Sunovion announced the publication of data from a randomized, double-blind, placebo-controlled study that evaluated the efficacy of low-dose Latuda(lurasidone HCl) 20mg daily in adults with schizophrenia, and the effect of dose escalation in adults who demonstrated inadequate initial response to standard dose Latuda. The full findings have been published in the Journal of Clinical Psychiatry

The study assigned hospitalized patients with acute schizophrenia to Latuda 20mg daily, Latuda 80mg daily, or placebo. Non-responders to Latuda 80mg daily, specifically those with PANSS score decrease <20% at 2 weeks, were re-randomized to Latuda 80mg daily or Latuda 160mg daily for the remaining 4 weeks of the study. The primary outcome was change from baseline to Week 6 in PANSS total score. 

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The study found that Latuda 20mg daily was not associated with significant improvement in psychotic symptoms in adults with schizophrenia, indicating that the lowest effective dose of Latuda is 40mg daily, as found in the prescribing information. The least squares (LS) mean change from baseline to Week 6 in PANSS total score for low-dose Latuda vs. placebo was –17.6 vs. –14.5; P=0.26, respectively.

Also, the study found that for adult patients with schizophrenia who did not respond to 2 weeks of treatment with Latuda 80mg daily, increasing to 160mg daily led to significant symptom improvement over the next 4 weeks vs. those who remained on 80mg daily. The LS mean change from Week 2 to Week 6 in PANSS total score for Latuda 160mg daily vs. Latuda 80mg daily was –16.6 vs. –8.9; P<0.05, respectively. Researchers also reported that Latuda was generally well-tolerated. 

Study author Leslie Citrome, MD, MPH, stated, “The results of this study have significant implications for clinical practice as they provide evidence that dose escalation with Latuda in non-responders can improve patient outcomes.” 

Latuda, an atypical antipsychotic, is also indicated for major depressive episodes associated with bipolar I disorder as monotherapy and as adjunctive therapy with lithium or valproate. It is available as 20mg, 40mg, 60mg, 80mg, and 120mg strength tablets.

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