The US Food and Drug Administration (FDA) has approved lurasidone (Latuda, Sunovion Pharmaceuticals), already indicated for schizophrenia, to treat major depressive episodes in adults with bipolar 1 disorder, the manufacturer announced last Friday.
Clinicians can prescribe lurasidone by itself or together with either lithium or valproate for this new indication.
Sunovion Pharmaceuticals stated in a news release that the FDA decision was supported by 2 clinical trials, one for lurasidone as an adjunctive therapy (PREVAIL1), and the other for the drug as a monotherapy (PREVAIL2).
In both trials, patients taking lurasidone experienced a reduction in depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale after 6 weeks compared with the group on a placebo. Patients taking lurasidone scored statistically significant improvements on other measures of mental health that consider such things as remission rates, anxiety symptoms, and enjoyment and quality of life, according to the manufacturer.
Akathisia, extrapyramidal symptoms, somnolence, nausea, vomiting, diarrhea, and anxiety were the most common adverse events for patients taking lurasidone as a monotherapy. In the study of lurasidone as an adjunctive therapy, the most common adverse reactions were akathisia and somnolence. Discontinuation rates stemming from adverse events were 6% for patients taking lurasidone by itself and 5.8% for those taking it along with lithium or valproate. Among patients in both studies who received a placebo, the discontinuation rate was about 5%.
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