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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

INVEGA SUSTENNA® (paliperidone palmitate)

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Clinical Overview of INVEGA SUSTENNA

Last Updated: 10/10/2024

Summary

INVEGA SUSTENNA (paliperidone palmitate 1-month [PP1M]) is indicated for the treatment of schizophrenia in adults.¹ INVEGA SUSTENNA is also indicated for the treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants.²
Dosage and Administration: After establishing tolerability, initiate INVEGA SUSTENNA with a dose of 234 mg on treatment day 1 and 156 mg one week later, both administered in the deltoid muscle. Following the second dose, monthly maintenance doses can be administered in either the deltoid or gluteal muscle.¹^,³^,⁴ Please refer to the Prescribing Information for dosage in specific populations.
- Schizophrenia: The recommended monthly maintenance dose is 117 mg. Some patients may benefit from lower or higher maintenance doses within the additional available strengths (39 mg, 78 mg, 156 mg, and 234 mg).¹^,⁴
- Schizoaffective Disorder: The recommended monthly maintenance dose range is 78 to 234 mg.³^,⁵
Adverse Reactions: The most common (at least 5% in any INVEGA SUSTENNA group) and likely drug-related (adverse events for which the drug rate is at least twice the placebo rate) adverse reactions from the double-blind, placebo-controlled trials in subjects with schizophrenia were injection site reactions, somnolence/sedation, dizziness, akathisia, and extrapyramidal disorder.⁴ No occurrences of adverse events reached this threshold in the long-term double-blind, placebo-controlled study in subjects with schizoaffective disorder. In the schizoaffective disorder clinical trial, adverse reactions that occurred more frequently in the INVEGA SUSTENNA than the placebo group (a 2% difference or more between groups) were weight increased, nasopharyngitis, headache, hyperprolactinemia, and pyrexia.⁵

DOSAGE STRENGTH INFORMATION

Doses of paliperidone palmitate extended-release injectable suspension may be expressed in milligram equivalents of paliperidone (active moiety) or milligrams of paliperidone palmitate. Dosage information in this response has been converted to mg of paliperidone palmitate to reflect the commercially available dosage strengths in the United States. The conversion factor from mg eq. to mg is 1.56.

INVEGA SUSTENNA doses expressed as 39, 78, 117, 156, and 234 mg of paliperidone palmitate are equal to 25, 50, 75, 100, and 150 mg eq., respectively.

FORMULATION

INVEGA SUSTENNA is an aqueous extended-release suspension that uses nano-particle technology.⁶ Paliperidone is joined with palmitic acid through an ester linkage.⁶ Paliperidone palmitate particles are dispersed in an aqueous suspension and transformed into smaller paliperidone palmitate nano-particles through particle-size reduction.⁶ Nano-particles have a greater surface area than the larger original particles which results in greater water solubility. Following administration, free paliperidone is slowly released through hydrolysis by esterases in the muscle. Paliperidone is then absorbed into the systemic circulation. Nano-particles allow for rapid achievement of paliperidone concentrations without the need for oral supplementation.

DOSAGE AND ADMINISTRATION

For patients who have never taken oral paliperidone or oral or injectable risperidone, it is recommended to establish tolerability with oral paliperidone or oral risperidone prior to initiating INVEGA SUSTENNA.¹^,³^,⁴ After establishing tolerability, initiate INVEGA SUSTENNA with a dose of 234 mg on treatment day 1 and 156 mg one week later, both administered in the deltoid muscle. Following the second dose, monthly maintenance doses can be administered in either the deltoid or gluteal muscle. For schizophrenia, the recommended monthly maintenance dose is 117 mg. Some patients may benefit from lower or higher maintenance doses within the additional available strengths (39 mg, 78 mg, 156 mg, and 234 mg). For schizoaffective disorder, the recommended monthly maintenance dose range is 78-234 mg.³^,⁵ The 39 mg strength was not studied in the long-term schizoaffective disorder study. Adjustment to the maintenance dose may be made monthly.

Please refer to the Prescribing Information for detailed information regarding the dosage and administration of INVEGA SUSTENNA.

ADVERSE REACTIONS

The most common (at least 5% in any INVEGA SUSTENNA group) and likely drug-related (adverse events for which the drug rate is at least twice the placebo rate) adverse reactions from the double-blind, placebo-controlled trials in subjects with schizophrenia were injection site reactions, somnolence/sedation, dizziness, akathisia, and extrapyramidal disorder.⁴ No occurrences of adverse events reached this threshold in the long-term double-blind, placebo-controlled study in subjects with schizoaffective disorder. In the schizoaffective disorder clinical trial, adverse reactions that occurred more frequently in the INVEGA SUSTENNA than the placebo group (a 2% difference or more between groups) were weight increased, nasopharyngitis, headache, hyperprolactinemia, and pyrexia.⁵

The percentage of subjects who discontinued due to adverse events in the four fixed-dose, double-blind, placebo-controlled schizophrenia trials were similar for INVEGA SUSTENNA- and placebo-treated subjects.¹ The percentage of subjects who discontinued due to adverse events in the open-label period of the long-term study in subjects with schizoaffective disorder was 7.5%.² During the double-blind, placebo-controlled period of that study, the percentages of subjects who discontinued due to adverse events were 5.5% and 1.8% in INVEGA SUSTENNA- and placebo-treated subjects, respectively.³

Please refer to the Prescribing Information for detailed information regarding ADVERSE REACTIONS for INVEGA SUSTENNA.

CLINICAL STUDIES

The efficacy and safety of INVEGA SUSTENNA as monotherapy in the treatment of adults with schizophrenia were assessed in four acute, short-term, fixed-dose studies,⁷^-¹¹ one longer-term maintenance study,¹² and one long-term, open-label, flexible-dose comparator trial with selected oral antipsychotic therapies.¹³

The efficacy and safety of INVEGA SUSTENNA as monotherapy or as adjunctive therapy to a mood stabilizer or antidepressant in the treatment of schizoaffective disorder was assessed in an international, long-term, double-blind, placebo-controlled, randomized-withdrawal maintenance study in adults.⁵^,¹⁴ Table: Paliperidone Palmitate Pivotal Clinical Trial Results provides an overview of paliperidone palmitate clinical studies. The dosing regimen used in the Pandina et al (2010)⁷ clinical trial closely reflects the approved dosing regimen for INVEGA SUSTENNA in schizophrenia.

Paliperidone Palmitate Pivotal Clinical Trial Results

Trial Design	Efficacy and Safety Results
Acute, Short-term Clinical Studies in Schizophrenia
Pandina et al (2010)⁷; Haskins et al (2009)⁸ conducted a 13-week, randomized, double-blind, parallel-group, multicenter, PBO-controlled, dose-response study evaluating three fixed doses of PP1M in patients with schizophrenia (n=636, ITT analysis set) *Dosing Schedule: Following a ≤7-day screening, washout, and tolerability period, patients were randomized to one of three PP1M treatment arms (39, 156, or 234 mg) or to PBO. Patients received initiation doses of 234 mg (all PP1M patients) or PBO on day 1 (deltoid IM injection) followed by their fixed doses or PBO on days 8, 36, and 64 (deltoid or gluteal IM injection). Primary Efficacy*: Mean change in PANSS total score	*Change in PANSS Total Score: PP1M 39 mg (n=155): -8.1 (P<0.05 vs PBO) PP1M 156 mg (n=161): -11.6 (P<0.05 vs PBO) PP1M 234 mg (n=160): -13.2 (P<0.05 vs PBO) PBO (n=160): -2.9 Estimated Effect Size Compared with PBO: PP1M 39 mg: 0.28 PP1M 156 mg: 0.49 PP1M 234 mg: 0.55 Onset of effect was seen as early as day 8 in the PP1M 39- and 234-mg groups and day 22 in the 156-mg group Safety*: Most common treatment-emergent AEs (≥2% in any treatment group) that occurred more frequently (≥1% difference) in the total PP1M group than in the PBO group were injection-site pain (PP1M: 7.6% versus PBO: 3.7%), dizziness (2.5% versus 1.2%), sedation (2.3% versus 0.6%), pain in extremity (1.6% versus 0%), and myalgia (1% versus 0%)
Kramer et al (2010)⁹ conducted a 9-week, double-blind, randomized, international study assessing the safety and efficacy of two fixed PP1M doses compared to PBO in the treatment of schizophrenia (n=247) *Dosing Schedule* Following a 5-day screening/washout phase and a 7-day oral run-in period, patients were randomized to receive gluteal IM injections of PP1M doses (78 or 156 mg) or PBO without oral supplementation on days 1, 8, and 36. *Primary Efficacy*: Mean change in PANSS total score	*Change in PANSS Total Score: PP1M 78 mg (n=63): -5.2 (P=0.001 vs PBO) PP1M 156 mg (n=68): -7.8 (P<0.001 vs PBO) PBO (n=66): 6.2 Onset of effect was observed within 8 days of the first injection for both doses. Safety:* Treatment-emergent AEs were similar between the treatment groups: PBO: 64% PP1M 78 mg: 65% PP1M 156 mg: 60%
Nasrallah et al (2010)¹⁰ conducted a 13-week, multicenter, randomized, double-blind, PBO-controlled, parallel-group, dose-response study evaluating the efficacy and safety of 3 fixed doses of PP1M in patients with schizophrenia (n=514; ITT analysis set) *Dosing Schedule* Following a ≤7-day screening, washout, and tolerability period, patients were randomized to one of three fixed PP1M doses (39, 78, or 156 mg) or PBO administered by gluteal IM injection on days 1, 8, 36, and 64. *Primary Efficacy*: Mean change in PANSS total score	*Change in PANSS Total Score: PP1M 39 mg (n=129): -13.6 (P=0.015 vs PBO) PP1M 78 mg (n=128): -13.2 (P=0.017 vs PBO) PP1M 156 mg (n=131): -16.1 (P<0.001 vs PBO) PBO (n=125): -7.0 Onset of effect was observed at day 36 for all 3 doses Safety*: AEs in at least 5% of patients in any treatment group were similar except for the following: weight increase (4% PP1M versus 0% PBO) somnolence (4% PP1M versus 1% PBO) A higher rate of serious treatment-emergent AEs was reported for PBO-treated patients (18%) than for PP1M-treated patients (8-14%)
Gopal et al (2010)¹¹ conducted a 13-week, multicenter, randomized, double-blind, PBO-controlled, parallel-group, dose-response study evaluating the efficacy and safety of three fixed doses of PP1M in patients with schizophrenia (n=349, primary efficacy analysis set) *Dosing Schedule: Following a washout, screening, and tolerability period that lasted for ≤7 days, patients were randomized to receive one of three fixed doses of PP1M (78, 156, or 234 mg) or PBO administered by gluteal IM injection on days 1, 8, 36, and 64. Primary Efficacy*: Mean change in PANSS total score	*Change from Baseline to Endpoint in PANSS Total Score (LOCF): PP1M 78 mg (n=93): -7.9 (P=0.19 vs PBO) PP1M 156 mg (n=94): -11.0 (P=0.019 vs PBO) PP1M 234 mg (n=30): -5.5 (no P-value vs PBO) PBO (n=132): -4.1 Differences from PBO in LS Mean Change in PANSS Total Score: PP1M 78 mg (n=93): -3.5 (P=0.19 vs PBO) PP1M 156 mg (n=94): -6.9 (P=0.019 vs PBO) PP1M 234 mg (n=30): no statistical comparison performed A significant onset of effect was evident on day 36 with the 156 mg dose. Safety*: AEs occurring more frequently (≥5% difference) with PP1M than with PBO were headache, vomiting, injection-site pain, and pain in extremity
Longer-term Maintenance Study in Schizophrenia
Hough et al (2010)¹² conducted a longer-term, double-blind, randomized, multicenter, PBO-controlled, parallel-group study examining the efficacy and safety of PP1M in the prevention of schizophrenia symptom relapse following an initial 9-week, open-label transition phase and a 24-week, open-label maintenance phase (double-blind phase, n=410) *Dosing Schedule: Following a ≤7-day screening and washout period, patients received gluteal IM injections of PP1M 78 mg on days 1 and 8 of the transition phase followed by adjustable doses of PP1M 39, 78, or 156 mg administered every four weeks for the remainder of the transition phase and for the first 12 weeks of the maintenance phase. Doses remained fixed for the last 12 weeks of the maintenance phase and during the double-blind relapse-prevention phase. Primary Efficacy*: Time to first relapse event (psychiatric hospitalization, deliberate self-injury, suicidal or homicidal ideation, or certain predefined PANSS scores)	*Median Time to Relapse (interim analysis): PP1M: not estimable (P<0.0001 vs PBO) PBO: 163 days Number (%) of relapse events: PP1M: 15/156 (10%) PBO: 53/156 (34%) The study terminated early because of a significant difference in interim results for time to relapse Final analysis: Time to relapse was significantly longer with PP1M than with PBO (P<0.0001) Hazard ratio for PBO versus PP1M (95% CI): 3.60 (2.45 to 5.28) Safety*: Treatment-emergent AEs occurred in 45% of the PBO group and 44% of the PP1M group in the double-blind phase. AEs occurring more frequently (≥2% difference) with PP1M than with PBO included weight increase (7% vs 1%) and blood glucose increase (3% vs 1%). Serious AEs occurred in 13% of PBO and 5% of PP1M patients.
Long-Term Comparative Monotherapy Treatment versus Oral Antipsychotic Therapy
Alphs et al (2015)¹³ compared the time to first treatment failure in a community sample of patients from nontraditional locations (i.e. homeless shelters, soup kitchens, jail-release or diversion programs) with schizophrenia, recently released from incarceration, receiving PP1M once monthly or oAPs daily (N=444). *Study Design/Methods* 15-month, prospective, randomized, open-label, event monitoring board (EMB)-blinded, multicenter US study (PRIDE: Paliperidone Palmitate Research In Demonstrating Effectiveness) designed to reflect real-world schizophrenia patients, treatments and outcomes. Patients could continue participation up to 15 months regardless of reaching primary endpoint or discontinuation of the randomized study drug. Schizophrenia diagnosis confirmed by the Mini International Neuropsychiatric Interview (MINI), version 6.0 Patients were included if they were: Placed into custody ≥2 times within the previous 2 years, with at least one custody leading to incarceration Release from the most recent custody occurred within 90 days of screening Major exclusion criteria included: Use of either clozapine or an injectable antipsychotic within 3 months or 2 injection cycles of screening, respectively. Substance abuse was not exclusionary however, patients abusing intravenous drugs within 3 months of screening or with an opiate dependence disorder were excluded. The clinician and patient reviewed the list of available oAPs (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine and risperidone) before randomization and could preselect up to 6 from the list based on prior experience. Patients were stratified on the basis of their selection of oAP treatments and randomly assigned to flexibly dosed PP1M (78-234 mg) or flexibly dosed oAP therapy. Concomitant use of nonantipsychotic psychotropic medications were permitted. Primary endpoint: Time to first treatment failure, defined as arrest or incarceration; psychiatric hospitalization; suicide; treatment discontinuation due to inadequate efficacy, safety or tolerability; treatment supplementation due to inadequate efficacy; or increase in level of psychiatric services to prevent imminent psychiatric hospitalization. An independent EMB, blinded to patient treatment assignment, certified the occurrence and time of first treatment failure for each patient. Subjects were considered completers if they experienced a treatment failure event or completed the 15-month study follow-up. Efficacy and safety analyses included the ITT population, defined as all randomly assigned patients who received ≥1 dose of study medication.	*Baseline Characteristics* Baseline demographics/clinical characteristics were similar between treatment groups. Most patients were male (86.3%) and black/African American (62.1%). The mean age was 38.1 years, and the mean time since release from last incarceration was 42.2 days. Prior to enrollment, the majority of arrests were for nonviolent crimes or drug offences. A total of 59.5% of patients had comorbid substance abuse. Mean number of psychiatric hospitalizations in a lifetime for PP1M and oAP patients was 7.3 and 5.7, respectively. Mean exposure to PP1M and oAPs was 266.2 and 271.5 days, respectively. Mean doses per refill records were: PP1M: 181.3 (n=226) per injection records ARI: 16.6 mg (n=25) HAL: 7.7 mg (n=11) OLA: 13.2 mg (n=31) PAL: 6.4 mg (n=43) PER: 14.4 mg (n=18) QUE: 335.9 mg (n=24) RIS: 3.4 mg (n=30) *Primary Analysis – Efficacy* Of the 444 patients included in the ITT population, 68.7% (n=305) had an EMB-identified treatment failure or completed the 15-month study, 13.5% (n=60) were lost to follow-up and 9.5% (n=42) withdrew consent. The median time to first treatment failure was significantly longer for PP1M versus oAPs (416 versus 226 days, respectively; P=0.011). Risk of treatment failure was 1.43 times higher for the oAP versus PP1M group (95% CI: 1.09, 1.88). First treatment failures were observed in 39.8% of PP1M and 53.7% of oAP patients Reasons for first treatment failure – PP1M (n=226) vs oAP (n=218): Arrest/incarceration: PP1M=48 (21.2%); oAP=64 (29.4%) Psychiatric hospitalization: PP1M=18 (8.0%); oAP=26 (11.9%) Discontinuation of antipsychotic treatment due to safety or tolerability: PP1M=15 (6.6%); oAP=8 (3.7%) Treatment supplementation with another antipsychotic due to inadequate efficacy: PP1M=5 (2.2%); oAP=6 (2.8%) Discontinuation of antipsychotic treatment due to inadequate efficacy: PP1M=1 (0.4%); oAP=9 (4.1%) Increase in level of psychiatric services to prevent imminent psychiatric hospitalization: PP1M=3 (1.3%); oAP=4 (1.8%) Suicide: PP1M=0; oAP=0 A significantly longer time to first psychiatric hospitalization or arrest/incarceration was observed with PP1M versus oAPs (P=0.019). The risk of first psychiatric hospitalization or arrest/incarceration was 1.43 times higher for the oAP versus PP1M group (95% CI: 1.06, 1.93). *Primary Analysis – Safety* The most frequently reported (>10% of patients in either group) treatment-emergent adverse events (AEs) for the PP1M and oAP groups, respectively were: injection site pain (PP1M only: 18.6%), insomnia (16.8%; 11.5%); weight gain (11.9%; 6%); akathisia (11.1%; 6.9%); anxiety (10.6%; 7.3%) The most common treatment-emergent adverse events for paliperidone palmitate (≥5% and twice active comparator) were: injection site pain and erectile dysfunction TEAEs leading to drug discontinuation occurred in 11.9% and 7.8% of PP1M and oAP patients, respectively. A treatment-emergent prolactin-related AE was reported in 23.5% (n=53) and 4.1% (n=9) of PP1M and oAP patients, respectively. Rates of EPS-related TEAES for the PP1M and oAP groups, respectively were: akathisia (11.1% vs. 6.9%), dyskinesia (2.7% vs. 1.4%), dystonia (2.2% vs. 2.8%) and Parkinsonism (1.8%, each). Weight gain increase ≥7% was observed in 32.4% of PP1M and 14.4% of oAP patients.
Randomized-Withdrawal Maintenance Study in Schizoaffective Disorder
Fu et al⁵^,¹⁴ conducted an international, long-term, double-blind, PBO-controlled, randomized-withdrawal study of PP1M in patients with schizoaffective disorder. *Dosing Schedule: 1-7-day screening period* Oral tolerability testing if necessary 13-week, open-label, lead-in period PP1M (234 mg on day 1 and 156 mg on day 8 in the deltoid muscle, followed by flexible doses [78-234 mg] on days 36, 64, and 92), as monotherapy or as an adjunct to, stable doses of their adjunctive MS or AD medications.¹⁵ 12-week, open-label, fixed-dose phase Patients who met predefined stabilization criteria (PANSS total score ≤70, YMRS total score ≤12, and HAM-D-21 total score ≤12 during the open-label phase are shown) received PP1M once every 4 weeks, at the final dose received during the lead-in period. The last dose of PP1M at the end of the open-label phase was 78 mg in 2.7% of patients, 117 mg in 7.3% of patients, 156 mg in 52.8% of patients, and 234 mg in 37.2% of patients. The mean average dose was similar for patients receiving adjunctive therapy and monotherapy. 15-month, double-blind phase Patients who maintained stability based on predefined criteria were randomized to PBO or a fixed dose of PP1M. PP1M dose distribution: 78 mg (4.9%), 117 mg (9.8%), 156 mg (47%) or 234 mg (38.4%) *Primary Efficacy*: Time to relapse^a.	*Patient Characteristics* 667 patients (mean age: 39.5 years; 53.5% male; 53.1% white) were enrolled in the open-label phase. PP1M was used as monotherapy in 320 patients, and as adjunctive therapy with a mood stabilizer or antidepressant in 347 patients during the open-label phase. 334 patients (mean age: 38.6 years; 50.6% male; 54.8% white) were randomized to PP1M (n=164) or placebo (n=170) in the double-blind phase. 151 patients received monotherapy while 183 patients received adjunctive therapy (MS: 105; AD: 78) *Open-Label* ¹⁴ Significant improvements in mean change from baseline in PANSS total score, CGI-S-SCA overall score, YMRS total score and HAM-D-21 total score from week 1 to week 25/open-label endpoint (P<0.001 for all time points from baseline [week 0]) Treatment-emergent adverse events (TEAEs) occurred in 63.3% of patients. TEAEs occurring in ≥5% of patients included akathisia (10.8%), injection site pain (10.5%), insomnia (10.0%), increased weight (9.1%), parkinsonism (6.6%), headache (5.2%), and suicidal ideation (4.6%). *Double-Blind* ⁵ In the double-blind phase, time to relapse was significantly longer for PP1M versus PBO (P<0.001). Relapse rates were significantly lower for the PP1M versus PBO groups (15.2% [n=25] versus 33.5% [n=57], respectively). Risk of relapse was 2.49-fold higher for PBO versus PP1M (95% CI: 1.55, 3.99; P<0.001). Most common TEAEs (≥5%) for either PP1M or PBO, respectively, were: schizoaffective disorder (3.0%; 5.9%), weight gain (8.5%; 4.7%), nasopharyngitis (5.5%; 3.5%), headache (5.5%; 3.5%), and insomnia (4.9%; 7.1%)
^aRelapse was defined as the first occurrence of: psychiatric hospitalization due to worsening of symptoms; any intervention to avert imminent hospitalization due to worsening of symptoms, clinically significant self-injury, suicidal or homicidal ideation, or violent behaviors; worsening of ≥1 of the following PANSS items to a score ≥6 after randomization if the score was ≤4 at randomization: delusions, conceptual disorganization, hallucinatory behavior, excitement, suspiciousness/persecution, hostility, uncooperativeness or poor impulse control; worsening in any of the following measures at 2 consecutive visits within 7 days: ≥25% increase in PANSS total score from randomization if the score was >45 at randomization, ≥10-point increase in PANSS total score from randomization if the score was ≤45 at randomization, worsening of ≥1 of the following PANSS items to a score ≥5 after randomization if the score was ≤3 at randomization: delusions, conceptual disorganization, hallucinatory behavior, excitement, suspiciousness/persecution, hostility, uncooperativeness or poor impulse control; OR increase in Clinical Global Impression of Severity-Schizoaffective Disorder ([CGI-S-SCA) ≥2 points if the score at randomization was 1 (not ill) to 3 (mildly ill) OR increase ≥1 point if the score at randomization was ≥4 (moderately ill or worse) Abbreviations: AD, antidepressant; AE, adverse event; ARI, aripiprazole; CI, confidence interval; HAL, haloperidol; IM, intramuscular; ITT, intent-to-treat; LOCF, last observation carried forward; LS, least-squares; MS, mood stabilizer; oAP, oral antipsychotics; OLA, olanzapine; PAL, paliperidone; PP1M, paliperidone palmitate 1-month; PANSS, Positive and Negative Syndrome Scale; PBO, placebo; PER, perphenazine; QUE, quetiapine; RIS, risperidone

other relevant literature

A 49-week, prospective, randomized, active-controlled trial evaluating the long-term effect of INVEGA SUSTENNA vs oral antipsychotics in patients with schizophrenia at risk for violent behavior (exhibiting destructive behavior or engaging in violent acts towards property or individuals within the past year) reported significant improvement in the risk assessment scores for aggressive behavior and psychopathological symptoms in the INVEGA SUSTENNA group with the identification of no additional safety signals.¹⁶
The European Long-acting Antipsychotics in Schizophrenia Trial (EULAST) was a randomized, open-label trial conducted in patients with early-phase schizophrenia (6 months to 7 years before screening) to compare antipsychotic long-acting injectables (LAIs) vs their oral equivalent medication. No significant differences in all-cause discontinuation or hospitalizations were reported over a 19-month follow-up period between antipsychotic LAIs, including INVEGA SUSTENNA, and oral antipsychotics.¹⁷

LITERATURE SEARCH

A literature search of MEDLINE^® (and/or other resources including internal/external databases) pertaining to this topic was conducted on 01 March 2024.

Post-hoc analyses and review articles on paliperidone palmitate have not been included in this response.

References

Show

1	Carter NJ. Extended-release intramuscular paliperidone palmitate: a review of its use in the treatment of schizophrenia. Drugs. 2012;72(8):1137-1160.
2	Alphs L, Fu DJ, Turkoz I. Paliperidone for the treatment of schizoaffective disorder. Expert Opin Pharmacother. 2016;17(6):871-883.
3	Greenberg WM, Citrome L. Paliperidone palmitate for schizoaffective disorder: a review of the clinical evidence. Neurol Ther. 2015;4(2):81-91.
4	Citrome L. New second-generation long-acting injectable antipsychotics for the treatment of schizophrenia. Expert Rev Neurother. 2013;13(7):767-783.
5	Fu DJ, 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.
6	Bishara D, Taylor DM. Paliperidone palmitate - a new long-acting injection for schizophrenia. Br J Clin Pharmacol. 2011;3:75-78.
7	Pandina GJ, Lindenmayer JP, Lull J, et al. A randomized placebo-controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia. J Clin Psychopharmacol. 2010;30(3):235-244.
8	Haskins JT, Sliwa JK, Ma Y-W, et al. Efficacy and safety of 234 mg initiation dose and 3-fixed maintenance doses of paliperidone palmitate-a once-monthly injectable atypical antipsychotic. Poster presented at: the US Psychiatric and Mental Health Congress; November 2-5, 2009; Las Vegas, NV.
9	Kramer M, Litman R, Hough D, et al. Paliperidone palmitate, a potential long-acting treatment for patients with schizophrenia. Results of a randomized, double-blind, placebo-controlled efficacy and safety study. Int J Neuropsychopharmacol. 2010;13(5):635-647.
10	Nasrallah HA, Gopal S, Gassmann-Mayer C, et al. A controlled, evidence-based trial of paliperidone palmitate, a long-acting injectable antipsychotic, in schizophrenia. Neuropsychopharmacology. 2010;35(10):2072-2082.
11	Gopal S, Hough DW, Xu H, et al. Efficacy and safety of paliperidone palmitate in adult patients with acutely symptomatic schizophrenia: a randomized, double-blind, placebo-controlled, dose-response study. Int Clin Psychopharmacol. 2010;25(5):247-256.
12	Hough D, Gopal S, Vijapurkar U, et al. Paliperidone palmitate maintenance treatment in delaying the time-to-relapse in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. Schizophr Res. 2010;116(2-3):107-117.
13	Alphs L, Benson C, Cheshire-Kinney K, et al. Real-world outcomes of paliperidone palmitate compared to daily oral antipsychotic therapy in schizophrenia: a randomized, open-label, review board-blinded 15-month study. J Clin Psychiatry. 2015;76(5):554-561.
14	Fu DJ, Turkoz I, Simonson RB, et al. Paliperidone palmitate long-acting injectable in acute exacerbation of schizoaffective disorder. Poster presented at: the 14th International Congress on Schizophrenia Research; April 21-25, 2013; Orlando, FL.
15	Fu DJ, Turkoz I, Simonson R, et al. Paliperidone palmitate long-acting injectable for treating acute exacerbation of schizoaffective disorder. Poster presented at: The 25th Annual US Psychiatric and Mental Health Congress; November 8-11, 2012; San Diego, CA.
16	Wang G, Huang H, Wang Y, et al. A randomized, prospective, active-controlled study comparing intramuscular long-acting paliperidone palmitate versus oral antipsychotics in patients with schizophrenia at risk of violent behavior. Prog Neuropsychopharmacol Biol Psychiatry. 2024;129:110897.
17	Winter-van Rossum I, Weiser M, Galderisi S, et al. Efficacy of oral versus long-acting antipsychotic treatment in patients with early-phase schizophrenia in Europe and Israel: a large-scale, open-label, randomised trial (EULAST). Lancet Psychiatry. 2023;10(3):197-208.