21 May 2013 - 21 May 2013 - US-based Sunovion Pharmaceuticals, specialising in drug development for respiratory and central nervous system (CNS) disorders, reported Monday positive results from two pivotal trials of its atypical antipsychotic agent, Latuda (lurasidone HCl), in patients with depressive episodes related to bipolar I disorder.

The six-week, randomised, double-blind, placebo-controlled studies, dubbed PREVAIL 2 and PREVAIL 1, assessed the efficacy and safety of Latuda as monotherapy (20-60 mg/day or 80-120 mg/day vs. placebo, N=505) or adjunctive therapy (20-120 mg/day, N=348) to lithium or valproate, respectively, in patients with bipolar depression, with or without rapid cycling (DSM-IV-TR). The studies also evaluated changes from baseline to week six in metabolic parameters, including lipids, glucose, weight, insulin and homeostatic model assessment of insulin resistance.

The results demonstrated that the drug, either as monotherapy or added to ongoing treatment with lithium or valproate, was related to low rates of change in weight, body mass index (BMI), lipid parameters and measures of glycemic control.

The most common side effects from both studies included nausea, somnolence, tremor, akathisia, insomnia, headache and sedation.

In late 2012, the US drug regulator FDA accepted two supplemental New Drug Applications (sNDAs) for the use of Latuda as a monotherapy and adjunctive therapy to lithium or valproate in bipolar depression.

The product was approved in the USA as a therapy of adult patients with schizophrenia in October 2010.