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New Latuda data released

May 19, 2011
by News release
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Sunovion Pharmaceuticals, Inc. has released results from a new pooled data analysis related to its Latuda (lurasidone HCl) tablets. Focused on weight and metabolic parameters across short- and long-term studies in adult patients with schizophrenia treated with Latuda, the data were presented at the Annual Meeting of the American Psychiatric Association in Honolulu, Hawaii. Latudareceived U.S. Food and Drug Administration (FDA) approval for the treatment of schizophrenia in October 2010 and was
made available in pharmacies across the U.S. and Puerto Rico in February. The 160 mg/day dose has not been reviewed or approved by the FDA.

The short-term data were pooled from seven double-blind, placebo-controlled, six-week studies in patients with schizophrenia. In this pooled analysis, patients treated with Latuda (once-daily doses of 20-160 mg) experienced, on an overall basis, low rates of weight gain and metabolic changes. The results for the pooled analysis of short-term study data were as follows:

  • Weight*: +0.43 kg for Latuda (n=1486); -0.02 for placebo (n=696)
  • Clinically significant weight gain (≥7%): 4.8% for Latuda (n=1486); 3.3% for placebo (n=696)
  • Total cholesterol**: -5.0 mg/dL for Latuda (n=1419); -5.0 for placebo (n=660)
  • Triglycerides**: -4.0 mg/dL for Latuda (n=1419); -6.0 for placebo (n=660)
  • Glucose**: 0.0 mg/dL for Latuda (n=1453); 0.0 mg/dL for placebo (n=680)

*As measured by mean LOCF endpoint change

** As measured by median LOCF endpoint change

"The potential effect of antipsychotic use on metabolic parameters in patients with schizophrenia is an area of concern for clinicians and the research community," said Antony Loebel, MD, executive vice president, Clinical Research and Medical Affairs at Sunovion Pharmaceuticals. "We are encouraged by the results of this comprehensive database analysis and will continue researching the effect of Latuda on weight and metabolic disturbance in short and longer-term treatment."

Longer-term (ranging from 6-22 months) open-label treatment data were also included in this pooled analysis. The pooled analysis showed that change from baseline at month 12 on weight and various metabolic parameters for Latuda-treated patients versus placebo were as follows:

  • Weight: -0.73 kg (mean) (n=377)
  • Body mass index (BMI): -0.25 kg/m2 (mean) (n=377)
  • Total cholesterol: -2.0 mg/dL (median) (n=307)
  • Triglycerides: -5.0 mg/dL (median) (n=307)
  • Glucose: +1.0 mg/dL (median) (n=307)

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