paliperidone extended release / Generic mfg. - LARVOL DELTA

Efficacy and Safety of Paliperidone in Schizophrenia - Bangladesh Study (clinicaltrials.gov) - P4 | N=505 | Not yet recruiting | Sponsor: Sher-E-Bangla Medical College

New P4 trial • CNS Disorders • Psychiatry • Schizophrenia

A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication (clinicaltrials.gov) - P2 | N=233 | Completed | Sponsor: Astellas Pharma Global Development, Inc. | Phase classification: P2a ➔ P2

Phase classification • CNS Disorders • Cognitive Disorders • Psychiatry • Schizophrenia

Extension and Further Replication of the Reliability, Criterion Validity, and Treatment Sensitivity of the PANSS10 and PANSS20 for Pediatric Trials. (PubMed, J Child Adolesc Psychopharmacol) - " We examined patient-level data from a randomized pediatric schizophrenia trial comparing paliperidone ER to aripiprazole. The optimized PANSS forms continue to show impressive reliability, validity, and calibration compared with the 30-item PANSS. Researchers should consider replacing the 30-item PANSS with the PANSS10 as a clinical outcome and screening measure due to its length and psychometric performance."

Journal • CNS Disorders • Pediatrics • Psychiatry • Schizophrenia

In brief: Erzofri - another once-monthly paliperidone formulation. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Psychiatry • Schizophrenia

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies (clinicaltrials.gov) - P=N/A | N=1037352 | Terminated | Sponsor: University of New Mexico | Completed ➔ Terminated; Per PI, this study is not a clinical trial and was inadvertently entered in the system

HEOR • Trial termination • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry

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

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

"Truman syndrome" induced by online education: A case report in adolescent-Onset psychosis. (PubMed, Clin Child Psychol Psychiatry) - "A significant response was observed after paliperidone (extended release) treatment...Further studies are required to elucidate whether Truman syndrome and social anxiety are different aspects of a similar spectrum. With increasing digitalization, the direction of psychiatric diseases, including EOS, and measures that can be taken for adolescent mental health in crisis, such as pandemics, should be discussed in future research."

Journal • CNS Disorders • Mental Retardation • Mood Disorders • Psychiatry • Schizophrenia

Price, Spending, & Utilization of Oral Second-Generation Antipsychotics & the Impact of Generic Entry on Market Shares: Trend Analysis of Medicaid Database from 1991 to 2022 (ISPOR-EU 2023) - "Brand Risperdal had the highest reimbursement amount which was 29% of the total expenditure while generic Asenapine had the lowest, the trend showed gradual increase in reimbursement until 2005 following fluctuations which was projected to be continued until 2025.The average price per prescription was $298. Brand Invega had the highest average price per prescription of $2940 while generic quetiapine had the lowest with $42.the price rate continued to increase over the year for brands unlike generics... The spending on SGAPs increased tremendously over the past 30 years as more brands and generics were introduced to the market. Generic SGAPs had an impact on controlling the cost burden and there was a shift toward prescribing more generic than brand."

Medicaid • Reimbursement • US reimbursement • CNS Disorders

Fabrication, optimization and characterization of an osmotic push-pull drug delivery system for paliperidone. (PubMed, J Taibah Univ Med Sci) - "Further tablet formulation resulted in an F2 value of 75.67, indicating a dissolution profile similar to that of Invega®. Bi-layer tablets of paliperidone overcoming the drawbacks of the marketed formulation were successfully prepared, and offer advantages such as a simpler preparation process, cost effectiveness and faster preparation of the tablet core."

Journal

Cheminformatics Strategies Unlock Marburg Virus VP35 Inhibitors from Natural Compound Library. (PubMed, Viruses) - "Based on binding energies, only six compounds (Estradiol benzoate, INVEGA (paliperidone), Isosilybin, Protopanaxadiol, Permethrin, and Bufalin) were selected for subsequent investigations, focusing on interaction analysis...The study proposes that these natural compounds could serve as a therapeutic option for preventing Marburg virus infection. However, experimental validation is required to further corroborate these findings."

Journal • Ebola Virus Disease • Infectious Disease

"Anyway a less amount of the invega as you get older @JNJNews ..." (@HappyDreams101)

The Spell Has Been Broken: 5 Year Long Paranoid Delusions Disappear After Curing UTI (APA 2023) - "She began Risperidone 0.5 mg po BID and Mirtazapine 7.5 mg po QHS...After her Risperidone was increased to 3 mg BID, she agreed to take Levofloxacin and appeared more lucid, pleasant, and no longer delusional. She was started on LAI Invega and discharged...G may have improved due to her antipsychotics, UTI treatment or both. Here we discuss the challenges of determining the underlying etiology for chronic psychosis in geriatric patients."

Alzheimer's Disease • CNS Disorders • Dementia • Depression • Geriatric Disorders • Grave’s Disease • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Mental Retardation • Mood Disorders • Psychiatry

Leveraging Physiologically Based Modelling to Provide Insights on the Absorption of Paliperidone Extended-Release Formulation under Fed and Fasting Conditions. (PubMed, Pharmaceutics) - "After a high-fat/high-calorie meal, absorption is increased through the jejunum, ileum, and colon due to either increased solubilization or the better efficiency of the OROS technology. PBAM-guided approaches can improve the understanding of branded drugs and thereby aid in guiding the development of generic formulations or formulation alternatives."

Journal • CNS Disorders • Gastrointestinal Disorder • Psychiatry • Schizophrenia

Convolution-based approach for modeling the paliperidone extended release and Long-Acting Injectable (LAI) PK of once-, and three-monthly products administration and for optimizing the development of new LAI products. (PubMed, J Pharmacokinet Pharmacodyn) - "However, the convolution-based approach showed several appealing features that justify the choice of this modeling as a preferred tool for modeling Long Acting Injectable (LAI) products and for deploying an effective model-informed drug development process. In particular, the convolution-based modeling can (a) facilitate the development of in vitro/in vivo correlation, (b) be used to identify formulations with optimal in vivo release properties, and (c) be used for optimizing the clinical benefit of a treatment by supporting the implementation of integrated models connecting in vitro and in vivo drug release, in vivo drug release to PK, and PK to PD and biomarker endpoints. A case study was presented to illustrate the benefits and the flexibility of the convolution-based modeling outcomes. The model was used to evaluate the in vivo drug release properties associated with a hypothetical once-a-year administration of a LAI product with the assumption that the..."

Journal

Schizophrenia and lung cancer – about a case (ECNP 2022) - "Currently in treatment with quarterly extended-release paliperidone, with good tolerance and response...Genetics and its study is complex and greater efforts are needed to continue studying aspects that may be related to both pathologies, especially the role of nicotinic receptors. The involvement of these receptors may be interesting in the future for the treatment and, perhaps, the prevention of cancer in these patients. To conclude, highlight the role of genetics in schizophrenia and the need to broaden and deepen this path that also opens up a hopeful future."

Clinical • Ataxia • CNS Disorders • Psychiatry • Schizophrenia • CHRNA5

Paliperidone Extended Release Versus Olanzapine in Treatment-Resistant Schizophrenia: A Randomized, Double-Blind, Multicenter Study. (PubMed, J Clin Psychopharmacol) - "Paliperidone ER could be a safe alternative for treatment-resistant schizophrenia."

Clinical • Journal • CNS Disorders • Psychiatry • Schizophrenia

"Why did your home @oconeelaw county not put in place #redflaglaw at anytime? After being warned? #EndGunViolence #MentalHealthMatters #Invega @JNJNews @staceyabrams @RepLucyMcBath" (@theoklahomapost)

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies (clinicaltrials.gov) - P=N/A; N=1037352; Completed; Sponsor: University of New Mexico; Enrolling by invitation ➔ Completed

HEOR • Trial completion • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry

Dose Adjustment Model of Paliperidone in Patients With Acute Schizophrenia: A post hoc Analysis of an Open-Label, Single-Arm Multicenter Study. (PubMed, Front Psychiatry) - "This was a post hoc study of an 8-week, open-label, single-arm multicenter trial which evaluated the efficacy, safety, and tolerability of flexible doses of paliperidone ER (3-12 mg/day) in patients with acutely exacerbated schizophrenia...The multivariable logistic regression analysis showed that lower age at onset, higher baseline PANSS positive subscale score, and lower baseline Personal and Social Performance Scale (PSP) score were significant predictors of increased dose in responders. Patients with young-onset age, severe baseline symptoms, and poor function are more likely to benefit from high dosage."

Clinical • Journal • Retrospective data • CNS Disorders • Psychiatry • Schizophrenia

"J&J? The company was found guilty of off-label marketing of prescription drugs, including anti-psychotic drugs Risperdal and Invega and heart failure drug Natrecor." (@Dmdufy)

Cardiovascular • CNS Disorders • Congestive Heart Failure • Heart Failure

"@pfizerbelgie @sanofi In Dutch. @Apothekers @ZorgnetIcuro @uzgent @UZBrussel @UZAnieuws @bondmoysonovl @CMziekenfonds @ACLVB @ACOD_ABVV @ACV_Vakbond @VBOFEB @UNIZOvzw @alexanderdecroo @PieterVBO @HLN Het stopt niet zolang ik Invega krijg en niet genezen ben van rokerslong..." (@KurtFBracke)

Assessment of the Minimum Clinically Important Difference in Symptoms and Functions of Patients With Acute Schizophrenia: A Post hoc Analysis of an Open-Label, Single-Arm Multicenter Study. (PubMed, Front Psychiatry) - "The original study was an 8-week, open-label, single-arm, multicenter study of flexible doses of paliperidone-extended release (pali-ER) in Chinese patients with acutely exacerbated schizophrenia...The threshold value of MCID for schizophrenia patients was determined by choice of the assessment method to an extent. In addition, the CGI-S score appeared to be the most valid and responsive measure of effectiveness for the acute phase of schizophrenia when take the treatment satisfaction of patients as anchor."

Clinical • Journal • Retrospective data • CNS Disorders • Psychiatry • Schizophrenia

ANI Pharmaceuticals Reports First Quarter 2021 Results (Businesswire) - "Net revenues for generic pharmaceutical products were $33.0 million during the three months ended March 31, 2021, a decrease of 12.0% compared to $37.5 million for the same period in 2020....From a product perspective, the net decrease was driven by declines in sales of Ezetimibe Simvastatin, Methazolamide, Miglustat, and Diphenoxylate, somewhat tempered by increased revenues from sales of Paliperidone ER and Erythromycin Ethylsuccinate ('EES')."

Commercial • CNS Disorders • Schizophrenia

[VIRTUAL] Genesis of Mental Disorders—Could It Be Cavum Septum Pellucidum et Vergae: A Case Report of CSP With Catatonic Schizophrenia (APA 2021) - "He had a flat affect, dysphoric mood, and poor oral intake and was trialed on citalopram and mirtazapine...He showed minimal response to olanzapine, methylphenidate, and high-dose lorazepam throughout the hospital stay...After a total of 12 sessions of ECT, he was discharged, psychiatrically stable, on Invega susstena 156 mg IMmonthly for psychosis, Zoloft 50 mg daily for depression, Ativan 0.5mg twice daily for catatonia prophylaxis and outpatient follow up... Septum pellucidum is a brain midline structure which fuse in first 3 to 6 months of life. Abnormally the failure of the fusion leads to occurrence of Cavum Septum Pellucidum. Many studies have suggested that CSP pay a role in genesis of mental disorders and some correlations with symptoms of schizophrenia.(1)."

Clinical • CNS Disorders • Depression • Mental Retardation • Psychiatry • Schizophrenia • MRI

[VIRTUAL] Successful Clozapine Treatment of Vocal Tics in a Schizophrenic Patient (APA 2021) - "However, antipsychotic agents such as Quetiapine, Aripiprazole and Olanzapine have been documented in research findings to induce tic-like symptoms...The patient was started on Risperidone oral treatment and subsequently Invega Sustena...He was symptom-free, well-functioning, and ready for discharge to the community with this treatment regimen. We suggest that Clozapine augmentation therapy as a possible treatment of a persistent vocal tics, other specified tic disorder, in schizophrenic patients who are refractory to atypical antipsychotic such as Risperidone."

Clinical • CNS Disorders • Mental Retardation • Movement Disorders • Psychiatry • Schizophrenia • Tic Disorders • Tourette Syndrome