Risperdal Consta (risperidone depot formulation) / J&J - LARVOL DELTA

Population Pharmacokinetic-Based Strategies for Switching Patients with Schizophrenia Between Long-Acting Injectable Formulations of Risperidone: R064766 or RBP-7000 to TV-46000. (PubMed, Neurol Ther) - "These simulations revealed switching to TV-46000 4-6 weeks after the last dose of R064766 and 4 weeks after the last dose of RBP-7000 provided generally comparable PK exposures at first dose and steady state of TV-46000. Clinician discretion will determine which switching strategy is most appropriate in context based on factors such as patient preference, scheduling convenience, and concerns about tolerability."

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

6-month follow-up of adolescents at clinical high risk for psychosis (ECNP 2025) - "The patient received risperidone 2 mg, fluoxetine 20 mg and CBT...Treatment included aripiprazole 5 mg and CBT... This case series illustrates the heterogeneity of clinical trajectories among adolescents at CHR for psychosis and underscores the necessity of individualized, early intervention strategies(3). Comorbidities such as OCD and MDD are common and may influence both symptom presentation and treatment outcomes(4). The limited treatment response observed in the third case appears to align with previous findings suggesting that the severity of negative symptoms may adversely impact treatment outcomes in individuals at CHR (5).While CBT combined with low-dose antipsychotics or SSRIs can yield meaningful improvements in symptoms and functioning, outcomes vary and highlight the importance of sustained monitoring and tailored care."

Clinical • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Obsessive-Compulsive Disorder • Psychiatry • Schizophrenia

Prescribing patterns of antipsychotic monotherapy and polypharmacy in patients with psychotic disorders (ECNP 2025) - "Among monotherapy patients, olanzapine was most frequently prescribed (33.3%), followed by risperidone and haloperidol (both 18.2%), quetiapine (15.2%), aripiprazole (9.1%), and clozapine (6.1%)...Less frequently prescribed in polytherapy were aripiprazole (10.4%), risperidone (7.3%), levomepromazine and zuclopenthixol (both 6.3%), fluphenazine (4.2%), and amisulpride and sulpiride (both 1.0%)... Despite guideline recommendations that advocate for antipsychotic monotherapy whenever possible [1,3], this study found that polypharmacy remains prevalent in clinical practice. Olanzapine emerged as the most common choice in monotherapy regimens, while haloperidol and promazine were more frequently used in polytherapy. Clozapine, despite its well-established role in treatment-resistant schizophrenia, was more commonly prescribed as part of combination therapy (16.7%) than as monotherapy (6.1%)."

Clinical • Monotherapy • CNS Disorders • Psychiatry • Schizophrenia

Dissociative amnesia and brief psychotic disorder comorbidity: a long-term clinical follow-up case analysis (ECNP 2025) - "Initial treatment involved intramuscular haloperidol (10 mg/day) and biperiden (4 mg/day) for four days...Maintenance treatment included oral risperidone (6 mg/day), monthly intramuscular risperidone (Risperdal Consta 25 mg), lamotrigine (up to 400 mg/day), sertraline (100 mg/day), and lithium (1200 mg/day)...A holistic, continuous approach addressing biological, psychological, and social factors is essential to improve functioning and prevent chronic disability. Keywords: dissociative amnesia; brief psychotic disorder; psychosocial stressors; electroconvulsive therapy (ECT); long-term follow-up"

Clinical • Bipolar Disorder • CNS Disorders • Cognitive Disorders • Depression • Mood Disorders • Psychiatry

Risperidone ISM injection in the acute setting for actively psychotic patients with schizophrenia: Case reports (ECNP 2025) - "His aripiprazole was changed to oral liquid risperidone 4 mg daily administered under close supervision...Moreover, as plasma levels equivalent to the oral doses of risperidone are rapidly achieved, Risperidone ISM facilitates the transition from oral to long-acting antipsychotic treatment and is therefore likely to reduce duration of hospital admissions, a hypothesis that warrants further scrutiny. Conflict of interest: Disclosure statement: The authors have participated in an international non-interventional prospective study sponsored by ROVI that evaluated Risperidone ISM"

Case report • Clinical • CNS Disorders • Cognitive Disorders • Psychiatry • Schizophrenia

Revisiting risperidone: new formulations - new futures? (ECNP 2025) - "In clinical practice it has since been largely replaced by other atypical LAIs subsequently developed that include paliperidone (monthly, three-monthly, six-monthly), olanzapine (two-weekly, monthly) and aripiprazole (monthly, two-monthly)...These include risperidone subcutaneous monthly (Perseris) [2] risperidone subcutaneous one or two-montly (Uzedy) [3], risperidone in-situ microspheres (Okedi) [4] and risperidone extended release microspheres (Rykindo) [5]... The new formulations of risperidone LAI overall improve ease of use, increase rapidity of onset, add multiple injection site options and extend treatment duration intervals allowing for greater flexibility, simplicity and patient acceptability in clinical practice. The efficacy and safety profile of risperidone is well established and the new formulations offer the potential of use of a risperidone LAI in a broader range of clinical settings and thus, may improve the use and acceptance of LAIs in both the..."

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

Shares of Lupin Ltd. gained on Wednesday, September 3, said it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Risperidone Injectable. (CNBC-TV18) - "It said it has received USFDA's approval for Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, Single-Dose Vials....Risperidone for extended-release injectable suspension (RLD Risperdal Consta) had estimated annual sales of $190 million in the US, as per IQVIA MAT July 2025."

ANDA • Sales • Bipolar Disorder • Schizophrenia

Clinical Utility of Long-Acting Injectable Risperidone in Schizophrenia and Bipolar I Disorder: A Review of Clinical Studies. (PubMed, Psychol Res Behav Manag) - "To date, five different risperidone LAI formulations have been marketed - including a second biweekly microsphere injection (LY03004), a newer monthly intramuscular formulation using in situ microparticles (ISM) technology that does not require an oral risperidone run-in, and two subcutaneous formulations (RBP-7000 and TV-46000)...To facilitate this, healthcare providers should develop a comprehensive understanding of these formulations to select the most suitable option. While risperidone ISM, RBP-7000, and TV-46000 may enhance treatment feasibility and adherence, further research is needed to build an evidence base comparable to that available for BW-RLAI, particularly in the treatment of BD."

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

Diffusion dimensionality modeling of subcutaneous/intramuscular absorption of antibodies and long-acting injectables. (PubMed, J Pharmacokinet Pharmacodyn) - "The diffusion dimensionality models were challenged with previously published subcutaneous absorption data for 13 antibody drugs and insulin lispro, and the long-acting injectable antipsychotic drugs: subcutaneous Perseris™, intramuscular Invega Sustenna®, Risperdal Consta®, and olanzapine...Three antibodies (CNTO5825, ACE910 and ustekinumab) were best described by the 2-dimensional diffusion equation. The 2- and 3-dimensional diffusion equations were equivalent for ABT981, guselkumab, adalimumab, nemolizumab, omalizumab, and secukinumab. Golimumab, DX2930, AMG139, and mepolizumab were best described by the 3-dimensional diffusion equation. All the long-acting antipsychotic dosage forms except Risperdal Consta were modeled satisfactorily. Diffusion dimensionality models are a parsimonious and effective approach for modeling drug absorption profiles of subcutaneously and intramuscularly administered small molecule and protein drugs and their dosage forms."

Journal • CNS Disorders

Understanding drug release mechanisms of risperidone in situ forming implant depots in rabbits. (PubMed, J Control Release) - "To explore the in vivo drug release mechanisms, risperidone in situ forming implants with different PLGA attributes (i.e., molecular weight (MW), lactide:glycolide (L/G) ratio, blockiness, and end group) were prepared based on the reference listed drug Perseris (risperidone extended-release injectable suspension)...These results indicate that drug release in vivo may be degradation dominated and that depot degradation followed bulk erosion. This study provides an understanding of the in vivo mechanisms controlling drug release from in situ forming implant formulations."

Journal • Preclinical

Real-world outcomes and practice patterns among patients with schizophrenia when switched from oral antipsychotics to long-acting injectable formulations after hospitalization. (PubMed, Psychiatry Res) - "The most prescribed OA and LAI±OA were risperidone (26 %) and haloperidol (37 %), respectively...Prescriptions were based on clinical characteristics at discharge; those prescribed LAIs±OAs may have had less favorable prognoses. However, these results suggest that prescribing second-generation LAIs±OAs with less frequent dosing at discharge may lower rehospitalization risk for patients with schizophrenia."

Journal • Real-world evidence • CNS Disorders • Psychiatry • Schizophrenia

Retrospective cohort study of long-acting injectable (LAI) antipsychotic initiation in the inpatient setting: impact of LAI characteristics on transition and continuation of care among patients with schizophrenia in the USA. (PubMed, BMJ Open) - "Patients prescribed a combination of LAI and OA at discharge had a higher risk of rehospitalisation compared with those prescribed LAI alone. Additionally, the study findings suggest that patients are more likely to be prescribed oral risperidone, the most frequently used second-generation OA, which may support an easier transition to an LAI of the same molecule."

Journal • Retrospective data • CNS Disorders • Psychiatry • Schizophrenia

Exploring the factors and outcomes of clozapine discontinuation in India: A retrospective analysis. (PubMed, Asian J Psychiatr) - "These results align with previous studies, showing that adverse effects and inadequate response are prominent reasons for clozapine discontinuation and demonstrate the possibility of clozapine retrial in selected patients. Managing adverse effects might result in improvement, at least to a mild degree. Clozapine discontinuation can be avoided in a cohort with non-serious adverse effects, given the superiority of clozapine in resistant schizophrenia."

Journal • Retrospective data • CNS Disorders • Psychiatry • Schizophrenia

An Evaluation of the Subcutaneous Depot Release of TV-46000, A Novel Long-Acting Injectable (LAI) Formulation of Risperidone, Under Extreme Conditions in Dogs, Minipigs and Humans. (PubMed, Pharmaceutics) - "The observed similarity in findings between the animal and human studies supports the suitability of animal models for evaluation of the effect of extrinsic factors on injection sites and its translatability to clinical settings."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Alkermes plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2024 and Provides Financial Expectations for 2025 (PRNewswire) - "Royalty revenues from XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI for the fourth quarter were $36.5 million. VUMERITY manufacturing and royalty revenues for the fourth quarter were $35.0 million. FAMPYRA manufacturing and royalty revenues for the fourth quarter were $22.9 million. The company does not expect to record any FAMPYRA revenue going forward. RISPERDAL CONSTA manufacturing revenues for the fourth quarter were $14.7 million."

Commercial • Bipolar Disorder • CNS Disorders • Multiple Sclerosis • Schizophrenia

Real-World Effectiveness of Long-Acting Injectable and Oral Antipsychotic Agents in US Medicare Patients with Schizophrenia. (PubMed, Adv Ther) - "Efforts are needed to enhance identification of appropriate candidates for LAIs and increase their uptake, especially longer dosing interval LAIs, in the Medicare population."

Journal • Medicare • Real-world evidence • Reimbursement • US reimbursement • CNS Disorders • Psychiatry • Schizophrenia

Combination Therapy With Risperidone and High-Dose Melatonin Is Effective Despite Reversible Side Effects Including Breast Budding. (PubMed, Cureus) - "Risperidone and high-dose melatonin administration effectively reduced restlessness. Administration of risperidone and high-dose melatonin may cause breast budding; however, breast budding is reversible upon the discontinuation of melatonin, and we suggest that clinicians prescribe medication as needed to improve these symptoms."

Adverse events • Journal • CNS Disorders • Pain • Sleep Disorder

Pharmacokinetics and Safety of a Novel Extended-Release Microsphere Formulation of Risperidone in Patients with Schizophrenia or Schizoaffective Disorder. (PubMed, J Clin Pharmacol) - "Risperidone extended-release injectable suspension (R-ERIS; marketed as RYKINDO) is a novel immediate-release version of risperidone formulated as extended-release microspheres for biweekly intramuscular injection to treat schizophrenia in adults...Eligible patients (N = 108) 18 to 65 years old were randomized (1:1) to receive IM injections of R-ERIS 25 mg or the comparator, a biweekly risperidone long-acting injectable (BW-RLAI; marketed as RISPERDAL CONSTA) 25 mg for a total of 5 injections...R-ERIS was safe and well tolerated. Overall, R-ERIS exhibited a faster onset and offset than BW-RLAI and statistical analysis of exposure parameters demonstrated bioequivalence at steady state."

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

Use of Long-Acting Injectables for Severe Mental Illness in the Peripartum Period: A Case Report and a Scoping Review. (PubMed, Cureus) - "The pharmacokinetic profile of long-acting injectable (LAI) risperidone contrasts with that of oral risperidone, characterized by a gradual and consistent release from the depot, mitigating fluctuations between peak and trough concentrations...This case underscores the significance of individualized treatment strategies and emphasizes the potential utility of LAI antipsychotics as a viable therapeutic option for managing acute mania in pregnancy. Further research is warranted to delineate the long-term outcomes and safety profile of LAI antipsychotics in this population."

Journal • Review • Bipolar Disorder • CNS Disorders • Metabolic Disorders • Mood Disorders • Obstetrics • Psychiatry

The use of zuclopenthixol depot in an adolescent with methamphetamine induced schizophrenia (ECNP 2024) - "The patient was diagnosed with methamphetamine induced schizophrenia and oral risperidone 2 mg per day and quetiapine 25 mg per day (to regulate sleep) were started... Although not first line, typical antipsychotics are beneficial for some selected patients especially when diagnosed with severe mental disorders. The abuse of narcotic drugs and psychotropic substances such as amphetamines has shown a growing trend since 2000s and stated to become a public health problem. In this report, we presented the use of zuclopenthixol LAI in a methamphetamine induced schizophrenia case."

ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Cognitive Disorders • Mental Retardation • Mood Disorders • Psychiatry • Schizophrenia • Substance Abuse

Novel dissolution methods for drug release testing of Long-Acting injectables. (PubMed, Int J Pharm) - "These adapters were validated and assessed using the long-acting injectable (LAI) suspension drug product Depo Provera 150® as well as its Q1/Q2 equivalents...A successful Level A IVIVC was developed for Depo SubQ Provera 104® and its Q1Q2 equivalents using USP apparatus type IV with a conical adapter design. The closed adapter design for apparatus type-II was also investigated for suitability with risperidone in situ forming implants. The adapter was able to securely retain and maintain the shape of the in situ forming implants and resulted in release profiles of up to one month with good discriminatory ability and low standard error (RSD≤5%). These novel adapters hold promise of wide use for in vitro release testing of different long-acting parenteral drug products."

Journal

Physiologically-Based Pharmacokinetic Modeling and In Vitro-In Vivo Correlation of TV-46000 (Risperidone LAI): Prediction from Dog to Human. (PubMed, Pharmaceutics) - "The resulting simulated TV-46000 PK profile in humans showed that the shape of the predicted risperidone and its active metabolite 9-OH-risperidone PK profiles was different from the observed one, thus suggesting that the TV-46000 release profile was species-dependent and cannot be directly extrapolated from dog to human. In conclusion, while level A IVIVC cannot be claimed, this work combining PBPK and IVIVC modeling represents an interesting alternative approach for complex injectable formulations where classical methods are not applicable."

Journal • PK/PD data • Preclinical • CNS Disorders • Psychiatry • Schizophrenia

A Case of Adolescent Catatonia that Relapsed after Rapid Discontinuation of ECT Treatment (WFSBP 2024) - "Lorazepam was initiated but changed to clonazepam as patient’s symptoms persisted after 4 weeks of lorazepam use. Olanzapine was also added with lorazepam but discontinued after 4 weeks as his psychotic symptoms continued...He was discharged with risperidone 4mg/d, risperidone depot 25mg/2 weeks, quetiapine 1200mg/d, biperiden 6mg/d, clonazepam 4mg/d... When planning ECT treatment, starting 2-3 times a week and gradually reducing it to once a week may be effective in preventing relapse. Additional research should be done to determine the association."

Clinical • CNS Disorders • Psychiatry • Schizophrenia

Aripiprazole and CYP2D6: High Discontinuation Rate at 3 Months in Poor and Ultrarapid Metabolizers (WFSBP 2024) - "Jukic MM, Smith RL, Haslemo T, Molden E, Ingelman-Sundberg M. Effect of CYP2D6 genotype on exposure and efficacy of risperidone and aripiprazole: a retrospective, cohort study. The risk of early discontinuation from ARI was higher in extreme CYP2D6 metabolizers than in the other phenotype groups. This supports pre-emptive genotyping for CYP2D6 before aripiprazole treatment, also considering CYP2D6 strong inhibitors. 1."

CNS Disorders • Psychiatry

Personal and Social Functioning in Schizophrenia and Bipolar Affective Disorder-Type I Patients on Long-Acting Injectable Antipsychotics:A Pilot Study (APA 2024) - "Working Hypothesis: The aim of this study is to investigate if long acting injectable antipsychotics have decreased a risk of rehospitalization, improved tolerability, functionality and quality of life in schizophrenia and bipolar I patients.Study Design and This is a pilot retrospective study in which assessment of personal and social functioning was conducted by Social and Personal Performance Scale as well as with a therapeutic consultation with patients and their family members, and charts review of 10 patients with schizophrenia and bipolar I disorder on Aripiprazole Once Monthly or Paliperidone Palmitate Once Monthly or Risperidone Consta injections... based on this observation, there is a potential for a gainful employment in some bipolar patients on long acting injectable. Further higher quality studies with a larger sample size needs to be conducted in order to verify the results that were found in this pilot study."

Clinical • Bipolar Disorder • CNS Disorders • Psychiatry • Schizophrenia