Perseris (risperidone sustained-release 1-month depot) / Indivior, Reckitt Benckiser, HLS Therap - LARVOL DELTA

Switching patients with schizophrenia from RBP-7000, a subcutaneous, once-monthly risperidone, to TV-46000, a long-acting subcutaneous antipsychotic: population pharmacokinetic–based strategies (ECNP 2024) - "PopPK simulations revealed switching to TV-46000 4 weeks after the last dose of RBP-7000 provided generally comparable PK exposures at first dose and at steady state of TV-46000. If clinicians seek to avoid higher Cmax peaks associated with switching to TV-46000 q2m, then q1m can be administered. Clinician discretion will determine whether to initiate q1m or q2m TV-46000 4 weeks after the last dose of RBP-7000 based on a variety of factors, such as patient preference, scheduling convenience, and concerns about tolerability or symptom breakthrough."

Clinical • PK/PD data • CNS Disorders • Psychiatry • Schizophrenia

Towards in vitro - In vivo correlation models for in situ forming drug implants. (PubMed, J Control Release) - "The predictability of the model passed external validation using the reference listed drug (RLD), Perseris®. IVIVC could not be developed when formulations with different PLGA molar ratios of lactic acid to glycolic acid (L/G) were included. The present work provides a comprehensive understanding of the impact of the testing method attributes on drug release from in situ forming implants, which is a valuable practice for level A IVIVC development."

Journal • Preclinical

An Open-Label Study to Assess Monthly Risperidone Injections (180 mg) Following Switch from Daily Oral Risperidone (6 mg) in Stable Schizophrenic Patients. (PubMed, Clin Drug Investig) - P4 | "The results support the use of 180 mg RBP-7000 in schizophrenic patients stable on 6 mg/day oral risperidone and a second injection site in the upper arm."

Journal • CNS Disorders • Psychiatry • Schizophrenia

In brief: Three new injectable antipsychotic drugs. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry • Schizophrenia

In situ forming risperidone implants: Effect of PLGA attributes on product performance. (PubMed, J Control Release) - "Perseris (risperidone) for extended-release injectable suspension was selected as the reference listed drug (RLD)...This is the first report evaluating the impact of PLGA property variation (over a narrow range) on the performance of in situ forming implants. The knowledge gained will provide a better understanding of the mechanisms underlying risperidone in situ forming implant performance and will aid the development of future products."

Journal

In Vivo Characterization of Perseris and Compositionally Equivalent Formulations. (PubMed, Int J Pharm) - "Although the erosion mechanism appeared to be similar between in vitro and in vivo, there were in vitro-in vivo differences concerning the drug release kinetics, phase separation rates and swelling behavior. This work provides a comprehensive in vitro/in vivo understanding of Perseris and the developed compositionally equivalent formulations, which will be beneficial for future development of generic as well as novel PLGA in situ forming implant products."

Journal • Preclinical • CNS Disorders • Psychiatry • Schizophrenia

Evaluation of Patient Assistance Programs and Eligibility Criteria Offered for Long-Acting Antipsychotics Used in Patients With Schizophrenia (APA 2023) - "Of those, 70% (8/10) offer a PAP which covers the full cost for uninsured US residents, including: Abilify Maintena, Abilify Aristada, Invega Sustenna, Invega Trinza, Invega Hayfera, Risperdal Consta and Haldol Decanoate. With LAI’s such as Zyprexa Relprevv, Prolixin and Perseris being the exceptions... While these PAP’s cover the entirety of the cost of most of the available medications for those without insurance, they only aid a small subset of the population of patients suffering from schizophrenia. Efforts will need to be made to decrease the gap between costs of treatment and available financial assistance programs, especially for those expereincing financial difficulty who have some form of medical insurance and high copayments."

Clinical • CNS Disorders • Psychiatry • Schizophrenia

Reverse Engineering of Perseris and Development of Compositionally Equivalent Formulations. (PubMed, Int J Pharm) - "The novelty of this dissolution method lies in its ability to control implant shape, generate reproducible data, distinguish different release phases, as well as identify formulation changes. The knowledge gained in this work and the methodology established for characterization of the implant formulations are important for implant formulation development."

Journal

PANSS Individual Item and Marder Dimension Analyses From a Pivotal Trial of RBP-7000 (Monthly Extended-Release Risperidone) in Schizophrenia Patients. (PubMed, J Clin Psychiatry) - P3 | "Schizophrenia patients with higher baseline Marder UHE scores may benefit from initiation of treatment at the 120 mg dose. Trial Registration: ClinicalTrials.gov identifier: NCT02109562."

Clinical • Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry • Schizophrenia

Perseris Kit: Newly added patent in Orange Book (Orange Book) - Expiry on November 5, 2026

Patent • Schizophrenia

Perseris: PDUFA action date in US for schizophrenia on December 12, 2021 (Indivior) - H1 2021 Results

PDUFA date • Schizophrenia

Safety, Tolerability, Pharmacokinetics and Efficacy of 180 mg Subcutaneous Risperidone From 6 mg Oral Risperidone (clinicaltrials.gov) - P4; N=69; Completed; Sponsor: Indivior Inc.; N=25 ➔ 69

Clinical • Enrollment change • CNS Disorders • Psychiatry • Schizophrenia

[VIRTUAL] Alternate Injection Site (Back of Upper Arm) for Monthly Long-Acting Risperidone Injections of RBP- 7000 (APA 2021) - "Administration of 180 mg RBP-7000 in the back of the upper arm showed comparable pharmacokinetics compared with injection in the abdominal region with no clinically meaningful differences in safety or efficacy measures, supporting the back of the upper arm as an alternative injection site."

CNS Disorders • Dermatology • Pain • Psychiatry • Schizophrenia

[VIRTUAL] RBP-7000 Monthly Risperidone Injection (180 Mg) Following Switch From Daily Oral Risperidone (6 Mg) in Stable Schizophrenic Patients (APA 2021) - "Monthly injections of 180 mg RBP-7000 administered as 2 SC injections of 90 mg provided similar average plasma concentration of the total active moiety compared with 6 mg/day oral risperidone given as 3 mg twice daily. All clinical symptoms assessments remained stable throughout the study prior to and after the switch from oral risperidone. Overall, the safety profile of 180 mg RBP-7000 was consistent with the established safety profile of RBP-7000 at lower doses and other risperidone products."

Clinical • CNS Disorders • Psychiatry • Schizophrenia

[VIRTUAL] A Comparison of the Pharmacokinetics, Efficacy, and Tolerability of Long-Acting Injectable Risperidone Formulations (CPNP 2021) - "Purpose: The purpose of this review was to compare the pharmacokinetics, efficacy, and tolerability of long-acting injectable risperidone formulations: Risperdal Consta®, PerserisTM, and Risperidone ISM®. Oral antipsychotics are the backbone of schizophrenia treatment in the U.S. Long-acting injectable risperidone continues to be a mainstay of therapy due to improved adherence and efficacy rates. Consta® could be considered first-line because it is well-tolerated, offers more potential for an individualized dosing regimen, and has the greatest PANSS score reduction. As new formulations gain FDA-approval, it is essential that prescribers engage in multifactorial decision-making centered around each individual's needs."

Clinical • PK/PD data • CNS Disorders • Psychiatry • Schizophrenia

HLS Therapeutics Announces Fourth Quarter and Fiscal 2020 Financial Results (Canada Newswire) - "PERSERIS and the MyCare Psychiatry Lab Assays are products in the CNS therapeutic market, and both were approved by Health Canada in Q4....We expect to have both in the market in the second half of 2021."

Launch Canada • CNS Disorders • Schizophrenia

UPDATE 2-Drugmaker Indivior prepares for pandemic hit to run into 2021 (Reuters) - "It expects...Perseris net revenue of $17 million to $20 million."

Sales projection • CNS Disorders • Schizophrenia

Safety, Tolerability, Pharmacokinetics and Efficacy of 180 mg Subcutaneous Risperidone From 6 mg Oral Risperidone (clinicaltrials.gov) - P4; N=25; Completed; Sponsor: Indivior Inc.; N=69 ➔ 25

Clinical • Enrollment change • CNS Disorders • Psychiatry • Schizophrenia

Indivior : Provides Preliminary FY 2020 Financial Results Ahead of Guidance (Market Screener) - "Expected PERSERIS® net revenue consistent with guidance of $12m to $15m."

Sales • CNS Disorders • Schizophrenia

[VIRTUAL] Comparison of the pharmacokinetics, efficacy, and tolerability of long-acting injectable risperidone formulations (ASHP 2020) - "Purpose: The purpose of this review was to compare the pharmacokinetics, efficacy, and tolerability of long-acting injectable risperidone formulations: Risperdal Consta®, PerserisTM, and Risperdal ISM®. Oral antipsychotics are the backbone of schizophrenia treatment in the U.S. Recently, long-acting injectable risperidone formulations are gaining popularity due to improved adherence and subsequent efficacy rates. Risperdal Consta could be considered first-line when a long-acting injectable antipsychotic is warranted because it is well-tolerated, offers the most potential for an individualized dosing regimen, and has the greatest PANSS score reduction. As new formulations gain FDA-approval and become potential therapy options, it is essential that prescribers engage in multifactorial decision-making centered around each individual’s needs regarding administration, adverse effect profiles, drug cost, and other barriers not outlined in this report."

Clinical • PK/PD data • CNS Disorders • Psychiatry • Schizophrenia

Reanalysis of a Phase 3 Trial of a Monthly Extended-Release Risperidone Injection for the Treatment of Acute Schizophrenia. (PubMed, J Clin Psychopharmacol) - No abstract available

Journal • P3 data • CNS Disorders • Psychiatry • Schizophrenia

HLS Therapeutics Announces Health Canada Approval of PERSERIS for the Treatment of Schizophrenia (Canada Newswire) - "HLS Therapeutics Inc....announces that Health Canada has approved the use of PERSERIS® (risperidone for extended-release injectable suspension), 90 mg and 120 mg subcutaneous injection, a novel long-acting injectable of risperidone, for the treatment of schizophrenia in adults. HLS has in-licensed the exclusive rights to PERSERIS for the Canadian market from Indivior PLC (LON: INDV)."

Canadian regulatory • CNS Disorders • Schizophrenia

Association between discontinuation due to withdrawal of consent and use of long-acting injectable antipsychotics: A meta-analysis of randomized trials for schizophrenia. (PubMed, J Psychiatr Res) - "The average DWC of each LAI-AP was as follows: LAI-aripiprazole = 10.98%, LAI-fluphenazine = 7.65%, LAI-flupenthixol = 3.33%, LAI-haloperidol = 6.71%, LAI-olanzapine = 10.50%, LAI-paliperidone = 10.38%, LAI-perphenazine = 7.06%, LAI-risperidone = 10.39%, LAI-zuclopenthixol = 4.45%, pooled LAI-APs = 9.88%, and placebo = 11.17%. LAI-AP use was unlikely to be associated with DWC. Although the LAI-aripiprazole had a higher DWC than did the placebo, its average DWC was similar to other those of LAI-APs."

Journal • Retrospective data • CNS Disorders • Psychiatry • Schizophrenia

Objective and subjective benefits of a psychiatric pharmacist-led long-acting injectable medication training at a large, multisite organization. (PubMed, Ment Health Clin) - "Ninety-five percent of participants selected that they were very satisfied with the training, 88% selected they would definitely use the information presented in their work, and 93% selected that they had a lot of confidence in the topic after the training. A psychiatric LAI medication training administered to nursing staff and medical assistants improved knowledge scores and was perceived as being useful."

Clinical • Journal • CNS Disorders • Pain • Psychiatry

Indivior Takes Strategic Alignment Actions (BioSpace) - "Reorganizing and reinvesting in the U.S. commercial function in-line with the continued penetration and growth of SUBLOCADE® (buprenorphine extended-release) Injection in the Organized Health System (OHS) channel and to facilitate expansion of PERSERIS® (risperidone) extended release injection into the OHS channel. This includes hiring and redirecting some employees to further our progress in this channel. Further focusing of R&D on post-marketing studies to support SUBLOCADE® and PERSERIS®..."

Clinical • Commercial • CNS Disorders • Schizophrenia