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Latuda safe, well-tolerated for bipolar depression

Results from an extension study indicated Latuda was safe and well-tolerated with minimal effects on weight or metabolic measures among individuals with bipolar depression.

“The study was conducted to assess the longer-term safety and effectiveness of lurasidone treatment in patients with a recent episode of bipolar depression,” Antony Loebel, MD, executive vice president and chief medical officer at Sunovion, told Healio.com/Psychiatry. “Patients who had completed a short-term, placebo-controlled study that assessed the efficacy and safety of lurasidone used as monotherapy, or adjunctive to lithium or valproate, were eligible for the 6-month, open-label extension study.”

Antony Loebel

Loebel and colleagues assessed safety and tolerability of Latuda (lurasidone hydrochloride, Sunovion Pharmaceuticals, Inc) monotherapy or adjunctive therapy with lithium or valproate over 6 months among 559 individuals with bipolar depression who completed 6 weeks of acute treatment. Participants received flexible doses of lurasidone, ranging from 20 mg to 120 mg per day, for 6 months.

Discontinuation due to an adverse event occurred in 6.9% of participants who received lurasidone monotherapy and 9% of those who received adjunctive therapy.

Mean changes in weight from double-blind baseline to month 6 were 0.8 kg in the monotherapy group and 0.9 kg in the adjunctive therapy group.

Median changes in total cholesterol were 0 mg/dL in the monotherapy group and 2 mg/dL in the adjunctive therapy group.

Median change in triglycerides was the same for participants who received monotherapy or adjunctive therapy, at 5 mg/dL.

Median changes in glucose were –1 mg/dL in the monotherapy group and 0 mg/dL in the adjunctive therapy group.

Mean changes in Montgomery-Asberg Depression Rating Scale scores were –22.6 in the monotherapy group and –21.7 in the adjunctive therapy group.

From open-label baseline to month 6, mean changes in weight gain were 0.85 kg in the monotherapy group and 0.88 kg in the adjunctive therapy group. Mean changes in Montgomery-Asberg Depression Rating Scale scores were –6.9 in the monotherapy group and –6.5 in the adjunctive therapy group.

“Lurasidone is FDA-approved for use as monotherapy or adjunctive therapy in patients with bipolar depression, based on the results of two positive, short-term, placebo-controlled trials. The findings reported here suggest that for patients with bipolar depression, lurasidone may be an effective and well-tolerated treatment option, whether used as monotherapy or adjunctive to lithium or valproate, over a 6-month treatment period,” Loebel said. – by Amanda Oldt

Disclosure: The study was sponsored and funded by Sunovion. Please see the full study for a list of all authors’ relevant financial disclosures.