Cataplexy

Jazz Pharmaceuticals Announces FDA Acceptance of Supplemental New Drug Application for Xyrem® (sodium oxybate) to Treat Cataplexy and Excessive Daytime Sleepiness in Pediatric Narcolepsy Patients

Retrieved on: 
Wednesday, June 27, 2018
Health, Sleep disorders, Medicine, Clinical medicine, GHB, Narcolepsy, Sodium oxybate, Excessive daytime sleepiness, Cataplexy, Prescription Drug User Fee Act, Stimulant, Food and Drug Administration

The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is October 27, 2018.

Key Points: 
  • The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is October 27, 2018.
  • "There has been a great deal of interest from the narcolepsy community in understanding the safety and efficacy of Xyrem in pediatric patients.
  • Almost all of the patients who received Xyrem during clinical trials in narcolepsy were receiving central nervous system stimulants.
  • Of the five key symptoms of narcolepsy, excessive daytime sleepiness and cataplexy are the most common symptoms.

Jazz Pharmaceuticals Presents Long-Term Safety and Efficacy Data for Xyrem® (sodium oxybate) in Pediatric Patients with Narcolepsy with Cataplexy

Retrieved on: 
Sunday, June 3, 2018
Neurochemistry, Medicine, Neuroscience, Sleep disorders, GHB, Amphetamine, Narcolepsy, RTT, Cataplexy, Sodium oxybate, gamma-Hydroxybutyric acid, Excessive daytime sleepiness

The efficacy of sodium oxybatefor cataplexy and EDS in pediatric narcolepsy was demonstrated after the two-week double-blind placebo-controlled treatment period and was maintained during open label treatment.

Key Points: 
  • The efficacy of sodium oxybatefor cataplexy and EDS in pediatric narcolepsy was demonstrated after the two-week double-blind placebo-controlled treatment period and was maintained during open label treatment.
  • The median (Q1, Q3) change from baseline in weekly number of cataplexy attacks was 0.0 (-2.25, 4.17) at study end, with little change throughout.
  • Top-line efficacy results and preliminary safety findings from the EXPRESS study were recently published in The Lancet Child & Adolescent Health.
  • Almost all of the patients who received Xyrem during clinical trials in narcolepsy were receiving central nervous system stimulants.

Jazz Pharmaceuticals Presents Long-Term Safety and Efficacy Data for Xyrem® (sodium oxybate) in Pediatric Patients with Narcolepsy with Cataplexy

Retrieved on: 
Sunday, June 3, 2018
Neurochemistry, Medicine, Neuroscience, Sleep disorders, GHB, Amphetamine, Narcolepsy, RTT, Cataplexy, Sodium oxybate, gamma-Hydroxybutyric acid, Excessive daytime sleepiness

The efficacy of sodium oxybatefor cataplexy and EDS in pediatric narcolepsy was demonstrated after the two-week double-blind placebo-controlled treatment period and was maintained during open label treatment.

Key Points: 
  • The efficacy of sodium oxybatefor cataplexy and EDS in pediatric narcolepsy was demonstrated after the two-week double-blind placebo-controlled treatment period and was maintained during open label treatment.
  • The median (Q1, Q3) change from baseline in weekly number of cataplexy attacks was 0.0 (-2.25, 4.17) at study end, with little change throughout.
  • Top-line efficacy results and preliminary safety findings from the EXPRESS study were recently published in The Lancet Child & Adolescent Health.
  • Almost all of the patients who received Xyrem during clinical trials in narcolepsy were receiving central nervous system stimulants.

Harmony Biosciences To Present Data On Its Investigational Product, Pitolisant, At Upcoming SLEEP Annual Meeting

Retrieved on: 
Thursday, May 31, 2018
Sleep disorders, Neuroscience, Biology, Nervous system, Cataplexy, Rapid eye movement sleep, Excessive daytime sleepiness, Sleep, Narcolepsy

Harmony Biosciences announced on May 21, 2018 that the company received Breakthrough Therapy and Fast Track designations for pitolisant from the U.S. Food and Drug Administration.

Key Points: 
  • Harmony Biosciences announced on May 21, 2018 that the company received Breakthrough Therapy and Fast Track designations for pitolisant from the U.S. Food and Drug Administration.
  • It is characterized by excessive daytime sleepiness and elements of rapid eye movement (REM) sleep (e.g., cataplexy, sleep paralysis, hallucinations) intruding into wakefulness.
  • Harmony Biosciences, LLC, is a privately-owned biopharmaceutical company headquartered in Plymouth Meeting, PA.
  • Harmony Biosciences received the 2017 Deal of the Year Award from Life Sciences PA. For more information on Harmony Biosciences, visit www.harmonybiosciences.com .

Jazz Pharmaceuticals to Highlight Breadth of Research in Narcolepsy and Excessive Sleepiness in Obstructive Sleep Apnea at SLEEP 2018 Annual Meeting

Retrieved on: 
Thursday, May 10, 2018
Neurochemistry, Neuroscience, Medicine, GHB, Sleep disorders, Narcolepsy, Sodium oxybate, Euphoriants, Excessive daytime sleepiness, gamma-Hydroxybutyric acid, Cataplexy, Jazz Pharmaceuticals

Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to solriamfetol, excluding certain jurisdictions in Asia.

Key Points: 
  • Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to solriamfetol, excluding certain jurisdictions in Asia.
  • Xyrem (sodium oxybate) oral solution, CIII, is indicated for the treatment of cataplexy in narcolepsy and for the treatment of excessive daytime sleepiness in narcolepsy.
  • The current United States Product Insert for Xyrem indicates that safety and effectiveness in pediatric patients have not been established.
  • Almost all of the patients who received Xyrem during clinical trials in narcolepsy were receiving central nervous system stimulants.

Jazz Pharmaceuticals Submits Supplemental New Drug Application for Xyrem® (sodium oxybate) to Treat Cataplexy and Excessive Daytime Sleepiness in Pediatric Narcolepsy Patients

Retrieved on: 
Tuesday, May 1, 2018
Sleep disorders, Medicine, Neuroscience, Clinical medicine, Narcolepsy, Sodium oxybate, Excessive daytime sleepiness, Cataplexy, Somnolence, Stimulant, Idiopathic hypersomnia, Microsleep

In clinical trials at recommended doses obtundation and clinically significant respiratory depression occurred in Xyrem-treated patients.

Key Points: 
  • In clinical trials at recommended doses obtundation and clinically significant respiratory depression occurred in Xyrem-treated patients.
  • Almost all of the patients who received Xyrem during clinical trials in narcolepsy were receiving central nervous system stimulants.
  • Narcolepsy is a debilitating neurological disorder characterized by excessive sleepiness, and the inability to regulate sleep-wake cycles normally.
  • Of the five key symptoms of narcolepsy, excessive daytime sleepiness and cataplexy are the most common symptoms.