Sunovion Pharmaceuticals has reported positive results from a study evaluating LATUDA (lurasidone HCI) to treat schizophrenia in adolescents aged 13 to 17 years.
Patients taking fixed doses of LATUDA 40 micrograms per day (mg/d) or 80mg/d in the six-week study indicated statistically significant and clinically meaningful improvement in symptoms of schizophrenia compared to placebo treatment.
LATUDA was well tolerated, with restricted impacts on weight and metabolic parameters.
Johns Hopkins child and adolescent psychiatry director and Kennedy Krieger Institute vice president of psychiatric services and research Robert Findling said: “Early onset schizophrenia can be devastating, and we need treatment options that balance efficacy with a tolerable side effect profile, particularly when it comes to weight gain and metabolic changes.
“These results show that LATUDA may address an unmet need for adolescents and families faced with this complex lifelong illness.”
The data backs the supplemental New Drug Application (sNDA), which has been accepted by the US Food and Drug Administration (FDA).
Acceptance of the sNDA, however, does not indicate that LATUDA will be approved by the FDA for the treatment of adolescents with schizophrenia.
LATUDA is currently indicated in the US for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate, as well as for the treatment of schizophrenia in adults.
In the randomised, double-blind, placebo-controlled six-week study, adolescent patients were randomised to receive fixed doses of LATUDA 40mg/d, LATUDA 80mg/d or placebo.
The primary efficacy endpoint was a change from baseline in the positive and negative syndrome scale (PANSS) total score at Week 6, and the key secondary endpoint was a change from baseline in the clinical global impression-severity (CGI-S) scale at Week 6, which analysed a global severity of illness.
LATUDA was associated with a statistically significant reduction in PANSS total scores and CGI-S scores at Week 6
compared to placebo for both dose groups.
LATUDA was generally well tolerated in both dose groups. The rate of study discontinuation due to adverse events (AEs) was higher in the placebo versus the LATUDA group at 8% and 3.7%, respectively.
Sunovion executive vice president and chief medical officer Antony Loebel said: “We are pleased that the efficacy and tolerability profile of LATUDA for patients with schizophrenia was similar in adolescents compared to that previously seen in adults across multiple studies.
“We believe that LATUDA, if approved, will be an important new therapeutic option for adolescents with schizophrenia.