The FDA has approved the stretched dose range for Sunovion Pharmaceuticals’ Latuda for the treatment of patients with schizophrenia.
After the review of the supplemental new drug application (sNDA), which was submitted in June 2011, the FDA has announced the decision.
Sunovion executive vice president and chief medical officer Antony Loebel said, “Schizophrenia is a complex disorder that requires a careful assessment of each patient. Having added dosing flexibility for LATUDA will allow physicians to better tailor treatment to the individual needs of patients with schizophrenia.”
The newly extended recommended dose range for Latuda (40-160mg/day) consists of approval of the 120mg/day and 160mg/day doses, as well as a new 120mg tablet, the company said.
The expanded dose range reflects positive results from five short-term studies that evaluated the safety and efficacy of Latuda where doses were shown to be safe and effective.