The PEARL 3 study was part of an extensive worldwide clinical development program involving more than 2,900 subjects, which evaluated the safety and efficacy of Latuda.
In this six-week, placebo-controlled trial, both fixed doses of Latuda 80 and 160 mg once-daily, demonstrated statistically significant improvement in symptoms of schizophrenia versus placebo across both primary and secondary efficacy measures.
Latuda was also well tolerated with a relatively low discontinuation rate.
The Latuda 160 mg/day dose has not been reviewed or approved by FDA.
Sunovion, dedicated to discovering, developing and commercialising therapeutic products that advance the science of medicine in the central nervous system (CNS) and respiratory disease areas, is an indirect, wholly-owned subsidiary of Dainippon Sumitomo Pharma.