Latuda Dosing Range Updated
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.
For more information call (800) 739-0565 or visit www.latuda.com.