(paliperidone palmitate 6-month)
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Last Updated: 05/26/2024
Doses of paliperidone palmitate extended-release injectable suspension may be expressed in mg eq. of paliperidone (active moiety) or mg of paliperidone palmitate. Dosage information in this response has been converted to mg of paliperidone palmitate to reflect the commercially available dosage strengths in United States. The conversion factor from mg eq. to mg is 1.56.
Abbreviations: CGI-S, Clinical Global Impression-Severity; D, deltoid; DSM-5, Diagnostic and Statistical Manual of Mental Disorders, fifth edition; G, gluteal; NMS, neuroleptic malignant syndrome; PANSS, Positive and Negative Syndrome Scale; PP1M, paliperidone palmitate 1-month; PP3M, paliperidone palmitate 3-month; PP6M, paliperidone palmitate 6-month; PSP, Personal and Social Performance; R, randomization; TD, tardive dyskinesia.
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The mean duration of exposure during the DB phase was 329.8 days at a mean dose of 1,335 mg and 336.4 days at a mean dose of 690 mg for INVEGA HAFYERA and INVEGA TRINZA, respectively.1 The incidence of EPS-related treatment-emergent adverse events (TEAEs) was similar for patients treated with moderate or high doses of INVEGA HAFYERA (1,092 mg: 9.3% and 1,560 mg: 10.0%) as determined by dose level at the end of the maintenance phase.
During the DB phase the overall frequency of EPS-related TEAEs was similar for INVEGA HAFYERA and INVEGA TRINZA (9.6% and 8.5%, respectively) with the most common events in both treatment groups being categorized under parkinsonism (INVEGA HAFYERA: 5.0%; INVEGA TRINZA: 3.6%) and akathisia (INVEGA HAFYERA: 3.6%; INVEGA TRINZA: 3.6%).9
None of the EPS-related TEAEs were serious. During the DB phase, 1 case of treatment-emergent parkinsonism in the INVEGA HAFYERA group (0.2%) led to study drug discontinuation. One TEAE of tardive dyskinesia was reported in the INVEGA HAFYERA group (0.2%) in the DB phase; this event was not serious, nor did it lead to study drug discontinuation.9
Open-Label | Double-Blind | ||
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INVEGA SUSTENNA INVEGA TRINZA (N=838) n (%) | INVEGA TRINZA (N=224) n (%) | INVEGA HAFYERA (N=478) n (%) | |
Hyperkinesiaa | 25 (3.0) | 8 (3.6) | 17 (3.6) |
Dyskinesiab | 11 (1.3) | 2 (0.9) | 8 (1.7 |
Dystoniac | 3 (0.4) | 2 (0.9) | 5 (1.0) |
Parkinsonismd | 28 (3.3) | 8 (3.6) | 24 (5.0) |
Tremor | 2 (0.2) | 0 | 1 (0.2) |
aHyperkinesia includes akathisia, restless legs syndrome, and restlessness. bDyskinesia includes muscle twitching and tardive dyskinesia. cDystonia includes muscle spasms, oculogyric crisis, and blepharospasm. dParkinsonism includes bradykinesia, drooling, hypokinesia, muscle rigidity, musculoskeletal stiffness, parkinsonism, parkinsonian rest tremor, and reduced facial expression. |
During the DB phase, both INVEGA TRINZA and INVEGA HAFYERA had similar rates of treatment-emergent EPS symptoms assessed by use of anticholinergic medication (INVEGA HAFYERA: 15.5%; INVEGA TRINZA: 12.9%) and rating scales.1 See Table: EPS Assessed by Use of Anticholinergic Medication and Rating Scale Incidence During the DB Phase
INVEGA TRINZA (%) N=224 | INVEGA HAFYERA (%) N=478 | |
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Use of Anticholinergic Medications | 12.9 | 15.5 |
Parkinsonismb | 6.3 | 6.5 |
Akathisiac | 2.7 | 2.9 |
Dyskinesiad | 1.3 | 1.0 |
aUse of Anti-EPS Medication During the Double-blind Phase. bPercent of patients with Simpson-Angus Scale (SAS) Global Score >0.3 (Global Score defined as total sum of items score divided by the number of items). cPercent of patients with Barnes Akathisia Rating Scale (BARS) Global Clinical Rating Score ≥2. dPercent of patients with a score ≥3 on any of the first 7 items or a score ≥2 on 2 or more of any of the first 7 items of the Abnormal Involuntary Movement Scale (AIMS). |
N | INVEGA TRINZA | N | INVEGA HAFYERA | |
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AIMS Total Score | ||||
Median (Range) Change from Baseline | 221 | 0.0 (-3;2) | 477 | 0.0 (-7;14) |
BARS Global Clinical Rating of Akathisia (DB Baseline), n (%) | ||||
Absent | 224 | 218 (97.3) | 478 | 453 (94.8) |
Questionable | 224 | 6 (2.7) | 478 | 16 (3.3) |
Mild Akathisia | 224 | 0 (0.0) | 478 | 9 (1.9) |
Moderate Akathisia | 224 | 0 (0.0) | 478 | 0 (0.0) |
Marked Akathisia | 224 | 0 (0.0) | 478 | 0 (0.0) |
Severe Akathisia | 224 | 0 0(.0) | 478 | 0 (0.0) |
BARS Global Clinical Rating of Akathisia (DB Endpoint), n (%) | ||||
Absent | 221 | 212 (95.9) | 477 | 451 (94.5) |
Questionable | 221 | 7 (3.2) | 477 | 19 (4.0) |
Mild Akathisia | 221 | 2 (0.9) | 477 | 6 (1.3) |
Moderate Akathisia | 221 | 0 (0.0) | 477 | 1 (0.2) |
Marked Akathisia | 221 | 0 (0.0) | 477 | 0 (0.0) |
Severe Akathisia | 221 | 0 (0.0) | 477 | 0 (0.0) |
SAS Global Score | ||||
Mean (Range) Change from Baseline | 220 | 0.0 (-1;2) | 477 | 0.0 (-1;2) |
Key: AIMS: Abnormal Involuntary Movement Scale; BARS: Barnes Akathisia Rating Scale; SAS: Simpson-Angus Scale. |
Giron-Hernandez et al (2023)3 reported the results of a post hoc subgroup analysis of the noninferiority study that evaluated 384 patients with schizophrenia who were enrolled in European investigational sites and received INVEGA TRINZA (n=124) or INVEGA HAFYERA (n=260). In the DB phase, akathisia, parkinsonism, and dyskinesia were reported in 3 (2.4%), 1 (0.8%), and zero patients, respectively, in the INVEGA TRINZA group, and 8 (3.1%), 4 (1.5%), and 4 (1.5%) patients, respectively, in the INVEGA HAFYERA group.
Richarz et al (2023)4 reported the results of a post hoc analysis of the Asian subgroup enrolled in the noninferiority study. Ninety patients were evaluated in this subgroup (INVEGA TRINZA, n=28; INVEGA HAFYERA, n=62). In the DB phase, parkinsonism and akathisia were reported in 1 (3.6%) and 3 (10.7%) patients in the INVEGA TRINZA group, respectively, and 6 (9.7%) and 2 (3.2%) patients in the INVEGA HAFYERA group, respectively.
Najarian et al (2023)5 conducted a 2-year, single-arm, OLE study to evaluate the long-term safety, efficacy, and tolerability of INVEGA HAFYERA in 178 patients who remained relapse-free in the DB study and elected to continue treatment with INVEGA HAFYERA in the OLE phase. Data was reported separately for patients who were treated with either INVEGA TRINZA (n=57) or INVEGA HAFYERA (n=121) in the DB phase before transitioning to INVEGA HAFYERA in the OLE phase. Tremor was reported in 1.7% (3/178) of the patients on INVEGA HAFYERA during the OLE phase.
A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 25 April 2024.
1 | Najarian D, Sanga P, Wang S, et al. A randomized, double-blind, multicenter, noninferiority study comparing paliperidone palmitate 6-month versus the 3-month long-acting injectable in patients with schizophrenia. Int J Neuropsychopharmacol. 2022;25(3):238-251. |
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