The US Food and Drug Administration (FDA) has approved a supplemental new drug application for lurasidone (Latuda, Sunovion Pharmaceuticals Inc) for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression) in children and adolescents aged 10 to 17 years.
Lurasidone, a serotonin dopamine antagonist, is already approved in the United States for the treatment of adults with bipolar depression as monotherapy and as adjunctive therapy with lithium or valproate, and for the treatment of schizophrenia in adults and children aged 13 to 17 years.
The safety and efficacy of lurasidone for bipolar depression in children aged 10 to 17 years were assessed in a 6-week, randomized, double-blind, placebo-controlled study. A total of 347 participants received once-daily lurasidone (20 to 80 mg/day) or placebo.
Lurasidone was associated with statistically significant and clinically meaningful improvement in symptoms of bipolar depression compared to placebo. The primary efficacy endpoint was change from baseline to week 6 in the total score on the Children’s Depression Rating Scale, Revised (-21.0 vs -15.3; effect size = 0.45; P < .0001), the company said in a news release.
Lurasidone also yielded statistically significant and clinically relevant improvement on the Clinical Global Impression–Bipolar Version, Severity of Illness score (depression), compared to placebo (-1.49 vs. -1.05; effect size = 0.44; P < .0001).
Lurasidone was generally well tolerated. The most common treatment-emergent adverse events (vs placebo) were nausea (16.0% vs 5.8%), weight gain (6.9% vs 1.7%), and insomnia (5.1% vs 2.3%).
“Bipolar disorder is a leading cause of disease burden in the pediatric population both here in the US and across the globe, but unfortunately, few treatments are effective in treating young people living with the condition,” Robert Findling, MD, director of child and adolescent psychiatry, Johns Hopkins University School of Medicine, Baltimore, Maryland, commented in the release.
“We know that children who have been diagnosed with bipolar depression can be at risk for poor school performance and impairments in social functioning. The FDA approval of this medicine for the treatment of pediatric patients with bipolar depression is significant for several reasons. First, it is a new treatment option for this vulnerable group of young people. Also, it is the first single-agent formulation to receive regulatory approval for this pediatric indication,” said Findling.
Lurasidone is available as a tablet in five strengths: 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg.
The company notes that the effectiveness of lurasidone for longer-term use (>6 weeks) has not been established in controlled studies. It advises physicians who elect to use lurasidone for extended periods to periodically reevaluate the long-term usefulness of the drug for the individual patient. The efficacy of lurasidone in the treatment of mania associated with bipolar disorder has not been established.
Full prescribing information is available online.
For more Medscape Psychiatry news, join us on Facebook and Twitter.
Tidak ada komentar:
Posting Komentar