Officials with the FDA have approved a supplemental new drug application (sNDA) to expand the use of lurasidone HCl (Latuda, Sunovion) to include the treatment of bipolar depression in pediatric patients (10 to 17 years of age).
Officials with the FDA have approved a supplemental new drug application (sNDA) to expand the use of lurasidone HCl (Latuda, Sunovion) to include the treatment of bipolar depression in pediatric patients (10 to 17 years of age), according to a press release. It is the first single-agent formulation to receive approval for this pediatric indication.
Lurasidone HCl is currently approved for the treatment of adults with bipolar depression as monotherapy and adjunctive therapy with lithium or valproate, as well as for the treatment of adolescents aged 13 to 17 years old and adults with schizophrenia.
The sNDA approval is based on data from a phase 3 6-week clinical study including 347 children and adolescents with bipolar depression who received once-daily of lurasidone HCl flexibly dosed (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.
According to the press release, long-term use (more than 6 weeks) of lurasidone HCl has not been established in controlled studies. Health care providers should reevaluate the long-term usefulness of the treatment for the individual patient. Efficacy of lurasidone HCl for the treatment of mania associated with bipolar disorder has not been established.
Lurasidone HCl was generally well-tolerated in study participants. The most common adverse effects associated with treatment were nausea, weight gain, and insomnia.
Lurasidone HCl is available in 5 tablet strengths: 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg.
Sunovion Receives FDA Approval of Supplemental New Drug Application (sNDA) for the Use of Latuda (Lurasidone HCl) in the Treatment of Bipolar Depression in Pediatric Patients (10 to 17 Years of Age) [news release]. Sunovion’s website. http://news.sunovion.com/press-release/sunovion-receives-fda-approval-supplemental-new-drug-application-snda-use-latuda. Accessed March 7, 2018.