Sunovion announced that the FDA has approved an expanded dose range for Latuda (lurasidone) tablets in the treatment of adult patients with schizophrenia. The FDA’s decision followed a review of the supplemental New Drug Application (sNDA) submitted in June 2011.

The maximum recommended dose of Latuda was increased from 80mg/day to 160mg/day based on data from a 6-week placebo and active-controlled trial (n=482) involving two fixed doses of Latuda (80mg/day or 160mg/day) and an active control, Seroquel XR 600mg/day (quetiapine fumarate extended-release; AstraZeneca). Both Latuda doses achieved the primary endpoint by demonstrating statistically significant improvement at the Week 6 study endpoint compared to placebo in change from baseline in Positive and Negative Syndrome Scale total score (PANSS).

The newly expanded recommended dose range of 40–160mg/day includes approval of the 120mg/day and 160mg/day doses, as well as a new 120mg tablet. This dose range reflects positive results from five short-term studies that evaluated the safety and efficacy of Latuda at doses of 40mg/day, 80mg/day, 120mg/day and 160mg/day.

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