INVEGA® (paliperidone) extended-release tablets are an oral atypical antipsychotic indicated for the treatment of schizophrenia and for the treatment of schizoaffective disorder.

What is schizoaffective disorder?

  • Schizoaffective disorder is a chronic mental illness with overlapping periods of psychoses and major affective episodes3

About schizoaffective disorder

  • Up to 1 in 3 patients presenting with symptoms suggestive of acute or chronic psychosis* may actually have schizoaffective disorder3-5
  • The temporal aspects of schizoaffective disorder present unique challenges in diagnosing patients
  • Challenges with the acute treatment of schizoaffective disorder include:
    • Shares clinical symptoms with other psychiatric disorders
    • Lack of clinical trial data
    • No previously approved medication

INVEGA® is the only Oral atypical antipsychotic approved for
the treatment of schizoaffective disorder

INVEGA® in the treatment of schizoaffective disorder

INVEGA® Efficacy

  • INVEGA® (3 mg, 6 mg, 9 mg, 12 mg) demonstrated significant improvements in Positive and Negative Syndrome Scale (PANSS) total scores vs placebo as monotherapy (P<0.001) and as adjunctive therapy (P=0.014)†‡9
    • In pivotal trials, numerical improvement in Young Mania Rating Score (YMRS) total score was larger with INVEGA® compared to placebo, regardless of administration as monotherapy or adjunctive therapy9
      • INVEGA® is not indicated for treatment of manic episodes in bipolar I disorder
    • In pivotal trials, numerical improvement in Hamilton Depression Rating Scale (HAM-D-21) total score was larger with INVEGA® compared to placebo, regardless of administration as monotherapy or adjunctive therapy9
      • INVEGA® is not indicated for treatment of depressive episodes in Major Depressive Disorder

INVEGA® Efficacy

INVEGA® Dosing & Administration

  • The recommended starting dose of INVEGA® is 6 mg once daily
  • Morning administration is recommended due to the extended-release formulation
  • Initial dose titration is not required
  • Dosing of 3 mg to 12 mg provides greater flexibility for patients who may benefit from higher or lower doses§
  • Dose adjustment should occur only after clinical reassessment and should occur at intervals of more than 4 days

INVEGA® Dosing & Administration

INVEGA® Safety

In pooled data from two 6-week clinical trials:

  • A higher percentage of subjects treated with INVEGA® (5%) had an increase in body weight of ≥7% compared with subjects treated with placebo (1%)
  • In the study that examined high- and low-dose groups, the increase in body weight of ≥7% was 3% in the low-dose group, 7% in the high-dose group, and 1% in the placebo group
  • A dose-related increase in EPS was not observed for parkinsonism or akathisia
  • There was a dose-related increase observed with spontaneous EPS reports of hyperkinesia and dystonia and in the use of anticholinergic medications
  • Discontinuation rates due to adverse reactions for INVEGA® and placebo were 1% and <1% respectively
  • See below for additional Important Safety Information

INVEGA® Safety

*Among patients aged 18-65. Excludes psychosis due to substance abuse or any other medical disorder.
Approved in the treatment of schizoaffective disorder as monotherapy or as an adjunct to mood stabilizers and/or antidepressants. In the 2 pivotal clinical studies, the most commonly used mood stabilizers were valproate and lithium. The most commonly used antidepressants were SSRIs and SNRIs. MAOIs were excluded.
Combined data from the flexible-dose study and the 2-dose-level study for the treatment of schizoaffective disorder.
§The efficacy of the 1.5-mg dose has not been established in clinical trials.