Janssen-Cilag International NV has announced that the European Commission has approved an extension of the oral atypical antipsychotic INVEGA® (paliperidone ER) schizophrenia indication, to include adolescents aged 15 years and older. The decision from the European Commission follows a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in April 2014.
"This decision means that INVEGA® becomes an additional treatment choice available to physicians and to young people living with schizophrenia," said Andreas Schreiner, European Therapy Area Lead, Neuroscience and Pain. "We are therefore delighted that the European Commission has approved INVEGA® for the treatment of schizophrenia in adolescents aged 15 years and over."
The approval is based on results from three pivotal Phase 3 studies with INVEGA® in adolescents. Results showed that INVEGA® has a safety and efficacy profile in adolescents similar to that observed in adults with schizophrenia. In the first, a six-week, randomised, double-blind, placebo controlled study, INVEGA® 3 mg, 6 mg and 12 mg once daily dose strengths resulted in improvements in symptoms of schizophrenia in adolescents.
As an extension to this study, a large two-year open label multicentre Phase 3 study, demonstrated the tolerability and efficacy of flexibly dosed INVEGA®. The data also support the efficacy of INVEGA® in maintaining symptom stability for schizophrenia over the two year treatment period in this patient population.
The third Phase 3 study was a double-blind randomised controlled study which evaluated the efficacy, safety and tolerability of INVEGA® relative to oral aripiprazole, another antipsychotic licensed for the treatment of adolescent schizophrenia. The results showed a robust and clinically relevant improvement with INVEGA® in symptom and functional measurements, and demonstrated a tolerability profile similar to that observed in an adult population.
While schizophrenia is a lifelong condition, effective treatments can help people with schizophrenia to live a normal life. Clinical guidelines recommend a combination of medication and psychotherapy, psycho-education and self-help. Beyond simply controlling symptoms, effective treatment means that people living with the condition have a much better chance of returning to, or continuing their work or study and managing independent living and social relationships, which in turn can aid their recovery.
About the Phase 3 studies
Patients were randomised to receive either placebo or one of three weight-based, fixed doses of paliperidone ER, once-daily (patients weighting 29 - <51 kg at baseline: 1.5 mg [low], 3 mg [medium] or 6 mg [high]; patients weighing ≥51 kg: 1.5 mg [low], 6 mg [medium], 12 mg [high]). The results showed that paliperidone ER was tolerable, and no new safety concerns were observed.
Predictors of response were: paliperidone ER treatment group (medium and high dose combined), shorter duration of illness (≤2 years), and greater illness severity.
Paliperidone ER demonstrated general tolerability for the treatment of schizophrenia in adolescents. Growth and maturation were similar to normal adolescent maturation. Results also showed that efficacy was also maintained over the 2-year treatment period.
A double blind, flexible-dose study (8-week acute, 18-week maintenance) in adolescents (N=226) randomised to paliperidone ER or oral aripiprazole demonstrated that paliperidone ER and aripiprazole had similar treatment effects, as there were no significant differences in primary or secondary efficacy measurements between the two treatment groups. Both drugs showed robust and clinically relevant improvements in symptom and functional measurements, and were generally well tolerated with a safety profile similar to that observed in adults with schizophrenia.