Recently, FDA has approved lurasidone HCl for the treatment of bipolar depression in pediatric patients (10 to 17 years of age). It is the first of its kind formulation to receive approval for this pediatric indication. Currently, it is approved for the treatment of adults with bipolar depression as monotherapy and in combination therapy with lithium or valproate, as well as for the treatment of adolescents aged 13 to 17 years old and adults with schizophrenia.
The approval is based on data from a phase 3 6-week clinical study including 347 children and adolescents with bipolar depression who received a once-daily dose of lurasidone HCl (20-80 mg/day) or a placebo. Treatment with lurasidone HCl demonstrated statistically significant and clinically meaningful improvement in bipolar depression symptoms compared to placebo. Lurasidone HCl is available in 5 tablet strengths: 20 mg, 40 mg,…
