INVEGA SUSTENNA®
(paliperidone palmitate)
Medical inquiries
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INVEGA SUSTENNA® (paliperidone palmitate)
Medical Information
Background and Conversion from ERZOFRI®
Last Updated: 02/14/2025
Summary
- ERZOFRI is a once-monthly paliperidone palmitate injection for the treatment of adults with schizophrenia and as a monotherapy or adjunct therapy for the treatment of adults with schizoaffective disorder.1
- ERZOFRI was approved via the 505(b)(2) pathway2
, which allows for the use of pre-existing data in the approval process for products that are not considered new or different.3 - ERZOFRI was approved based on an open-label, randomized, multiple-dose, parallel-group pharmacokinetic study comparing the bioavailability of ERZOFRI and INVEGA SUSTENNA (NCT04922593), and the clinical trial data for INVEGA SUSTENNA
- ERZOFRI is not a generic medication. It is a branded medication and is not considered substitutable for INVEGA SUSTENNA according to the FDA Orange book.4
- ERZOFRI and INVEGA SUSTENNA have the same active ingredient, paliperidone palmitate.1,
5 - Under the 505(b)(2) pathway, the FDA assumes that the efficacy and safety of the two medications will be similar, therefore no head-to-head trials comparing the clinical outcomes of these medications is required.3
- ERZOFRI has a different initiation protocol than INVEGA SUSTENNA
- Patients currently treated with ERZOFRI can be transitioned to INVEGA SUSTENNA at the next scheduled injection5
- Patients who are adequately treated on ERZOFRI for at least 4 months, at an appropriate dose (with the last 2 dose being the same strength), can transition to INVEGA TRINZA or INVEGA HAFYERA6
,7 - For information about ERZOFRI, please reach out to Luye Pharma
Background
ERZOFRI is a monthly paliperidone palmitate injection developed by Luye Pharma, an international pharmaceutical company headquartered in Hong Kong, that received FDA approval on July 28, 2024 via the 505(b)(2) pathway.2 The 505(b)(2) process allows for the approval of drugs that are not considered new or different by using existing clinical data.3 ERZOFRI was approved based on an open-label, randomized, multiple-dose, parallel-group pharmacokinetic study comparing the bioavailability of ERZOFRI and INVEGA SUSTENNA (NCT04922593), and the clinical trial data for INVEGA SUSTENNA.1 ERZOFRI is a branded medication and is not considered a generic medication. Based on the FDA orange book, ERZOFRI is not substitutable for INVEGA SUSTENNA.4
- ERZOFRI and INVEGA SUSTENNA have the same active ingredient, paliperidone palmitate.1,5 Under the 505(b)(2) pathway, the FDA assumes that the efficacy and safety of the two medications will be similar, therefore no head-to-head trials comparing the clinical outcomes of these medications is required.3 The pharmacokinetic study evaluating bioavailability conducted by Luye Pharma revealed the following profile for ERZOFRI compared to INVEGA SUSTENNA. Table: PK Parameters of ERZOFRI and INVEGA SUSTENNA based on the Luye Pharma bioequivalence study
| PK Parameter | ERZOFRI | INVEGA SUSTENNA | ||
|---|---|---|---|---|
| GLS Mean (Initiation through 6 consecutive injections) | GLS Mean (Steady State) | GLS Mean (Initiation through 7 consecutive injections) | GLS Mean (Steady State) | |
| Ctrough (ng/mL) | 28.5 | 28.3 | 30.1 | 30.4 |
| Cmax (ng/mL) | 43.7 | 42.6 | 58.7 | 43.8 |
| Cavg (ng/mL) | 30.3 | - | 37.8 | - |
| AUCTau (ng*h/mL) | - | 909 | - | 953 |
| Abbreviations: AUCTau, area under the plasma concentration-time curve within the interval of 28 days after the injection; Cavg, observed average plasma concentration; Cmax, observed maximum plasma concentration; Ctrough, observed minimum plasma concentration; GLS, geometric least square. | ||||
Coppola et al (2012)8
| PK Parameter | 2nd | 8th | 14th Injection | |||
|---|---|---|---|---|---|---|
| n | Median (min-max) | n | Median (min-max) | n | Median (min-max) | |
| Cmin (ng/mL) | 189 | 17.0 (0.46-46.7) | 114 | 27.0 (6.03-92.6) | 105 | 35.1 (9.17-120) |
| Cmax (ng/mL) | 189 | 50.5 (11.5–232) | 114 | 50.5 (10.7–172) | 105 | 56.5 (17.6–172) |
| tmax (days) | 189 | 7.96 (0.00–28.02) | 114 | 8.48 (0.00–30.95) | 105 | 7.00 (0.00–30.00) |
| AUCT (ng*h/mL) | 183 | 23325 (3652–86457) | 111 | 26831 (6335–87393) | 105 | 31970 (9244–96840) |
| FI (%) | 183 | 92.7 (39.8–215) | 114 | 55.0 (15.6–179) | 105 | 41.2 (5.83–111) |
| Abbreviations: AUCT, area under the plasma concentration-time curve within the interval of 28 days after the injection; Cmax, observed maximum plasma concentration; FI, fluctuation index of the plasma concentrations; tmax, time to reach observed maximum plasma concentration, calculated in hours and recalculated to days. | ||||||
Conversion From ERZOFRI
- ERZOFRI uses a different initiation protocol than INVEGA SUSTENNA.1,5
- Patients currently treated with ERZOFRI can be transitioned to INVEGA SUSTENNA at the next scheduled injection.5 Patient who are adequately treated on ERZOFRI for at least 4 months, at an appropriate dose (with the last 2 dose being the same strength), can transition to INVEGA TRINZA or INVEGA HAFYERA at the next scheduled injection.6,7
References
| 1 | ERZOFRI (paliperidone palmitate) extended-release injectable suspension [Prescribing Information]. Yantai, China: Luye Pharma:https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216352s000lbl.pdf |
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