Latuda is the first drug approved in 5 years for the treatment of adolescent schizophrenia.
Sunovion Pharmaceuticals announced that the FDA approved the supplemental new drug application for Latuda (lurasidone HCI) to treat schizophrenia in patients aged 13 to 17.
Latuda is also approved to treat adults with schizophrenia or with major depressive episodes related to bipolar depression, according to a press release. The drug can be used as a monotherapy, or with lithium or valproate in these patients.
“The impact on development and poor prognosis frequently associated with schizophrenia that begins in adolescence underscores the need for treatment that is both well-tolerated and effective,” said researcher Robert Findling, MD, MBA. “The availability of Latuda provides healthcare providers with an important new option for helping adolescents with this illness that is chronic and severely disabling.”
The new approval is based on positive findings from a randomized, 6-week clinical trial of Latuda in patients with schizophrenia. In the study, patients were treated with 40-mg/day or 80-mg/day of Latuda, or placebo.
At the conclusion of the trial, the researchers found that treatment with Latuda was linked to statistical and clinical improvements in symptoms of schizophrenia, compared with placebo. The drug was found to be well-tolerated in patients, and had limited effects on weight and metabolic measurements, according to the study.
This approval marks the first new treatment in 5 years indicated for adolescent patients with schizophrenia, where treatment options are limited.
The severity, impact on physical and cognitive development, and poor prognosis of schizophrenia in adolescents, underscores the need for early detection, swift diagnosis, and effective treatment, according to the press release.
Compared with adult-onset schizophrenia, adolescents experience a more severe onset of psychotic symptoms, and are more likely to experience social and developmental impairments, Sunovion reported. Patients with schizophrenia experience hallucinations, delusions, unusual thinking, agitated body movements, reduced expressions of emotions, and poor cognitive function.
Delays to treatment for adolescents with schizophrenia may be 2 to 3 times longer, compared with adults. These delays may result in poor outcomes and diminished response to treatments, which shows the importance of early detection.
Sunovion believes that Latuda’s new indication will greatly benefit younger patients with schizophrenia, whose severe symptoms require prompt and effective treatment.
“We are pleased that Latuda’s range of indications has now expanded beyond the adult population to include the treatment of schizophrenia in adolescents aged 13 to 17 years. We believe that Latuda, as the first such medication in five years approved for adolescent patients with schizophrenia, is an important new treatment option for this difficult to treat illness,” said Antony Loebel, MD, executive vice president and Chief Medical Officer at Sunovion. “This approval builds on and reflects our commitment to advancing the treatment of serious psychiatric illness.”