Once-daily treatment of schizophrenia

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Product: Latuda

Company: Sunovion

Pharmacologic class: Atypical antipsychotic (benzisothiazol derivative)

Active ingredient: Lurasidone 40 mg, 80 mg; tabs.

Indication: Schizophrenia.

Pharmacology: The mechanism of action of lurasidone, as with other drugs having efficacy in schizophrenia, is unknown. It has been suggested that the efficacy of lurasidone in schizophrenia is mediated through a combination of central dopamine Type 2 and serotonin Type 2 (5-HT2A) receptor antagonism.

Clinical trials: The efficacy of lurasidone was established in four short-term (six-week), placebo-controlled studies in adults who met DSM-IV criteria for schizophrenia. One study included an active-control arm (olanzapine) to assess assay sensitivity. The Positive and Negative Syndrome Scale (PANSS), Brief Psychiatric Rating Scale derived (BPRSd), and Clinical Global Impression severity scale (CGI-S) were used for assessing psychiatric signs and symptoms. The endpoint associated with each instrument was change from baseline in the total score to the end of Week 6.

In a six-week, placebo-controlled trial involving two fixed doses of lurasidone (40 or 120 mg/day), both doses of lurasidone at endpoint were superior to placebo on the BPRSd total score and the CGI-S, as was lurasidone 80 mg/day in another six-week placebo-controlled trial.

In a six-week, placebo- and active-controlled trial involving two fixed doses of lurasidone (40 or 120 mg/day) and an active control (olanzapine), both lurasidone doses and the active control at endpoint were superior to placebo on the PANSS total score and the CGI-S.

In a six-week, placebo-controlled trial involving three fixed doses of lurasidone (40, 80, or 120 mg/day), only the 80-mg/day dose of lurasidone at endpoint was superior to placebo on the PANSS total score and the CGI-S.

Thus, the efficacy of lurasidone at doses of 40, 80, and 120 mg/day was established in two studies for each dose. However, the 120-mg dose did not appear to add additional benefit over the 40-mg dose.

Adults: Take with food (≥350 calories). 40 mg once daily. Maximum 80 mg/day. Moderate-to-severe renal or hepatic impairment, concomitant moderate CYP3A4 inhibitors: maximum 40 mg/day.

Children: Not recommended.

Contraindications: Concomitant strong CYP3A4 inhibitors (e.g., ketoconazole) and inducers (e.g., rifampin).

Warnings/Precautions: Elderly (not for psychosis related to dementia); increased risk of death. Discontinue if neuroleptic malignant syndrome (NMS) occurs; consider discontinuing if tardive dyskinesia occurs. Cardio- or cerebrovascular disease. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor complete blood counts during first few months of therapy; discontinue if WBCs decline. Moderate-to-severe hepatic or renal impairment. Diabetes risk factors (obtain baseline fasting blood sugar). Monitor for hyperglycemia, dyslipidemia, weight gain, hyperprolactin­emia. History of seizures. Exposure to extreme heat. Dysphagia. Write prescription for smallest practical amount. Pregnancy (Cat. B). Nursing mothers.

Interactions: See Adults and Contraindications. Additive central nervous system (CNS) effects with alcohol, other CNS depressants.

Adverse reactions: Somnolence, akathisia, nausea, parkinsonism, agitation; orthostatic hypotension, syncope, hyperglycemia, dyslipidemia, weight gain, hyperprolactinemia, leukopenia/neutropenia, possible NMS, tardive dyskinesia.

How supplied: Tabs — 28 (4 blister cards, 7 tabs), 30, 90, 500

For more information, call 800.739.0565 or visit www.Latuda.com. 

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