Lurasidone approved for Bipolar Depression in children by FDA

The US Food and Drug Administration (FDA) has approved a supplemental new drug application for lurasidone (Latuda, Sunovion Pharmaceuticals Inc), a serotonin-dopamine antagonist, for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression) in children and adolescents aged 10 to 17 years.

Lurasidone is already approved for Bipolar Depression as Monotherapy and is Indicated as monotherapy for adults with major depressive episode associated with bipolar I disorder (bipolar depression).It is given in 20 mg per day initially; may increase the dose if needed, not to exceed 120 mg/day.However, in monotherapy study, higher dose range (80-120 mg/day) did not provide additional efficacy compared to the lower dose range (20-60 mg/day).

Lurasidone is an atypical antipsychotic indicated for the treatment of:

• Schizophrenia in adults and adolescents (13 to 17 years)


• Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy


• Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults as adjunctive therapy with lithium or valproate

DOSAGE AND ADMINISTRATION-
Lurasidone should be taken with food (at least 350 calories). Administration with food substantially increases the absorption of LATUDA.
Indication Starting Dose Recommended Dose
Schizophrenia – adults
40 mg per day 40 mg to 160 mg per day
Schizophrenia –adolescents (13 to 17 years)
40 mg per day 40 mg to 80 mg per day
Bipolar Depression -
adults (2.2) 20 mg per day 20 mg to 120 mg per day
Bipolar Depression –
pediatric patients (10 to 17 years)
20 mg per day 20 mg to 80 mg per day

Commonly observed adverse reactions (incidence ≥ 5% and at least twice the rate for placebo) were (6.1):

• Adult patients with schizophrenia: somnolence, akathisia, extrapyramidal symptoms, and nausea


• Adolescent patients (13-17 years) with schizophrenia: somnolence, nausea, akathisia, EPS (non-akathisia), rhinitis (80mg only), and vomiting


• Adult patients with bipolar depression: akathisia, extrapyramidal symptoms, and somnolence


• Pediatric patients (10-17 years) with bipolar depression: nausea, weight increase, and insomnia.