Sunovion Pharmaceuticals has published results in the journal Depression and Anxiety from a six-month, open-label extension study that evaluated the long-term safety, tolerability and effectiveness of Latuda (lurasidone HCI) when used either as monotherapy or as adjunctive therapy in combination with lithium or valproate in adults with major depressive episodes associated with bipolar I disorder (bipolar depression).

The study found that six months of once-daily treatment with flexibly-dosed Latuda (20–120 mg), following a six-week, placebo-controlled treatment period, was well-tolerated with minimal change in weight and metabolic parameters.

Secondary analyses also showed that six months of open-label Latuda treatment was associated with sustained improvement in depressive symptoms based on observed case data over time and assessed using the Montgomery-Asberg Depression Rating Scale (MADRS).

Latuda is an atypical antipsychotic agent indicated in the United States for the treatment of adult patients with bipolar depression, both as monotherapy and as adjunctive therapy with lithium or valproate, and for the treatment of adult patients with schizophrenia.

“Bipolar disorder is a chronic illness and the depressive phase, also referred to as bipolar depression, can be particularly debilitating,” said Antony Loebel, M.D., executive vice president and chief medical officer, Sunovion. “The safety and efficacy of Latuda in treating bipolar depression has been well established in short-term trials, and results from this open-label extension study provide additional evidence to support its safety, tolerability and effectiveness over the long-term.”

This six-month, open-label extension of three six-week, placebo-controlled studies was designed to evaluate the long-term safety and tolerability of Latuda in patients with bipolar depression. A secondary aim was to evaluate the effectiveness of Latuda in maintaining improvement in depressive symptoms.

The study enrolled patients who had recently completed one of three six-week, double-blind trials evaluating the safety and efficacy of Latuda compared to placebo for the treatment of bipolar depression, either as monotherapy or as adjunctive therapy with lithium or valproate. Eight hundred thirteen patients were treated for up to six months (monotherapy, 38.9%; adjunctive therapy, 61.1%) with flexible doses of Latuda, ranging from 20–120 mg/day. Five hundred fifty-nine patients completed the extension study, with 6.9% and 9.0% in the monotherapy and adjunctive therapy groups, respectively, discontinuing due to an adverse event. The results for the monotherapy and adjunctive therapy groups, respectively, for changes from double-blind baseline to month six were as follows based on last observation carried forward (LOCF analysis):

• Mean changes in weight: +0.85 and +0.88 kg
• Median changes in total cholesterol: 0.0 and +2.0 mg/dL
• Median changes in triglycerides: +5.0 and +5.0 mg/dL
• Median changes in glucose: -1.0 and 0.0 mg/dL

“While the major focus of most clinical trials is on the treatment of acute episodes in bipolar disorder, the main concern for patients in our clinics is on sustained improvement and their fear of recurrences,” said John Beyer, M.D., professor of Psychiatry and Behavioral Sciences at Duke University School of Medicine and director of Duke Mood and Anxiety Disorder Clinic. “This extension study provides evidence that Latuda may have a role in the clinician’s armamentarium for sustained treatment.”