Latuda was shown to be effective in treating positive and negative symptoms in acutely psychotic patients with schizophrenia (Nakamura et al, 2009; Nasrallah et al, 2013; Meltzer et al, 2011; Loebel et al, 2013; Ogasa et al, 2013).
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 (Company Core Data Sheet, 2013) In short and long-term clinical studies, Latuda has demonstrated effectiveness with low rates of metabolic change (Meltzer et al, 2011, Loebel et al, 2013; Citrome et al, 2012).
Latuda demonstrated significant reductions in mean weight and BMI over 12 months in contrast to increases in risperidone-treated patients (Citrome et al, 2012). In separate studies, Latuda demonstrated significant reduction in clinically significant weight gain (≥ 7%) compared to quetiapine XR over 12 months (Loebel et al, 2013), and patients switching from olanzapine to Latuda experienced mean weight loss during the subsequent 6 months (Stahl et al, 2013)
“When treating schizophrenia, it’s important to balance efficacy with tolerability, especially as weight gain can have such a negative impact on physical health and is a common reason why people fail to adhere to treatment,” said Professor Tony Hale, medical director, CNS, at Sunovion Pharmaceuticals Europe Ltd, which will market Latuda in the UK. “Additional treatment options that can provide symptom control with minimal metabolic effects would be of value to both patients and their physicians.”
Naoki Noguchi, vice president, commercial operations at Sunovion, added: “We believe this important decision will help support an area in urgent need of additional treatment options for patients and healthcare professionals.”
Latuda is expected to be launched in the UK in the third quarter of 2014.
Citrome L et al (2012) Long-term safety and tolerability of lurasidone in schizophrenia: a 12-month, double-blind, active-controlled study. International Clinical Psychopharmacology 27 165–76.
Company Core Data Sheet/ Swiss SmPC, June 2013.
Loebel A et al (2013) Efficacy and safety of lurasidone 80mg/day and 160mg/day in the treatment of schizophrenia: A randomized, double-blind, placebo- and active-controlled trial. Schizophrenia Research. 145(1–3) 101–9.
Loebel A et al (2013) Effectiveness of lurasidone vs. quetiapine XR for relapse prevention in schizophrenia: A 12-month, double-blind, noninferiority study. Schizophrenia Research 147 95-102.
Meltzer H et al (2011) Lurasidone in the Treatment of Schizophrenia: A Randomized, Double-Blind, Placebo- and Olanzapine-Controlled Study. American Journal of Psychiatry 168 957–67.
Nakamura M et al (2009) Lurasidone in the treatment of acute schizophrenia: a double-blind, placebo-controlled trial. Journal of Clinical Psychiatry 70 829–36.
Nasrallah H et al (2013) Lurasidone for the treatment of acutely psychotic patients with schizophrenia: A 6-week, randomized, placebo-controlled study. Journal of Psychiatric Research 47(5) 670–7.
Ogasa M et al (2013) Lurasidone in the treatment of schizophrenia: a 6-week placebo-controlled study. Psychopharmacol [Berl] 225(3) 519–30.
Stahl SM et al (2013) Effectiveness of lurasidone for patients with schizophrenia following 6 weeks of acute treatment with lurasidone, olanzapine, or placebo: a 6-month, open-label, extension study. Journal of Clinical Psychiatry 74(5) 507-15.