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News on April 20, 2021 /bioon.
com" target="_blank">/ --The British pharmaceutical company GW Pharma is a global leader in the research and development of plant-derived cannabinoid therapeutic products, and is committed to discovering, developing and commercializing new therapeutic drugs from cannabis.
Recently, the company announced that the European Commission (EC) has approved a Class II change application for Epidylex (cannabidiol, cannabidiol, CBD) oral liquid formulations as an adjuvant therapy for patients ≥ 2 years of age, treatment and outcome Seizures associated with Sexual Sclerosis Syndrome (TSC).
It is worth mentioning that this is Epidyolex's third indication in Europe.
Previously, the drug has been approved for use in patients ≥ 2 years of age to assist in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS).
bioon.com" target="_blank">/ --The British pharmaceutical company GW Pharma is a global leader in the research and development of plant-derived cannabinoid therapeutic products, and is committed to discovering, developing and commercializing new therapeutic drugs from cannabis.
Recently, the company announced that the European Commission (EC) has approved a Class II change application for Epidylex (cannabidiol, cannabidiol, CBD) oral liquid formulations as an adjuvant therapy for patients ≥ 2 years of age, treatment and outcome Seizures associated with Sexual Sclerosis Syndrome (TSC).
It is worth mentioning that this is Epidyolex's third indication in Europe.
Previously, the drug has been approved for use in patients ≥ 2 years of age to assist in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS).
com" target="_blank">
In the United States, the drug (U.
S.
market name: Epidiolex) has also been approved for three indications: for patients ≥ 1 year old, as an adjuvant treatment for seizures related to LGS, DS, and TSC.
In the United States and the European Union, Epidyolex/Epidiolex has been granted orphan drug designation for the treatment of DS, LGS, and TSC-related seizures.
Each disease is a rare, serious, and childhood-onset drug-refractory type of epilepsy.
S.
market name: Epidiolex) has also been approved for three indications: for patients ≥ 1 year old, as an adjuvant treatment for seizures related to LGS, DS, and TSC.
In the United States and the European Union, Epidyolex/Epidiolex has been granted orphan drug designation for the treatment of DS, LGS, and TSC-related seizures.
Each disease is a rare, serious, and childhood-onset drug-refractory type of epilepsy.
In February of this year, Jazz Pharma announced the acquisition of GW Pharma for US$7.
2 billion, and the transaction has been unanimously approved by the boards of directors of both parties.
The acquisition is expected to be completed in the second quarter of 2021, and the combined company will become a leader in the field of neuroscience.
2 billion, and the transaction has been unanimously approved by the boards of directors of both parties.
The acquisition is expected to be completed in the second quarter of 2021, and the combined company will become a leader in the field of neuroscience.
Epidyolex/Epidiolex is the first plant-derived cannabinoid drug approved by the United States and Europe for the treatment of epilepsy.
The drug is an oral, liquid preparation of high-purity CBD extract.
CBD is a non-psychological ingredient derived from the hemp plant and has a variety of pharmacological effects on the nervous system.
A large number of studies have shown that CBD has obvious anti-epileptic and anti-convulsant activities, and has fewer side effects than existing anti-epileptic drugs.
The drug is an oral, liquid preparation of high-purity CBD extract.
CBD is a non-psychological ingredient derived from the hemp plant and has a variety of pharmacological effects on the nervous system.
A large number of studies have shown that CBD has obvious anti-epileptic and anti-convulsant activities, and has fewer side effects than existing anti-epileptic drugs.
TSC is a rare and serious bioon.
com/course_video/zhong-guo-ren-qun-ying-yang-he-yi-chuan-yin416058.
html">genetic disease that occurs during childhood.
Epilepsy is the most common neurological feature of TSC.
TSC can cause epilepsy in up to 85% of patients, and as many as 60% of patients do not respond to standard antiepileptic drugs and are drug-resistant seizures.
There is a significant need for new treatments in addressing seizures associated with TSC.
Data from a phase III clinical study showed that compared with placebo, Epidiolex significantly reduced TSC-related refractory seizures (including focal and generalized) and improved the overall condition of the patient.
Epidyolex/Epidiolex will provide an important treatment option for the TSC patient population.
bioon. com/course_video/zhong-guo-ren-qun-ying-yang-he-yi-chuan-yin416058.
html">genetic disease that occurs during childhood.
Epilepsy is the most common neurological feature of TSC.
TSC can cause epilepsy in up to 85% of patients, and as many as 60% of patients do not respond to standard antiepileptic drugs and are drug-resistant seizures.
There is a significant need for new treatments in addressing seizures associated with TSC.
Data from a phase III clinical study showed that compared with placebo, Epidiolex significantly reduced TSC-related refractory seizures (including focal and generalized) and improved the overall condition of the patient.
Epidyolex/Epidiolex will provide an important treatment option for the TSC patient population.
com/course_video/zhong-guo-ren-qun-ying-yang-he-yi-chuan-yin416058.
html">Genetic
png" target="_blank">
png" target="_blank">Tuberous Sclerosis Syndrome-TSC (Image source: childneurologyfoundation.
org)
org)
The approval of the new indication is based on the results of a randomized, double-blind, placebo-controlled Phase III clinical study.
The study enrolled 224 patients (age 1-65 years old) who were diagnosed as resistant to treatment (refractory).
These patients were randomly assigned to receive Epidiolex 25mg/kg/day (n=75), Epidiolex 50mg/kg/day (n=73), placebo (n=76), treatment for 16 weeks (4-week titration period, 12-week maintenance period).
The primary endpoint was the percentage change from baseline in the frequency of TSC-related focal and generalized seizures between Epidiolex and placebo during treatment.
Key secondary endpoints include: the proportion of patients with a reduction of ≥50% in seizures, the proportion of patients with a reduction in total seizure frequency (including focal sensation and seizures) by ≥50%, and the overall impression of changes in the overall condition of the subject/caregiver (S/CGIC).
The study enrolled 224 patients (age 1-65 years old) who were diagnosed as resistant to treatment (refractory).
These patients were randomly assigned to receive Epidiolex 25mg/kg/day (n=75), Epidiolex 50mg/kg/day (n=73), placebo (n=76), treatment for 16 weeks (4-week titration period, 12-week maintenance period).
The primary endpoint was the percentage change from baseline in the frequency of TSC-related focal and generalized seizures between Epidiolex and placebo during treatment.
Key secondary endpoints include: the proportion of patients with a reduction of ≥50% in seizures, the proportion of patients with a reduction in total seizure frequency (including focal sensation and seizures) by ≥50%, and the overall impression of changes in the overall condition of the subject/caregiver (S/CGIC).
The results showed that the study reached the primary endpoint.
Compared with the placebo group, the frequency of TSC-related seizures in the Epidiolex treatment group was significantly reduced: the Epidiolex 25mg/kg/day treatment group and the 50mg/kg/day treatment group were respectively 49% lower than the baseline.
48%, the placebo group decreased by 27% (p=0.
0009, p=0.
00118).
Compared with the placebo group, the frequency of TSC-related seizures in the Epidiolex treatment group was significantly reduced: the Epidiolex 25mg/kg/day treatment group and the 50mg/kg/day treatment group were respectively 49% lower than the baseline.
48%, the placebo group decreased by 27% (p=0.
0009, p=0.
00118).
The results for all key secondary endpoints support the impact on the primary endpoint.
Specifically: (2) Compared with the placebo group, a higher proportion of patients in the Epidiolex treatment group had a 50% or greater reduction in seizures (36% in the 25 mg/kg/day group and 36% in the 50 mg/kg/day group) 40%, 22% in the placebo group, p=0.
0692 and p=0.
0245).
(2) Compared with the placebo group, 48% of the patients in the two-dose Epidiolex treatment group experienced a greater reduction in total seizure frequency (including focal sensation and seizures), compared with 27% in the placebo group ( p=0.
0013 and p=0.
0018).
(3) According to the results of the overall impression of patients/caregivers (S/CGIC) questionnaire, the proportions of Epidiolex 25mg/kg/day group and Epidiolex 50mg/kg/day group reporting overall improvement were 69%, 62%, and comfort, respectively The dose group was 39% (p=0.
0074 and p=0.
0580).
(4) Additional analysis showed that compared with placebo patients, Epidiolex treated patients experienced a greater reduction in compound focal seizures (the proportion of patients in the 25mg/kg/day treatment group, 50mg/kg/day treatment group) Respectively 52%, 50%, the proportion of placebo group was 32%, p=0.
0076 and p=0.
0116).
Specifically: (2) Compared with the placebo group, a higher proportion of patients in the Epidiolex treatment group had a 50% or greater reduction in seizures (36% in the 25 mg/kg/day group and 36% in the 50 mg/kg/day group) 40%, 22% in the placebo group, p=0.
0692 and p=0.
0245).
(2) Compared with the placebo group, 48% of the patients in the two-dose Epidiolex treatment group experienced a greater reduction in total seizure frequency (including focal sensation and seizures), compared with 27% in the placebo group ( p=0.
0013 and p=0.
0018).
(3) According to the results of the overall impression of patients/caregivers (S/CGIC) questionnaire, the proportions of Epidiolex 25mg/kg/day group and Epidiolex 50mg/kg/day group reporting overall improvement were 69%, 62%, and comfort, respectively The dose group was 39% (p=0.
0074 and p=0.
0580).
(4) Additional analysis showed that compared with placebo patients, Epidiolex treated patients experienced a greater reduction in compound focal seizures (the proportion of patients in the 25mg/kg/day treatment group, 50mg/kg/day treatment group) Respectively 52%, 50%, the proportion of placebo group was 32%, p=0.
0076 and p=0.
0116).
The safety profile observed in this study is consistent with the results of previous studies, and no new safety risks have been discovered.
The incidence of adverse events (AE) was 93% in the 25 mg/kg/day group, 100% in the 50 mg/kg/day group, and 95% in the placebo group.
Both doses have acceptable safety, with 25 mg/kg/day adverse events less than 50 mg/kg/day.
The most common bioon.
com/course_info/series_11.
html">adverse reactions are diarrhea, decreased appetite and lethargy.
()
bioon. The incidence of adverse events (AE) was 93% in the 25 mg/kg/day group, 100% in the 50 mg/kg/day group, and 95% in the placebo group.
Both doses have acceptable safety, with 25 mg/kg/day adverse events less than 50 mg/kg/day.
The most common bioon.
com/course_info/series_11.
html">adverse reactions are diarrhea, decreased appetite and lethargy.
()
com/course_info/series_11.
html">Adverse reactions
Original source: GW Pharmaceuticals receives European Commission app roval for EPIDYOLEX (cannabidiol) for the treatment of seizures associated with tuberous sclerosis complex
app 
