Schizophrenia Drug Approved
The US Food and Drug Administration has approved a supplemental New Drug Application for Latuda (lurasidone HCI; Sunovion) for the treatment of schizophrenia in adolescents aged 13 to 17 years. The drug is already approved for use in adults with schizophrenia or adult with major depressive episodes associated with bipolar I disorder as monotherapy and as adjunctive therapy with lithium or valproate.
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Schizophrenia is a chronic, serious, and often severely disabling brain disorder. The condition is associated with hallucinations and delusion that typically start occurring between the ages of 16 and 30 years. Patients may also experience unusual or dysfunctional ways of thinking, agitated body movements, reduced expression of emotions and cognitive symptoms such as poor focus, memory or executive functioning.
The severity of the condition as well as its potential impact on adolescent development highlights the need for early diagnosis and effective treatment. This is especially true for adolescents, who are more likely to experience social and developmental impairments and are associated with poorer treatment outcomes compared with adults.
The decision to approve lurasidone HCI comes after results from a randomized, double-blind, placebo-controlled, six-week study in which adolescent patients with schizophrenia who were treated with the drug achieved statistical and clinical improvement in symptoms of schizophrenia compared with placebo.
“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, the company that filed the New Drug Application. “This approval builds on and reflects our commitment to advancing the treatment of serious psychiatric illness.”
Lurasidone HCI is also associated with some serious side effects, including stoke and neuroleptic malignant syndrome, a rare, but serious condition that can cause death and must be treated at a hospital. Increases in blood sugar, riglycerides, and cholesterol may also occur.—Sean McGuire
Reference
Sunovion’s Latuda® (lurasidone HCl) Receives FDA Approval to Treat Adolescents with Schizophrenia [press release]. Marlborough, MA: Business Wire; January 28, 2017. https://www.businesswire.com/news/home/20170128005011/en/Sunovion%E2%80%99s-Latuda%C2%AE-lurasidone-HCl-Receives-FDA-Approval. Accessed January 30, 2017.
