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Epilepsy (Image source: biospace.
com)
com)
News from April 07, 2021 // --Angelini Pharmaceuticals, a subsidiary of the Italian healthcare company Angelini Group, recently announced that the European Commission (EC) has approved Ontozry (cenobamate) for the treatment of at least 2 anti-epileptic drugs (AED), but the condition has not been adequate.
Adult patients with controlled epilepsy, adjuvant treatment of focal seizures (with or without secondary generalized seizures) epilepsy.
Adult patients with controlled epilepsy, adjuvant treatment of focal seizures (with or without secondary generalized seizures) epilepsy.
It is estimated that there are 6 million patients with epilepsy in Europe, and about 40% of adult patients with epilepsy are still under control of epilepsy after receiving two anti-epileptic drugs (AED).
In 2 adequate and well-controlled clinical studies, Ontozry significantly reduced the frequency of focal seizures compared with placebo, and up to 20% of patients achieved zero seizures during the maintenance period.
In 2 adequate and well-controlled clinical studies, Ontozry significantly reduced the frequency of focal seizures compared with placebo, and up to 20% of patients achieved zero seizures during the maintenance period.
In the United States, cenobamate has been approved for marketing in November 2019, under the brand name Xcopri, for the adjuvant treatment of partial-onset epilepsy in adults.
Xcopri was discovered and developed by SK Biopharmaceuticals and its US subsidiary SK Life Sciences.
Earlier in 2019, SK Biopharmaceuticals signed an exclusive license agreement with Arvelle Therapeutics GmbH to develop and commercialize the drug in Europe.
Xcopri was discovered and developed by SK Biopharmaceuticals and its US subsidiary SK Life Sciences.
Earlier in 2019, SK Biopharmaceuticals signed an exclusive license agreement with Arvelle Therapeutics GmbH to develop and commercialize the drug in Europe.
In January 2021, Angelini Pharmaceuticals announced an acquisition agreement with Arvelle Therapeutics.
Therefore, Arvelle will have an exclusive license to commercialize cenobamate in the European Union and other countries in the European Economic Area.
Angelini has planned to bring Ontozry (cenobamate) to the market in the second quarter of 2021.
Therefore, Arvelle will have an exclusive license to commercialize cenobamate in the European Union and other countries in the European Economic Area.
Angelini has planned to bring Ontozry (cenobamate) to the market in the second quarter of 2021.
Emilio Perucca, former president of the International Anti-Epilepsy Federation and professor of clinical pharmacology at the University of Pavia, Italy, said: "The anti-epileptic drugs launched in the past three decades have improved our ability to choose treatment options based on the individual needs of patients, but they are difficult to treat.
Epileptic seizures have little effect on the outcome of epileptic seizures.
Cenobamate is different from these drugs because its use has led to an unprecedented zero seizure rate in these patients.
This is very important because only by avoiding seizures can patients return to normal and full Production and life.
"
Epileptic seizures have little effect on the outcome of epileptic seizures.
Cenobamate is different from these drugs because its use has led to an unprecedented zero seizure rate in these patients.
This is very important because only by avoiding seizures can patients return to normal and full Production and life.
"
Emilio Perucca, former president of the International Anti-Epilepsy Federation and professor of clinical pharmacology at the University of Pavia, Italy, said: "The anti-epileptic drugs launched in the past three decades have improved our ability to choose treatment options based on the individual needs of patients, but they are difficult to treat.
Epileptic seizures have little effect on the outcome of epileptic seizures.
Cenobamate is different from these drugs because its use has led to an unprecedented zero seizure rate in these patients.
This is very important because only by avoiding seizures can patients return to normal and full Production and life.
"
Drugs have improved our ability to choose treatment options based on the individual needs of patients, but have little effect on the outcome of epileptic seizures in patients with refractory epilepsy. Epileptic seizures have little effect on the outcome of epileptic seizures.
Cenobamate is different from these drugs because its use has led to an unprecedented zero seizure rate in these patients.
This is very important because only by avoiding seizures can patients return to normal and full Production and life.
"
Cenobamate is different from these drugs because its use has led to an unprecedented zero seizure rate in these patients.
This is very important because only by avoiding epileptic seizures can patients return to normal and full production and life.
"
In the European Union, Ontozry's regulatory approval is based on 3 clinical trials involving more than 1,900 patients .
The main trial (Study 017) has been published in "The Lancet Neurology".
This is a multi-center, double-blind, randomized, placebo-controlled trial.
Xcopri is an effective treatment option for adult patients with controlled focal seizure epilepsy.
Clinical TrialsThe main trial (Study 017) has been published in "The Lancet Neurology".
This is a multi-center, double-blind, randomized, placebo-controlled trial.
Xcopri is an effective treatment option for adult patients with controlled focal seizure epilepsy.
During the 12-week maintenance period, all doses of Xcopri showed a significantly higher response rate (percentage of patients with a reduction of ≥50% in seizure frequency) compared to placebo.
The response rates of the 100 mg/day, 200 mg/day, and 400 mg/day groups were 40% (p=0.
036), 56% (p<0.
001), 64% (p<0.
001), respectively, while the placebo group was 25%.
In addition, during the maintenance period, 4% (no significant difference, p=0.
369), 11% (p=0.
002), and 21% (p<0.
001) of the patients who received 100mg, 200mg, and 400mg Xcopri treatments, respectively The frequency of seizures (100% seizure-free) was reduced by 100% compared to 1% in the placebo group.
The response rates of the 100 mg/day, 200 mg/day, and 400 mg/day groups were 40% (p=0.
036), 56% (p<0.
001), 64% (p<0.
001), respectively, while the placebo group was 25%.
In addition, during the maintenance period, 4% (no significant difference, p=0.
369), 11% (p=0.
002), and 21% (p<0.
001) of the patients who received 100mg, 200mg, and 400mg Xcopri treatments, respectively The frequency of seizures (100% seizure-free) was reduced by 100% compared to 1% in the placebo group.
Molecular structure of cenobamate (picture source: mechemexpress.
cn)
cn)
In Europe, approximately 6 million people suffer from epilepsy, and approximately 40% of adults with focal-onset epilepsy continue to have seizures even after using two AED treatments, highlighting the need for new treatment options.
Seizures are usually short-term abnormal electrical activity in the brain that can cause uncontrolled movements, abnormal thinking or behavior, and abnormal feelings.
The movements may be violent, and the patient may lose consciousness.
Focal seizures start in a limited area of the brain.
Seizures are usually short-term abnormal electrical activity in the brain that can cause uncontrolled movements, abnormal thinking or behavior, and abnormal feelings.
The movements may be violent, and the patient may lose consciousness.
Focal seizures start in a limited area of the brain.
The active pharmaceutical ingredient of Ontozry/Xcopri is cenobamate, which is a sodium ion channel blocker.
At present, the exact mechanism of cenobamate's therapeutic effect is unclear, but SK Biopharmaceuticals believes that the drug reduces repetitive neuronal firing by inhibiting voltage-gated sodium current.
The drug is also a gamma-aminobutyric acid (GABAA) ion channel The positive allosteric modulator.
At present, the exact mechanism of cenobamate's therapeutic effect is unclear, but SK Biopharmaceuticals believes that the drug reduces repetitive neuronal firing by inhibiting voltage-gated sodium current.
The drug is also a gamma-aminobutyric acid (GABAA) ion channel The positive allosteric modulator.
In the United States, Xcopri is already on the market.
The drug has 6 dosage strengths and is taken once a day: 12.
5mg, 25mg, 50mg, 100mg, 200mg.
In terms of medication, Xcopri should be started at 12.
5 mg, once a day, and titrated every 2 weeks.
After the drug adjustment period, the recommended maintenance dose is 200 mg/day, but some patients may need to be adjusted to 400 mg/day, which is the maximum recommended dose.
Xcopri can be used in combination with other antiepileptic drugs or used alone.
()
The drug has 6 dosage strengths and is taken once a day: 12.
5mg, 25mg, 50mg, 100mg, 200mg.
In terms of medication, Xcopri should be started at 12.
5 mg, once a day, and titrated every 2 weeks.
After the drug adjustment period, the recommended maintenance dose is 200 mg/day, but some patients may need to be adjusted to 400 mg/day, which is the maximum recommended dose.
Xcopri can be used in combination with other antiepileptic drugs or used alone.
()
Original source: ONTOZRY® (cenobamate) receives European Commission app roval for the treatment of drug-resistant focal-onset seizures in adults
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