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News on April 12, 2021 // --Jazz Pharmaceuticals recently announced that the U.
S.
Food and Drug Administration (FDA) has accepted Xywav (sodium oxybate, potassium, magnesium, calcium, JZP-258) oral solution for the treatment of idiopathic hypersomnia (Idiopathic Hypersomnia, IH).
) Supplementary New Drug Application (sNDA) for adult patients for substantive review.
The FDA granted the sNDA a priority review, and has designated the "Prescription Drug User Fees Act" (PDUFA) target action date of August 2, 2021.
FDAS.
Food and Drug Administration (FDA) has accepted Xywav (sodium oxybate, potassium, magnesium, calcium, JZP-258) oral solution for the treatment of idiopathic hypersomnia (Idiopathic Hypersomnia, IH).
) Supplementary New Drug Application (sNDA) for adult patients for substantive review.
The FDA granted the sNDA a priority review, and has designated the "Prescription Drug User Fees Act" (PDUFA) target action date of August 2, 2021.
If approved, Xywav will be the first and only drug in the United States to treat adult patients with IH.
In July 2020, Xywav was approved by the US FDA for the treatment of cataplexy or excessive daytime sleepiness (EDS) in narcolepsy (narcolepsy) patients 7 years and older.
FDAIn July 2020, Xywav was approved by the US FDA for the treatment of cataplexy or excessive daytime sleepiness (EDS) in narcolepsy (narcolepsy) patients 7 years and older.
IH is a chronic neurological disease characterized by excessive sleepiness, uncontrollable sleep requirements, or daytime sleepiness that lasts for at least 3 months, even when sleep is adequate or prolonged at night.
According to US insurance claims data, there are more than 37,000 adult patients diagnosed with IH, but there may be more undiagnosed.
According to US insurance claims data, there are more than 37,000 adult patients diagnosed with IH, but there may be more undiagnosed.
Drowsiness (Image source: crohns-disease-probiotics.
com)
com)
The sNDA is based on the results of a multi-country, double-blind, multi-center, placebo-controlled, randomized phase 3 study.
This study evaluated the efficacy and safety of Xywav in the treatment of adult patients with idiopathic narcolepsy (IH).
The patients enrolled in the study showed excessive daytime sleepiness, which is a typical feature of idiopathic narcolepsy.
The study design included a 14-week titration and optimization period, a 2-week Xywav stable dose period, followed by 1:1 randomization to receive Xywav or placebo for 2 weeks.
After completing the double-blind, placebo-controlled treatment period, the patient entered a 24-week open-label safety extension period.
This study evaluated the efficacy and safety of Xywav in the treatment of adult patients with idiopathic narcolepsy (IH).
The patients enrolled in the study showed excessive daytime sleepiness, which is a typical feature of idiopathic narcolepsy.
The study design included a 14-week titration and optimization period, a 2-week Xywav stable dose period, followed by 1:1 randomization to receive Xywav or placebo for 2 weeks.
After completing the double-blind, placebo-controlled treatment period, the patient entered a 24-week open-label safety extension period.
All patients were treated with Xywav on the open-label titration period, and clinically significant improvements in the Epworth Sleepiness Scale (ESS) were observed.
A total of 115 patients were enrolled in the randomized withdrawal part of the study, and the impression of overall changes in patients with the primary endpoint ESS and key secondary endpoints (PGIc) and the Idiopathic Hypersomnia Severity Scale (IHSS) were measured.
Patients taking Xywav showed clinically significant efficacy maintenance in terms of ESS, PGIc and IHSS, while patients taking placebo had a highly statistically significant worsening of Xywav's condition: ESS (p<0.
0001), PGIc (p<0.
0001) , IHSS (p<0.
0001).
A total of 115 patients were enrolled in the randomized withdrawal part of the study, and the impression of overall changes in patients with the primary endpoint ESS and key secondary endpoints (PGIc) and the Idiopathic Hypersomnia Severity Scale (IHSS) were measured.
Patients taking Xywav showed clinically significant efficacy maintenance in terms of ESS, PGIc and IHSS, while patients taking placebo had a highly statistically significant worsening of Xywav's condition: ESS (p<0.
0001), PGIc (p<0.
0001) , IHSS (p<0.
0001).
The safety in this study is consistent with the known safety of Xywav, and no new safety signals have been observed in this population.
Jazz will announce the data from the Phase 3 study at the 2021 American Academy of Neurology (AAN) Annual Meeting on April 20, 2021.
Jazz will announce the data from the Phase 3 study at the 2021 American Academy of Neurology (AAN) Annual Meeting on April 20, 2021.
Xywav is a hydroxybutyrate product with a unique cationic component (calcium magnesium potassium potassium sodium), which has the same hydroxybutyrate concentration compared to the recommended dose range of 6-9 grams of sodium hydroxybutyrate, but Can reduce 92% of sodium, or about 1000-1500mg/night.
Although the exact mechanism of Xywav is still unclear, the therapeutic effect of Xywav on cataplexy and EDS is thought to be mediated by the GABAB action on noradrenergic and dopaminergic neurons and thalamic cortical neurons during sleep.
Although the exact mechanism of Xywav is still unclear, the therapeutic effect of Xywav on cataplexy and EDS is thought to be mediated by the GABAB action on noradrenergic and dopaminergic neurons and thalamic cortical neurons during sleep.
Sodium oxybate contains a warning of high sodium content.
It was previously the only product approved for the treatment of cataplexy and EDS in narcolepsy patients 7 years and older, and was designated by the American Academy of Sleep Medicine (AASM) as a treatment for cataplexy and EDS The standard of care.
It was previously the only product approved for the treatment of cataplexy and EDS in narcolepsy patients 7 years and older, and was designated by the American Academy of Sleep Medicine (AASM) as a treatment for cataplexy and EDS The standard of care.
In July 2020, Xywav was approved by the US FDA for the treatment of cataplexy or excessive daytime sleepiness (EDS) in narcolepsy (narcolepsy) patients 7 years and older.
FDANarcolepsy (narcolepsy) is an incurable chronic neurological disease.
Over time, the burden of disease can have a profound impact on the health of patients.
Many patients may experience several years before getting the correct diagnosis , which can have a significant impact on their daily lives.
The disease is a lifelong disease, so it is very important to have new options to help treat EDS and cataplexy.
diagnosisOver time, the burden of disease can have a profound impact on the health of patients.
Many patients may experience several years before getting the correct diagnosis , which can have a significant impact on their daily lives.
The disease is a lifelong disease, so it is very important to have new options to help treat EDS and cataplexy.
Xywav was developed specifically to provide low-sodium oxybutyric acid therapy for narcolepsy patients, and there is no warning about sodium content, the drug will become a new standard of care.
For adult and pediatric patients, Xywav has a variety of dosage regimens to choose from.
Prescribers can titrate Xywav into different doses for patients to take at night.
When patients switch from sodium oxybate to Xywav treatment, the initial therapeutic dose and schedule of Xywav are the same as sodium oxybate (in grams to grams), and can be titrated as needed based on the efficacy and tolerability.
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For adult and pediatric patients, Xywav has a variety of dosage regimens to choose from.
Prescribers can titrate Xywav into different doses for patients to take at night.
When patients switch from sodium oxybate to Xywav treatment, the initial therapeutic dose and schedule of Xywav are the same as sodium oxybate (in grams to grams), and can be titrated as needed based on the efficacy and tolerability.
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Original source: Jazz Pharmaceuticals Announces FDA Acceptance and Priority Review of Supplemental New Drug app lication for Xywav™ (calcium, magnesium, potassium, and sodium oxybates) Oral Solution in Idiopathic Hypersomnia
FDA app 
