Reagila® (cariprazine) delivers simultaneous efficacy on both the positive and negative symptoms of schizophrenia and prevents relapse in the long term. Reagila was tested in two different patient populations with schizophrenia:
Schizophrenia with exacerbation of symptoms: REAGILA® is an effective, broad-spectrum treatment for schizophrenia symptoms and relapse prevention.
Cariprazine was tested in three pivotal, multinational, randomized, double-blind, placebo-controlled trials in non-elderly adults (age 18-60, mean duration of disease 11.4 years, total N=1792) hospitalized for an acute exacerbation of schizophrenia. Six weeks of treatment with cariprazine demonstrated statistically superior improvements in the primary (PANSS total score) and secondary (CGI-S) efficacy outcomes vs. placebo over its entire dose range studied. The onset of significant superiority vs. the placebo response in PANSS total scores was generally observed as early as week 2 for the lower cariprazine doses (1.5-3.0 mg/day) and already at week 1 for the higher doses (4.5 mg/day and above). To support the long-term efficacy of cariprazine, a multinational randomized-withdrawal relapse prevention study was conducted in patients (N=200) whose disease remained stable during a 20-week open-label cariprazine therapy. After randomization to a double-blind treatment of up to 72-week duration, cariprazine 3-9 mg/day cut the risk of relapse by more than half vs. placebo. In the approved dose range of 3-6 mg/day, the risk of relapse was reduced by 60% (N=102, 95%CI: 18-80%).
Schizophrenia with predominant negative symptoms: REAGILA® is the only antipsychotic with a proven superiority over another second-generation antipsychotic.
Negative symptoms are a key feature of schizophrenia that pose a strong limitation on the real-life functioning of patients. In order to establish whether antipsychotic drugs are truly effective on primary negative symptoms (as opposed to negative symptoms secondary to positive, extrapyramidal, or depressive symptoms), studies in specific populations are required. A multinational, randomized, double-blind, active-controlled trial was conducted with a 26-week treatment duration in 460 adults (18-65) with schizophrenia eliciting predominant negative symptoms.4 Cariprazine (4.5 mg/day) was shown to be superior to risperidone (4.0 mg/day) in reducing the negative symptoms (PANSS FSNS, P=0.0022) and improving patients' functionality and personal relationships (PSP total score, P<0.0001). Cariprazine’s effect size on negative symptoms vs. risperidone (0.31) was comparable to the effect size of other antipsychotics vs. placebo (0.42) in this patient population, thus almost doubling the total effect size vs. placebo (although this is an indirect comparison). These improvements purely occurred due to the improvement of negative symptoms independently of those in positive, depressive, or extrapyramidal symptoms.
In open-label extension studies for up to 48 weeks of cariprazine therapy (N=679)7,8, the results from 350 patient-years of exposure support the good safety and tolerability profile of cariprazine within the dose range of 1.5–6 mg/day approved by both the FDA and EMA for the treatment of schizophrenia.
The D2/D3 receptor partial agonist cariprazine’s broad-spectrum efficacy, good tolerability, and advantage on primary negative symptoms vs. risperidone is attributed to its in vitro as well as in vivo preference for D3 receptors, a unique feature among antipsychotics, and the considerable affinity to 5-HT1A receptors.
Source: https://reagila.pro/