Neupro (rotigotine transdermal) / Otsuka, UCB - LARVOL DELTA

Dopaminergic Therapy for Frontotemporal Dementia Patients (clinicaltrials.gov) - P2 | N=75 | Completed | Sponsor: I.R.C.C.S. Fondazione Santa Lucia | Active, not recruiting ➔ Completed

Trial completion • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Developmental Disorders • Frontotemporal Lobar Degeneration • Mental Retardation • Metabolic Disorders • Proteinopathy • Psychiatry

Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Virginia Commonwealth University | Phase classification: P2a ➔ P2

Phase classification

Dissolving microarray patches loaded with a rotigotine nanosuspension: A potential alternative to Neupro® patch. (PubMed, J Control Release) - "The in vivo pharmacokinetic studies demonstrated that RTG-NS MAPs, though smaller (2 cm2 for dissolving MAPs and 6 cm2 for Neupro®), delivered drug levels comparable to Neupro®, indicating higher efficiency per unit area. This could potentially avoid unnecessarily high plasma levels after the next dose at 24 h, highlighting the benefits of dissolving MAPs over conventional transdermal patches in PD treatment."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

Carboxymethyl cellulose-based rotigotine nanocrystals-loaded hydrogel for increased transdermal delivery with alleviated skin irritation. (PubMed, Carbohydr Polym) - "Transdermal rotigotine (RTG) therapy is prescribed to manage Parkinson's disease (Neupro® patch)...Further, NS-HG was chemically stable; >95 % of the drug was preserved up to 4 weeks under long term (25 °C/RH60%), accelerated (40 °C/RH75%), and stress (50 °C) storage conditions. Therefore, this novel cellulose derivative-based nanoformulation presents a promising approach for effective transdermal RTG delivery with improved tolerability."

Journal • CNS Disorders • Dermatology • Movement Disorders • Parkinson's Disease

A follow-up study of rotigotine patch in adolescent subjects with Restless Legs Syndrome (clinicaltrialsregister.eu) - P3 | N=138 | Sponsor: UCB Biopharma SRL

Monotherapy • New P3 trial • Movement Disorders • Restless Legs Syndrome • Sleep Disorder

A study of rotigotine patch in adolescent subjects with Restless Legs Syndrome of unknown cause (clinicaltrialsregister.eu) - P3 | N=138 | Sponsor: UCB Biopharma SRL

New P3 trial • Movement Disorders • Restless Legs Syndrome • Sleep Disorder

Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder (clinicaltrials.gov) - P2a | N=60 | Recruiting | Sponsor: Virginia Commonwealth University | Not yet recruiting ➔ Recruiting

Enrollment open

Financial impact of Parkinson’s disease on women and men (MDS Congress 2023) - "Symptom severity for the past 12 months, use of mobility devices, history of device-assisted therapy (deep brain stimulation, duopa or levodopa-carbidopa intestinal gels, apomorphine infusion, neupro patch), financial costs associated with Parkinson’s medications for the past 12 months were compared between women and men.; Majority of the cohort had medical insurance (98.9%) and identified as non-Hispanic (96%) and White (97.3%). Financial costs associated with Parkinson’s medications are similar for women and men, despite women having less income and being younger. Longer disease duration, more income, device assisted therapy use are associated with higher costs associated with Parkinson’s medication. Socioeconomic and demographic factors can contribute to the gender disparities in PD."

Clinical • CNS Disorders • Pain • Parkinson's Disease

Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder (clinicaltrials.gov) - P2a | N=60 | Not yet recruiting | Sponsor: Virginia Commonwealth University | Initiation date: Jun 2023 ➔ Sep 2023

Trial initiation date

Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder (clinicaltrials.gov) - P2a | N=60 | Not yet recruiting | Sponsor: Virginia Commonwealth University

New P2a trial

A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome (clinicaltrials.gov) - P3 | N=10 | Terminated | Sponsor: UCB Biopharma SRL | N=138 ➔ 10 | Trial completion date: Oct 2024 ➔ Sep 2022 | Enrolling by invitation ➔ Terminated | Trial primary completion date: Oct 2024 ➔ Sep 2022; Sponsor decision; Not a safety decision

Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Movement Disorders • Restless Legs Syndrome • Sleep Disorder

A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause (clinicaltrials.gov) - P3 | N=23 | Terminated | Sponsor: UCB Biopharma SRL | N=138 ➔ 23 | Trial completion date: Oct 2023 ➔ Jul 2022 | Recruiting ➔ Terminated | Trial primary completion date: Oct 2023 ➔ Jul 2022; Sponsor decision; Not a safety decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Movement Disorders • Restless Legs Syndrome • Sleep Disorder

Teva, Viatris win U.S. appeal in patent fight over Parkinson's drug (The Economic Times) - "Belgian biopharmaceutical company UCB on Wednesday lost its U.S. court appeal seeking to revive a patent covering its Parkinson's disease drug Neupro, clearin an obstacle for Teva's Actavis Laboratories UT Inc and Viatris' Mylan Technologies Inc to sell generic versions of the drug. The U.S. Court of Appeals for the Federal Circuit agreed with a Delaware federal court that UCB's patent on Neupro patches was invalid. A ruling for UCB could have delayed U.S. Food and Drug Administration approval of a Neupro generic until it expired in December 2030, the court said."

Corporate lawsuit • Patent • CNS Disorders • Parkinson's Disease

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BioCareSD Adds Six New Products to Existing Portfolio in Partnership with UCB (BioSpace) - "BioCareSD...announced a contract with UCB to add six new product offerings to its already diverse portfolio. This partnership, which will enable BioCareSD to service a wider patient population, demonstrates the organization’s continued commitment to being the industry’s most trusted healthcare partner....BRIVIACT® - partial-onset seizures in patients one month of age and older CIMZIA® - Crohn’s Disease and Rheumatoid Arthritis NAYZILAM® - intermittent, stereotypic episodes of frequent seizure activity, distinct from patient’s usual seizure pattern in patients with epilepsy 12 years of age and older NEUPRO® - Parkinson’s Disease and Restless Leg Syndrome KEPPRA® - partial-onset seizures in adults with epilepsy VIMPAT® - partial-onset seizures in patients with epilepsy 17 years of age and older."

Licensing / partnership • CNS Disorders • Crohn's disease • Epilepsy • Parkinson's Disease • Restless Legs Syndrome • Rheumatoid Arthritis

Strong first six months – UCB with continued delivery and strong resilience (UCB Press Release) - "NEUPRO® (rotigotine), the patch for Parkinson’s disease and restless legs syndrome, recorded declining net sales in the U.S. and international markets, namely Japan, and stable net sales in Europe – in a competitive market environment."

Commercial • CNS Disorders • Parkinson's Disease • Restless Legs Syndrome

Dopaminergic Therapy for Frontotemporal Dementia Patients (clinicaltrials.gov) - P2 | N=75 | Active, not recruiting | Sponsor: I.R.C.C.S. Fondazione Santa Lucia | Recruiting ➔ Active, not recruiting | Trial primary completion date: Sep 2023 ➔ Dec 2023

Enrollment closed • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Developmental Disorders • Frontotemporal Lobar Degeneration • Immunology • Mental Retardation • Metabolic Disorders • Proteinopathy • Psychiatry

2021 – Delivering on UCB’s Strategy and Commitments (UCB Press Release) - "UCB0599 - In collaboration with UCB's new partner Novartis a Phase 2a study with UCB0599 for study participants with early-stage PD started, first topline results are expected in H2 2023....NEUPRO® (rotigotine), the patch for Parkinson’s disease and restless legs syndrome, used by 385 000 patients, recorded stable net sales in a competitive market environment."

Commercial • P2 data • Trial status • CNS Disorders • Parkinson's Disease • Restless Legs Syndrome

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Heterogeneity

The Practical Effect of Neupro (clinicaltrials.gov) - P; N=3000; Recruiting; Sponsor: Peking University Third Hospital

Clinical • New trial • Real-world evidence • CNS Disorders • Movement Disorders • Parkinson's Disease

Dopaminergic Therapy for Frontotemporal Dementia Patients (clinicaltrials.gov) - P2; N=75; Recruiting; Sponsor: I.R.C.C.S. Fondazione Santa Lucia

Clinical • New P2 trial • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Developmental Disorders • Frontotemporal Lobar Degeneration • Immunology • Mental Retardation • Metabolic Disorders • Proteinopathy • Psychiatry

[VIRTUAL] GABAergic Neurons in the Dorsal Raphe Nucleus Are under the Influence of GABAergic Inputs from the Nucleus Pontis Oralis (SLEEP 2021) - "Support (if any) NS092383 Introduction Our previous study has shown that there is a direct connection between GABAergic neurons in the nucleus pontis oralis (NPO) and neurons of the dorsal raphe nucleus (DR), providing a morphological basis for the hypothesis that GABAergic inhibitory processes in NPO play an important role in the generation and maintenance of wakefulness as well as active (REM) sleep through the interaction with neurons in the DR...Our previous study has demonstrated that these GABAergic inputs are from the NPO. These data provide a morphological foundation to support our hypothesis that, during wakefulness, NPO GABAergic “Executive” neurons suppress “Second-Order” GABAergic neurons in the DR, which, in turn, activate (disinhibit) serotonergic wake-on neurons in this nucleus."

CNS Disorders

A Study to Assess Pharmacokinetic Profiles of LY03003 and Neupro (clinicaltrials.gov) - P1; N=40; Completed; Sponsor: Luye Pharma Group Ltd.; Recruiting ➔ Completed

Trial completion • CNS Disorders • Movement Disorders • Parkinson's Disease

Drugs for Parkinson's disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Depression • Movement Disorders • Parkinson's Disease • Psychiatry

Comparison chart: Drugs for Parkinson's disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease