Evaluating lurasidone as a treatment option for bipolar disorder

ABSTRACT

Introduction: Lurasidone has been approved in the United States as a monotherapy and adjunct for acute bipolar I depression, as well as an antipsychotic for patients with schizophrenia.

Areas covered: Herein, the authors review the pharmacodynamics and pharmacokinetics of lurasidone as well and the major randomized clinical trials. The authors also provide their expert opinion.

Expert opinion: Lurasidone has not been studied in patients with mania or bipolar psychosis. It has been studied, both as a monotherapy and adjunctive treatment to lithium or valproate, in acute depression and in prevention of recurrence of any mood episode in patients with bipolar disorder initially treated for bipolar depression or mania. It is approved in the United States for acute bipolar I depression. It has clinically meaningful treatment effect sizes for improvement in depression compared to placebo (0.51 monotherapy, 0.34 adjunct). The number needed to treat (NNT) for response with monotherapy was 5 (for both lower and higher dose groups), and for remission was 6 and 7 (for lower dose and higher dose groups, respectively); the NNT for adjunctive therapy was 7. It has not demonstrated efficacy in relapse prevention when added to a mood stabilizer but is safe in combination with other medications.

KEYWORDS:

• Lurasidone
• bipolar disorder
• bipolar depression
• serotonin 7 (5HT₇) receptor

Box 1. Drug summary

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Declaration of interest

RS El-Mallakh has received research funding from Janssen Pharmaceuticals and Sage Therapeutics. He has also served on speaker’s bureaus for Allergan, Janssen, Lundbeck, Neurocrine, Otsuka, Takeda and Teva Pharmaceuticals. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Article highlights

• Lurasidone has documented efficacy in the acute treatment of bipolar depression

• Lurasidone has efficacy both as monotherapy and as adjunctive treatment to lithium or valproic acid

• Lurasidone monotherapy is effective in youths and elders with bipolar depression

• Efficacy of lurasidone in the treatment of acute mania has not been investigated

• Lurasidone does not appear to reduce the risk of recurrence into bipolar depression when added to a mood stabilizer in euthymic bipolar subjects

• The safety profile of lurasidone is very advantageous with minimal weight gain, prolactin elevation, or metabolic derangements, even with longer term exposure

Additional information

Funding

This manuscript has not been funded.