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85% of Patients with Schizoaffective Disorder on INVEGA SUSTENNA® Remained Relapse-Free After 15 Months1
Overall efficacy1,2
INVEGA SUSTENNA® helped more patients remain relapse-free vs placebo, both as1:
Monotherapy: 88% vs 67%
Adjunctive therapy*: 81% vs 66%
*Adjunct to antidepressants or mood stablizers.
Patients Treated With INVEGA SUSTENNA® Who Did Not Relapse Due to Psychotic or Mood Symptoms Over 15 Months1
Symptoms of schizoaffective disorder1
Of the patients who relapsed on INVEGA SUSTENNA® (n=25) and placebo (n=57), the majority of patients experienced symptoms of both psychosis and mood at the time of their relapse. Eight of the 82 patients experienced a relapse without psychotic symptoms, and 16 of the 82 patients experienced a relapse without mood symptoms.1
Indicated for the treatment of schizoaffective disorder.
The full constellation of symptoms and the relevant diagnostic criteria should be consulted and are available in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5 ®, or current version), where applicable.
A 15-Month Study Evaluated the Efficacy and Safety of INVEGA SUSTENNA® vs Placebo for Schizoaffective Disorder1,2
Abbreviated study design1,2
In patients experiencing an acute exacerbation of psychotic and manic/depressive mood symptoms
Double-blind baseline patient demographics (n=334)2:
- Attempted suicide: 18% (n=60)
- History of substance abuse: 27% (n=90)
- Inpatient at study entry: 31% (n=105)
- Concomitant antidepressants: 23% (n=78)
- Concomitant mood stabilizers: 31% (n=105)
Study Design
The primary endpoint was time to relapse. Adult patients with schizoaffective disorder were treated for 13 weeks during an open-label, flexible-dose lead-in phase with INVEGA SUSTENNA® as monotherapy and as an adjunct to mood stabilizers or antidepressants (78-mg, 117-mg, 156-mg, or 234-mg), followed by a 12-week, open-label, fixed-dose stabilization period. Patients who maintained stabilization criteria were then randomized to this same dose or to placebo in the 15-month, double-blind, maintenance phase.1,2
Indicated for the treatment of schizoaffective disorder.
The full constellation of symptoms and the relevant diagnostic criteria should be consulted and are available in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5 ®, or current version), where applicable.
Relapse Criteria1
In this study, relapse was defined as the first occurrence of ≥1 of the following1:
- Psychiatric hospitalization
- Intervention employed to avert hospitalization
- Clinically significant self-injury, suicidal or homicidal ideation, or violent behavior
- Worsening of schizoaffective symptoms (defined by PANSS item scores, total scores, or CGI-S-SCA scores)†‡
PANSS=Positive and Negative Syndrome Scale; CGI-S-SCA=Clinical Global Impression for Severity of Schizoaffective Disorder.
†Defined as a score of ≥6 (if the score was ≤4 at randomization) of any of the individual PANSS items: delusions, conceptual disorganization, hallucinatory behavior, excitement, suspiciousness/persecution, hostility, uncooperativeness, or poor impulse control.
‡Defined as 2 consecutive assessments within 7 days showing ≥25% increase (if the score at randomization was >45) or ≥10-point increase (if the score at randomization was ≤45) in total PANSS score; a score of ≥5 (if the score was ≤3 at randomization) of any of the individual PANSS items: delusions, conceptual disorganization, hallucinatory behavior, excitement, suspiciousness/persecution, hostility, uncooperativeness, or poor impulse control; an increase of ≥2 points (if the score was 1 [not ill] to 3 [mildly ill] at randomization) or increase of ≥1 point (if the score was ≥4 [moderately ill or worse] at randomization) in CGI-S-SCA overall score.
INVEGA SUSTENNA® Provides Rapid§ and Sustained Plasma Levels for up to 1 Month1,3
No oral supplementation during initiation, including day 11
Due to the difference in median pharmacokinetic profiles between the 2 products, INVEGA SUSTENNA® and INVEGA® (paliperidone) oral, caution should be exercised when making a direct comparison of their pharmacokinetic properties.1
§After both initiation doses.
ll INVEGA SUSTENNA® initiation regimen allowed patients to stay in this exposure window of 6 mg to 12 mg extended-release oral paliperidone.
¶Initiation doses must be administered in the deltoid muscle.
#First maintenance dose should be administered on day 36 and once monthly thereafter.
Figure adapted with permission from Samtani MH et al. CNS Drugs. 2011;25(10):829-845.
Figure adapted with permission from Samtani MH et al. CNS Drugs. 2011;25(10):829-845.
References: 1. INVEGA SUSTENNA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; January 2019. 2. Fu D-J, Turkoz I, Simonson RB, et al. Paliperidone palmitate once-monthly reduces risk of relapse of psychotic, depressive, and manic symptoms and maintains functioning in a double-blind, randomized study of schizoaffective disorder. J Clin Psychiatry. 2015;76(3):253-262. 3. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ.