Sunovion's Latuda non-inferior to AstraZeneca's Seroquel XR in risk relapse for schizophrenia patients

Sunovion Pharmaceuticals (SEPR: US) has announced results from a 12-month, double-blind extension study comparing drug Latuda (lurasidone HCl) to AstraZeneca’s Seroquel XR (quetiapine) in adult patients with schizophrenia. The results of the extension study demonstrated Latuda, which was approved for schizophrenia treatment by the US Food and Drug Administration in October 2010, to be non-inferior to Seroquel XR in risk for relapse.

The primary efficacy endpoint was time to relapse of psychotic symptoms, applying pre-specified relapse criteria. The primary analysis utilized a Cox proportional hazards model to assess non-inferiority of Latuda compared to Seroquel XR. Results of this analysis showed a hazard ratio of 0.728 (indicating a 27% lower risk of relapse for Latuda), with an upper limit of the 95% CI of 1.295. Since the protocol pre-specified margin for non-inferiority was 1.93, this study successfully demonstrated non-inferiority of Latuda versus Seroquel XR.

Adverse events (greater than or equal to 5%) associated with Latuda included akathisia, headache, insomnia, anxiety, increased weight and parkinsonism. Adverse events associated with Seroquel XR (greater than or equal to 5%) included schizophrenia, headache, insomnia, psychotic disorder, increased weight and agitation. Latuda was also associated with low rates of weight gain and metabolic changes.