FDA approves innovative narcolepsy therapy on the market.

Jazz Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) approved the launch of Xywav (calcium, magnesium, potassium, and sodium hydroxybutyatis) oral solution on July 21, 2020 for the treatment of hypochonchonist disease or daytime drowsiness (EDS) in patients with narcolepsy 7 years and older.
Xywav is a sodium hydroxybutyrate product with its unique cation composition that results in sodium content 92% lower than the current standard treatment for these patients, reducing the risk of excessive sodium ion intake.
episode sleeping disorder is a chronic and rare neurological disease.
patients are unable to regulate the cycle of sleep and wake,which can lead to drowsiness.
most narcolepsy is caused by the absence of hypothalamus, a neuropeptide in the brain that supports the dynamic balance of sleep and wakefulness. the five symptoms of
onset sleep disorder include excessive daytime drowsiness, sudden seizures of muscle weakness (downfall), sleep disruption at night, sleep hallucinations, and sleep paralysis.
all people with narcolepsy will experience symptoms that do not remain awake and alert during the day.
Xywav, also known as JZP-258, is a new drug of hydroxybutarates, consisting of unique cations.
it reduced sodium content by 92% compared to Another Jazz company's central nervous system inhibitor, Xyrem(sodium hydroxybutylate), which treats seizure sleep, improving the long-term safety of the drug.
, its exact mechanism of action has not yet been confirmed.
it is speculated that JZP-258's therapeutic effect on seizure sleep ingenuity is based on the regulation of GABAB receptors during sleep.
, JZP-258 treated idiopathic hypersleep hypersomnia in Phase 3 clinical studies.
Photo Source: References, FDA-approved Xywav is based on a global, double-blind, placebo-controlled, randomized, multicenter phase 3 clinical study that demonstrates the efficacy and safety of Xywav in treating patients with seizure sleep and EDS.
the study included 201 patients and Xywav showed a highly statistically significant difference in weekly seizures and Epworth sleepiness scale scores compared to the placebo group (p-lt;0.0001).
patients who continue to receive Xywav treatment have significantly fewer weekly seizures than the placebo group (pictured: JazzS) "Based on the efficacy shown in clinical programs, Xywav's approval is important for patients with dystose or drowsiness-related EDS," said Dr. Richard K. Bogan, clinical associate professor at the University of South Carolina School of Medicine and lead the stage 3 clinical trial.
excess sodium intake is associated with elevated blood pressure, high blood pressure, stroke, and other cardiovascular diseases.
"references: jazz pharmaceuticals Announces U.S. FDA Approve xywav ™ (calcium, carmup, appam, and sodium oxybates) Solution for Cataplexy or Excessive Dayday SleepySIs Yops Withyau. Retrieved Jul 22, 2020, from the original title: Express. The FDA has approved the launch of innovative narcolepsy therapy to improve long-term safety.