Overview
Apomorphine is a non-ergoline dopamine D2 agonist indicated to treat hypomobility associated with Parkinson's. It was first synthesized in 1845 and first used in Parkinson's disease in 1884. Apomorphine has also been investigated as an emetic, a sedative, a treatment for alcoholism, and a treatment of other movement disorders. Apomorphine was granted FDA approval on 20 April 2004.
Indication
Apomorphine is indicated to treat acute, intermittent treatment of hypomobility, off episodes associated with advanced Parkinson's disease.
Associated Conditions
- Mobility decreased
Research Report
Apomorphine (DB00714): A Comprehensive Monograph on its Pharmacology, Clinical Utility, and Safety Profile
Executive Summary
Apomorphine is a potent, non-ergoline, non-selective dopamine agonist that occupies a specialized niche in the management of advanced Parkinson's disease (PD). Its primary, well-established clinical role is the acute, intermittent treatment of hypomobility, or "off" episodes, which are debilitating motor fluctuations that occur despite optimized oral therapy.[1] The name "Apomorphine" is a historical artifact derived from its synthesis from morphine; however, it is crucial to recognize that the molecule possesses no opioid receptor activity and is devoid of narcotic properties, a point of potential clinical confusion that requires clarification.[3]
The clinical utility of apomorphine is defined by a challenging pharmacokinetic profile, characterized by poor oral bioavailability and a very short elimination half-life.[3] These limitations have been the primary drivers of pharmaceutical innovation, leading to the development of non-oral formulations designed to bypass first-pass metabolism and provide clinically meaningful drug exposure. These include a subcutaneous injection (Apokyn) for rapid rescue, a sublingual film (Kynmobi) as a non-invasive alternative, and, most recently, a continuous subcutaneous infusion device (Onapgo) for stable, long-term motor control.[5]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2023/08/07 | Phase 2 | Terminated | |||
2022/09/06 | Phase 4 | Not yet recruiting | William Ondo, MD | ||
2022/01/28 | Phase 2 | Recruiting | |||
2021/07/12 | Not Applicable | Recruiting | |||
2021/05/14 | Phase 4 | Completed | Rennes University Hospital | ||
2021/05/10 | Phase 2 | UNKNOWN | |||
2021/03/08 | N/A | Completed | |||
2018/10/03 | Not Applicable | Completed | Rennes University Hospital | ||
2018/08/09 | Phase 2 | UNKNOWN | |||
2018/01/05 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
MDD US Operations, LLC | 27505-004 | SUBCUTANEOUS | 30 mg in 3 mL | 12/20/2023 | |
MDD US Operations, LLC, a subsidiary of Supernus Pharmaceuticals, Inc | 27505-006 | SUBCUTANEOUS | 4.9 mg in 1 mL | 7/7/2025 | |
TruPharma, LLC | 52817-720 | SUBCUTANEOUS | 30 mg in 3 mL | 2/24/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
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 |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
MOVAPO | paladin pharma inc. | 02459132 | Solution - Subcutaneous | 10 MG / ML | 9/7/2017 |
KYNMOBI | sunovion pharmaceuticals canada inc | 02500299 | Film, Soluble - Sublingual | 25 MG / FILM | 11/17/2020 |
KYNMOBI | sunovion pharmaceuticals canada inc | 02500280 | Film, Soluble - Sublingual | 20 MG / FILM | 11/17/2020 |
KYNMOBI | sunovion pharmaceuticals canada inc | 02500302 | Film, Soluble - Sublingual | 30 MG / FILM | 11/17/2020 |
KYNMOBI | sunovion pharmaceuticals canada inc | 02500264 | Film, Soluble - Sublingual | 10 MG / FILM | 11/17/2020 |
HOMEOPATHIC REMEDY THC NO. 48 DPS | total health centre | 02057093 | Drops - Oral | 30 C / ML | 12/31/1994 |
MOVAPO | paladin pharma inc. | 02459140 | Solution - Subcutaneous | 10 MG / ML | N/A |
KYNMOBI | sunovion pharmaceuticals canada inc | 02500272 | Film, Soluble - Sublingual | 15 MG / FILM | 11/17/2020 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
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. |
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