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

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

Initiation Regimens for Long-Acting Injectable Antipsychotics Requiring Oral Supplementation: Impact on Subsequent Maintenance Treatment Adherence and Persistence (SIRS 2024) - "Among 1958 patients with ≥1 im risperidone microspheres q2w claim, 278 met inclusion criteria. Of those patients who met criteria, 137 (49.3%) followed the initiation regimen based on the prescribing information. Propensity score matching identified 117 matched pairs of patients."

Adherence • Clinical • CNS Disorders • Schizophrenia

Switching Patients With Schizophrenia to TV-46000, a Long-Acting Subcutaneous Antipsychotic (LASCA), From Risperidone Microspheres (R064766): An Exploration of Population Pharmacokinetic (PopPK)–Based Strategies (SIRS 2024) - "The objective of this analysis was to use PopPK modeling to characterize dosing conversions and switching strategies from R064766 (an intramuscular [im] LAI formulation of risperidone microspheres administered once every 2 weeks [q2w]; Risperdal Consta®) to TV-46000 (a LASCA formulation of risperidone administered once monthly [q1m] or once every 2 months [q2m])... R064766 displayed a delayed-release profile that started around 3 weeks post injection, hence the need for 21 days of oral supplementation during initiation. TAM concentrations were then maintained at therapeutic levels for 4–6 weeks, after which (at week 7) they began to diminish. TV-46000 has a rapid initial release that results in therapeutic plasma levels within 6–24 hours of 2024 Congress of the Schizophrenia International Research Society the first injection and eliminates the need for loading dose(s) and/or oral supplementation during initiation."

Clinical • PK/PD data • CNS Disorders • Schizophrenia

Involuntary Psychiatric Hospitalization of Minors Due to Court Orders: Effectiveness Assessing Through a Case Series (EPA 2024) - "Treatment refusal rates were 88% so in terms of treatment, 88% of the minors in this sample treated with depot form antipsychotic medications, with the most common medication being risperidone... The findings suggest that involuntary hospitalization can be effective in reducing disruptive behaviors and increasing treatment compliance in minors with conduct disorders, substance abuse disorders and a history of juvenile delinquency. These results underscore the need for comprehensive, multidisciplinary approaches that integrate psychiatric treatment, psychoeducation and social support. Given the relatively small sample size and short-term follow-up, further research is needed to determine the long-term effects of involuntary treatment and to identify factors that predict treatment response."

Clinical • Late-breaking abstract • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Behavior Disorders • CNS Disorders • Psychiatry • Substance Abuse

Use of long-acting treatments in adult social care. Experience of an Acute Inpatient Mental Health Unit. (EPA 2024) - "For this, an induction regimen was followed: fisrt, monthly paliperdione 100mg depot was administered, 4 days later, monthly paliperidone 150mg depot and 4 days later, the biannual injection. Other depot treatment alternatives would have been aripripazole or risperidone... Long-acting antipsychotics are an effective alternative for the treatment of patients with Schizophrenia, especially for those in whom we can not ensure good therapeutic adherence. In addition, the induction regimen allows treatment to be administered more quickly than that carried out in Mental Health outpatient programs, thus reducing the average hospital stay. In recent years, great advances have been made in the treatment of psychotic symptoms thanks to depot drugs, which allows for numerous effective alternatives for the treatment of these patients."

Clinical • CNS Disorders • Psychiatry • Schizophrenia

Paliperidone LAI-Induced Leukocytopenia: A Case Report (EPA 2024) - "She is currently stable taking sertindole 16 mg/day, clonazepam 2 mg/day and alprazolam 0.5 mg/day...It has been proposed that drug-induced neutropenia is often dose-dependent, which could explain why our patient exhibited tolerability to risperidone but developed cytopenia upon transitioning to depot paliperidone. While cases of agranulocytosis have been reported in association with the use of other antipsychotics these antipsychotics do not require the same monitoring as clozapine. Our case emphasizes the need for vigilant blood dyscrasia monitoring during antipsychotic therapy."

Clinical • CNS Disorders • Psychiatry • Schizophrenia

Treatment Resistant Early-Onset Schizophrenia: A Tale of Two Siblings (EPA 2024) - "Risperidone to olanzapine switch made and clinical remission observed...Clozapine and aripipirazole treatment started and she discharged in partial remission... Despite trials of multiple antipsychotic medications and adjunctive treatments, both siblings demonstrated significant treatment resistance. These sibling cases underscore the complexity and challenges in managing EOS, particularly when it presents with treatment resistance. The shared familial environment and potential genetic factors demand further investigation to elucidate the pathogenesis of EOS and optimize therapeutic approaches."

CNS Disorders • Psychiatry • Schizophrenia

Differential diagnosis in chronic psychosis: a case report (EPA 2024) - "We tried oral aripiprazole and paliperidone but retired both due to bad tolerance... It is important to explore the evolution of a psychotic disorder in order to differentiate between a schizophrenia and a delusional disorder, as the prognosis differs significantly. Using Risperidone monthly depot can be a good option for treating a psychotic disorder (Sampson et al. Cochrane Database Syst Rev 2016."

Clinical • CNS Disorders • Insomnia • Mood Disorders • Psychiatry • Schizophrenia • Sleep Disorder

A comparison of recurrence rates after discontinuation of second-generation antipsychotic long-acting injectable versus corresponding oral antipsychotic in the maintenance treatment of bipolar disorder: A systematic review. (PubMed, Psychiatry Res) - "We found five studies [one aripiprazole monohydrate once monthly (AOM) study, one oral aripiprazole (OARI) study, two 2 weeks risperidone-LAI (RIS-LAI) studies, and one oral paliperidone (OPAL) study]. Numerically lower recurrence rates at 2, 4, 6, 8, and 16 weeks were observed when RIS-LAI was discontinued when compared with discontinuation from OPAL. These results can be interpreted as a substantial delay in time to recurrence with a LAI antipsychotics formulation compared to the oral equivalent when medication is discontinued in patients with mania who had been stabilized on LAI antipsychotics or corresponding oral antipsychotics."

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

Population Pharmacokinetic Analysis to Support and Facilitate Switching from Risperidone Formulations to Rykindo in Patients with Schizophrenia. (PubMed, Neurol Ther) - P1 | "This established approach provides guidance to physicians to initiate Rykindo therapy in adult patients with schizophrenia."

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

Prevention of physical risks in a patient with resistant schizophrenia with somatic delusions (ECNP 2023) - "Clozapine constitutes the treatment of choice in patients with schizophrenia with persisting symptoms despite antipsychotics at adequate dose and treatment duration...Within these strategies used in resistance to delirium, closer communication is necessary through psychiatric medical reports and updated reviews of medical records to alert the entire health system that corresponds to it. Given the complexity of transmitting said information, especially in outpatients, it remains to analyze the ways to formalize or systematize this articulation in a fluid way to ensure greater integrity of the treatment."

Clinical • CNS Disorders • Psychiatry • Schizophrenia