Sunovion Pharmaceuticals Inc. recently announced study results that indicated Latuda statistically significantly improved schizophrenia symptoms among adolescents.
“These results show that Latuda may address an unmet need for adolescents and families faced with this lifelong complex illness,” study researcher Robert Findling, MD, MBA, of Kennedy Krieger Institute and Johns Hopkins, said in a press release.
To assess efficacy and safety of Latuda (lurasidone, Sunovion Pharmaceuticals) for schizophrenia in adolescents, researchers conducted a randomized, double-blind, placebo-controlled 6-week study in which adolescents were randomly assigned to receive fixed doses of lurasidone at 40 mg or 80 mg per day.
At week 6, Positive and Negative Syndrome Scale (PANSS) total scores improved by –8 (P < .001) and Clinical Global Impression-Severity (CGI-S) scores improved by –0.47 (P < .001) among individuals who received 40 mg of lurasidone.
Among those who received 80 mg of lurasidone, PANSS scores improved by –7.7 (P < .001) and CGI-S scores improved by –0.42 (P = .002).
Additional data indicated lurasidone was associated with minimal changes in weight and metabolic parameters.
Lurasidone was well-tolerated in both dosage groups, according to the release.
Study discontinuation due to adverse events was higher among the placebo group vs. the lurasidone group (8% vs. 3.7%).
The most common adverse events for lurasidone, which had an incidence of 5% or higher, included somnolence, nausea, akathisia and vomiting.
These findings support a supplemental New Drug Application accepted by the FDA.
“We are pleased that the efficacy and tolerability profile of Latuda for patients with schizophrenia was similar in adolescents to that previously seen in adults across multiple studies,” Antony Loebel, MD, executive vice president and chief medical officer of Sunovion, said in the release. “We believe that Latuda, if approved, will be an important new therapeutic option for adolescents with schizophrenia.”