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▎Editor of WuXi AppTec's content team On October 28, 2021, AbbVie announced that ABBV-951 (foslevodopa/foscarbidopa), a treatment for Parkinson's disease under investigation, has reached the primary endpoint in a pivotal phase 3 clinical trial
.
The test results showed that compared with oral levodopa/carbidopa (levodopa/carbidopa), subcutaneous infusion of ABBV-951 for 24 hours a day significantly improved the fluctuation of motor symptoms in patients with advanced Parkinson's disease
.
These results will be a key part of submitting applications to global regulators
.
Parkinson's disease is a progressive neurodegenerative disease caused by the gradual loss of brain cells that produce the neurotransmitter dopamine
.
The decline in dopamine in the brain leads to a wide range of motor and non-motor symptoms
.
Since the 1970s, the main treatment for patients has been levodopa
.
However, over time, levodopa may cause involuntary, uncontrolled movements called dyskinesia
.
In advanced patients, oral levodopa faces many challenges.
For example, the patient's gastrointestinal function declines, which prevents the drug from entering the body in time, and the oral drug cannot maintain the drug concentration in the patient's body at a stable level, which also causes the patient to exercise Increasing obstacles
.
▲Many patients cannot effectively control the symptoms of Parkinson's disease using oral therapy (picture source: AbbVie's official website) ABBV-951 is a prodrug of levodopa and carbidopa
.
They have high water solubility and can be administered by continuous subcutaneous infusion through a pump connected to the skin, thereby stably maintaining the concentration of the drug in the body
.
Image source: AbbVie's official website This randomized, double-blind, active-controlled Phase 3 clinical trial enrolled approximately 130 advanced adult patients
.
The primary end point is the "Good On" time, which is defined as the "On" time without dyskinesia + the "On" time with non-troublesome dyskinesia
.
The test results showed that at the 12th week, the "Good On" time of the ABBV-951 group increased by 2.
72 hours, while the oral drug group increased by 0.
97 hours (p=0.
0083)
.
In addition, it was observed that the ABBV-951 group improved the "Good On" time of patients in the first week and continued for the entire 12-week treatment cycle
.
In addition, the test also observed that the average bad "Off" time of the ABBV-951 group was improved compared to the baseline
.
After 12 weeks of treatment, the "Off" time of the ABBV-951 group was reduced by 2.
75 hours, and the oral medication group was reduced by 0.
96 hours (p=0.
0054)
.
In terms of safety, most adverse events (AEs) in the ABBV-951 group were mild to moderate, with a serious AE rate of 8%, and a serious AE rate of 6% in the oral drug group
.
Adverse events caused 21.
6% of patients in the ABBV-951 group and 1.
5% of patients in the oral drug group to discontinue treatment
.
The complete results of Phase 3 clinical trials will be presented at future medical conferences and submitted to peer-reviewed journals for publication
.
"Parkinson's disease is a progressive, irreversible neurological disease with debilitating symptoms that can make daily life challenging
.
"AbbVie Vice Chairman and President Dr.
Michael Severino said, "We are committed to meeting the continuing needs of patients and are encouraged by these results.
These data show that ABBV-951 may become a potential alternative treatment option for patients with advanced Parkinson's disease
.
"Reference: [1] AbbVie Announces ABBV-951 (Foslevodopa/Foscarbidopa) Showed Improvement in Controlling Motor Fluctuations Compared to Oral Levodopa/Carbidopa Medication in Pivotal Phase 3 Trial in Patients with Advanced Parkinson's Disease.
Retrieved October 28, 2021, from https ://news.
abbvie.
com/news/press-releases/abbvie-announces-abbv-951-foslevodopafoscarbidopa-showed-improvement-in-controlling-motor-fluctuations-compared-to-oral-levodopacarbidopa-medication-in-pivotal -phase-3-trial-in-patients-with-advanced-parkinsons-disease.
htm Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for information exchange only, and the views in the article do not represent medicine Ming AppTec's position does not mean that WuXi AppTec supports or opposes the views
in the
article .
This article is not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital
.
.
The test results showed that compared with oral levodopa/carbidopa (levodopa/carbidopa), subcutaneous infusion of ABBV-951 for 24 hours a day significantly improved the fluctuation of motor symptoms in patients with advanced Parkinson's disease
.
These results will be a key part of submitting applications to global regulators
.
Parkinson's disease is a progressive neurodegenerative disease caused by the gradual loss of brain cells that produce the neurotransmitter dopamine
.
The decline in dopamine in the brain leads to a wide range of motor and non-motor symptoms
.
Since the 1970s, the main treatment for patients has been levodopa
.
However, over time, levodopa may cause involuntary, uncontrolled movements called dyskinesia
.
In advanced patients, oral levodopa faces many challenges.
For example, the patient's gastrointestinal function declines, which prevents the drug from entering the body in time, and the oral drug cannot maintain the drug concentration in the patient's body at a stable level, which also causes the patient to exercise Increasing obstacles
.
▲Many patients cannot effectively control the symptoms of Parkinson's disease using oral therapy (picture source: AbbVie's official website) ABBV-951 is a prodrug of levodopa and carbidopa
.
They have high water solubility and can be administered by continuous subcutaneous infusion through a pump connected to the skin, thereby stably maintaining the concentration of the drug in the body
.
Image source: AbbVie's official website This randomized, double-blind, active-controlled Phase 3 clinical trial enrolled approximately 130 advanced adult patients
.
The primary end point is the "Good On" time, which is defined as the "On" time without dyskinesia + the "On" time with non-troublesome dyskinesia
.
The test results showed that at the 12th week, the "Good On" time of the ABBV-951 group increased by 2.
72 hours, while the oral drug group increased by 0.
97 hours (p=0.
0083)
.
In addition, it was observed that the ABBV-951 group improved the "Good On" time of patients in the first week and continued for the entire 12-week treatment cycle
.
In addition, the test also observed that the average bad "Off" time of the ABBV-951 group was improved compared to the baseline
.
After 12 weeks of treatment, the "Off" time of the ABBV-951 group was reduced by 2.
75 hours, and the oral medication group was reduced by 0.
96 hours (p=0.
0054)
.
In terms of safety, most adverse events (AEs) in the ABBV-951 group were mild to moderate, with a serious AE rate of 8%, and a serious AE rate of 6% in the oral drug group
.
Adverse events caused 21.
6% of patients in the ABBV-951 group and 1.
5% of patients in the oral drug group to discontinue treatment
.
The complete results of Phase 3 clinical trials will be presented at future medical conferences and submitted to peer-reviewed journals for publication
.
"Parkinson's disease is a progressive, irreversible neurological disease with debilitating symptoms that can make daily life challenging
.
"AbbVie Vice Chairman and President Dr.
Michael Severino said, "We are committed to meeting the continuing needs of patients and are encouraged by these results.
These data show that ABBV-951 may become a potential alternative treatment option for patients with advanced Parkinson's disease
.
"Reference: [1] AbbVie Announces ABBV-951 (Foslevodopa/Foscarbidopa) Showed Improvement in Controlling Motor Fluctuations Compared to Oral Levodopa/Carbidopa Medication in Pivotal Phase 3 Trial in Patients with Advanced Parkinson's Disease.
Retrieved October 28, 2021, from https ://news.
abbvie.
com/news/press-releases/abbvie-announces-abbv-951-foslevodopafoscarbidopa-showed-improvement-in-controlling-motor-fluctuations-compared-to-oral-levodopacarbidopa-medication-in-pivotal -phase-3-trial-in-patients-with-advanced-parkinsons-disease.
htm Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for information exchange only, and the views in the article do not represent medicine Ming AppTec's position does not mean that WuXi AppTec supports or opposes the views
in the
article .
This article is not a treatment plan recommendation
.
If you need treatment plan guidance, please go to a regular hospital
.
