FDA Clears Lurasidone for Schizophrenia in Adolescents

FDA Clears Lurasidone (Latuda) for Schizophrenia in Adolescents
Megan Brooks | Disclosures
January 30, 2017

The US Food and Drug Administration (FDA) has approved a supplemental new drug application for lurasidone (Latuda, Sunovion Pharmaceuticals Inc) for the treatment of schizophrenia in adolescents aged 13 to 17 years, the company has announced.

Lurasidone, a serotonin dopamine antagonist, is the first treatment to be approved in 5 years for adolescent patients with schizophrenia, the company noted in a news release.

Lurasidone is already approved in the United States for the treatment of adults with schizophrenia as well as adults with bipolar depression as monotherapy and as adjunctive therapy with lithium or valproate.

The FDA approval of lurasidone for adolescents with schizophrenia was based on a randomized, double-blind, placebo-controlled, 6-week study in which adolescents with schizophrenia received lurasidone 40 or 80 mg/day or placebo.

Both doses of lurasidone were associated with statistical and clinical improvement in symptoms of schizophrenia compared to placebo. Lurasidone was generally well tolerated, with limited effects on weight and metabolic parameters, the company said.

Past research has shown that psychosis that develops during adolescence may be more severe and is associated with a poorer prognosis than adult-onset schizophrenia. Delays in treatment after onset of psychotic symptoms may be two to three times longer for adolescents than adults and are associated with poorer treatment outcomes and response to treatment.

“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,” Robert Findling, MD, vice president, psychiatric services and research, Kennedy Krieger Institute, and director of child and adolescent psychiatry, Johns Hopkins University School of Medicine, Baltimore, Maryland, and a study investigator, said in the release.

“The availability of Latuda provides healthcare providers with an important new option for helping adolescents with this illness that is chronic and severely disabling,” added Dr Findling.


now kids can have flat affects and limp dicks too

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yea sure it does. All it does is keep you out of the hospital but you will have breakthrough symptoms too. Its like rat poison

I definitely don’t agree with adolescents being prescribed stuff like that.

Latuda was absolutely terrible to me, what did everyone else think was bad about it?

Im on it now, Its slightly better than geode but it still sucks so badly to take.
Im on 40mg and I’m not sure how much longer I can last.

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i loved latuda as compared to risperdal. i went straight from risperdal to latuda and my research made me think i had the best drug. drugs do effect people way differently im on abilify now

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the problem is the stiffness, the sexual side effects and the flat affect that it does to my emotions or the lack of ability to feel pleasure. I need an antipsychotic but god damn can’t they make one with less side effects?

I’m not willing to try Latuda.
My psychiatrist said that it causes a lot of Anxiety.
Thanks but no thanks

Latuda wasn’t a positive experience for me either but it did what I wanted it to, kept my neurotransmission variable rather than stagnating on one drug. Whenever possible trial antipsychotics with very different chemical structures and effects to what you are used to. You need to keep your brain adapting so you can adjust to the peaks and troughs of schizophrenia.

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