Overview
Rotigotine (Neupro) is a non-ergoline dopamine agonist indicated for the treatment of Parkinson's disease (PD) and restless legs syndrome (RLS) in Europe and the United States. It is formulated as a once-daily transdermal patch which provides a slow and constant supply of the drug over the course of 24 hours. Like other dopamine agonists, rotigotine has been shown to possess antidepressant effects and may be useful in the treatment of depression as well. Rotigotine was developed by Aderis Pharmaceuticals. In 1998 Aderis licensed worldwide development and commercialization rights to Schwarz Pharma of Germany. It was approved by the European Medicines Agency in 2006 and by the FDA in 2007. However, all Neupro patches in the United States and some of Europe were recalled in 2008 due to delivery mechanism issues. Rotigotine has been authorized as a treatment for RLS since August 2008.
Indication
For use/treatment in neurologic disorders and parkinson's disease as well as moderate-to-severe primary Restless Legs Syndrome.
Associated Conditions
- Moderate restless legs syndrome (RLS)
- Parkinson's Disease (PD)
- Severe restless legs syndrome (RLS)
Research Report
A Comprehensive Monograph on Rotigotine (Neupro®): Pharmacology, Clinical Efficacy, and Therapeutic Profile
Introduction and Overview
Executive Summary
Rotigotine is a second-generation, non-ergoline dopamine agonist that occupies a distinct position in the therapeutic armamentarium for specific neurological disorders.[1] Marketed globally under the brand name Neupro®, its defining characteristic is its formulation as a once-daily transdermal therapeutic system (TTS), or "patch".[3] This delivery system is designed to provide continuous, non-fluctuating plasma concentrations of the drug over a 24-hour period.[1] The primary approved indications for Rotigotine are the treatment of the signs and symptoms of idiopathic Parkinson's Disease (PD) and the symptomatic management of moderate-to-severe primary Restless Legs Syndrome (RLS).[7] As a small molecule drug, Rotigotine acts by directly stimulating dopamine receptors in the brain, thereby substituting for the depleted endogenous neurotransmitter in pathological states.[9] Its unique delivery method and broad receptor binding profile differentiate it from other therapies, presenting both distinct advantages and a specific set of clinical and manufacturing challenges that have shaped its development and therapeutic application.
The Concept of Continuous Dopaminergic Stimulation (CDS)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/11/22 | Phase 3 | Recruiting | I.R.C.C.S. Fondazione Santa Lucia | ||
2024/02/07 | Phase 2 | Completed | SocraTec R&D GmbH | ||
2023/06/02 | Phase 2 | Recruiting | |||
2021/07/12 | N/A | UNKNOWN | |||
2021/06/24 | Phase 2 | Completed | I.R.C.C.S. Fondazione Santa Lucia | ||
2020/11/16 | Phase 1 | Completed | |||
2020/11/16 | Phase 1 | Completed | |||
2020/11/13 | Phase 1 | Completed | |||
2019/12/03 | Phase 1 | Terminated | |||
2019/06/20 | Phase 3 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
UCB, Inc. | 50474-805 | TRANSDERMAL | 6 mg in 24 h | 7/21/2021 | |
UCB, Inc. | 50474-804 | TRANSDERMAL | 4 mg in 24 h | 7/21/2021 | |
UCB, Inc. | 50474-803 | TRANSDERMAL | 3 mg in 24 h | 7/21/2021 | |
UCB, Inc. | 50474-802 | TRANSDERMAL | 2 mg in 24 h | 7/21/2021 | |
UCB, Inc. | 50474-801 | TRANSDERMAL | 1 mg in 24 h | 7/21/2021 | |
UCB, Inc. | 50474-806 | TRANSDERMAL | 8 mg in 24 h | 7/21/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 2/15/2006 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
NEUPRO rotigotine 1 mg/24 hr transdermal patch sachet | 163987 | Medicine | A | 10/19/2010 | |
NEUPRO rotigotine 6 mg/24 hr transdermal patch sachet | 131382 | Medicine | A | 11/22/2007 | |
NEUPRO rotigotine 3 mg/24 hr transdermal patch sachet | 163988 | Medicine | A | 10/19/2010 | |
NEUPRO rotigotine 4 mg/24 hr transdermal patch sachet | 131381 | Medicine | A | 11/22/2007 | |
NEUPRO rotigotine 8 mg/24 hr transdermal patch sachet | 131383 | Medicine | A | 11/22/2007 | |
NEUPRO rotigotine 2 mg/24 hr transdermal patch sachet | 131370 | Medicine | A | 11/22/2007 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
NEUPRO | UCB Canada Inc | 02403897 | Patch - Transdermal | 1 MG / 24 HOUR | 12/19/2013 |
NEUPRO | UCB Canada Inc | 02403900 | Patch - Transdermal | 2 MG / 24 HOUR | 6/27/2013 |
NEUPRO | UCB Canada Inc | 02403919 | Patch - Transdermal | 3 MG / 24 HOUR | 12/19/2013 |
NEUPRO | UCB Canada Inc | 02403935 | Patch - Transdermal | 6 MG / 24 HOUR | 6/27/2013 |
NEUPRO | UCB Canada Inc | 02403927 | Patch - Transdermal | 4 MG / 24 HOUR | 6/27/2013 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
ROTIGOTINA LUYE 2 MG/24 H PARCHES TRANSDERMICOS EFG | 89419 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
DARIANTE 4 MG/24 HORAS PARCHES TRANSDÉRMICOS EFG | Exeltis Healthcare S.L. | 89092 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica | Commercialized |
NEUPRO 8 MG/24 H PARCHE TRANSDERMICO | 05331011 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
ROTIGOTINA LUYE 4 MG/24 H PARCHES TRANSDERMICOS EFG | 89421 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
NEUPRO 1 MG/24 H PARCHE TRANSDERMICO | 05331040 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
NEUPRO 2, 4, 6, 8 MG/24 H PARCHE TRANSDERMICO | 05331013 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
DARIANTE 2 MG/24 HORAS PARCHES TRANSDÉRMICOS EFG | Exeltis Healthcare S.L. | 89090 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica | Commercialized |
DARIANTE 8 MG/24 HORAS PARCHES TRANSDÉRMICOS EFG | Exeltis Healthcare S.L. | 89094 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica | Commercialized |
NEUPRO 3 MG/24 H PARCHE TRANSDERMICO | 05331049 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
ROTIGOTINA LUYE 3 MG/24 H PARCHES TRANSDERMICOS EFG | 89420 | PARCHE TRANSDÉRMICO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
Help Us Improve
Your feedback helps us provide better drug information and insights.