FDA approves Sunovion drug for schizophrenic teenagers
Sunovion is headquartered in Marlborough.
Sunovion Pharmaceuticals has received approval from the U.S. Food and Drug Administration for its novel drug Latuda, for the treatment of schizophrenia in kids ages 13 to 17.
The approval, announced over the weekend, marks the first FDA-approved treatment for adolescents with schizophrenia in five years. The Marlborough company gained its approval based on a randomized, double-blind, placebo-controlled, six-week study where adolescent patients with schizophrenia received fixed doses of either 40 milligrams of Latuda, 80 milligrams of Latuda, or placebo per day.
By the end of the study, children who received either 40 milligrams or 80 milligrams per day were associated with statistical and clinical improvement in symptoms of schizophrenia, compared to the placebo. The drug was also found to be well-tolerated, with limited effects on weight and metabolic parameters.
Latuda is also approved in the U.S. for the treatment of adults with schizophrenia and for adults with major depressive episodes associated with bipolar depression, either as a single treatment or a complementary treatment with other mental health drugs, like lithium or valproate.
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