Jazz Pharmaceuticals gets FDA nod for Xyrem for pediatric patients
Jazz Pharmaceuticals has received the green light from the Food and Drug Administration for a new indication for Xyrem (sodium oxybate) oral solution to treat cataplexy or excessive daytime sleepiness in patients with narcolepsy age seven years old and older.
"Narcolepsy is often misunderstood, misrepresented, misdiagnosed and underdiagnosed, especially in children,"Claire Crisp, Wake Up Narcolepsy executive director and mother of a child with narcolepsy, said in a statement. "This approval of Xyrem in pediatric patients is a significant step forward for the narcolepsy community as we work to elevate awareness of the condition in children and ensure patients, both pediatric and adult, have meaningful treatment options available."
"Xyrem is the only FDA-approved treatment available for excessive daytime sleepiness and cataplexy in narcolepsy for adult patients," Jed Black, Jazz Pharmaceuticals Sleep and CNS Medicine senior vice president and adjunct professor at Stanford Center for Sleep Sciences and Medicine, said in a statement. "In a pivotal study, we demonstrated both safety and efficacy of Xyrem in pediatric patients with narcolepsy. We are pleased to lead the sleep community in advancing the science and identifying meaningful treatment options for children and adolescents."
"Narcolepsy is often misunderstood, misrepresented, misdiagnosed and underdiagnosed, especially in children,"Claire Crisp, Wake Up Narcolepsy executive director and mother of a child with narcolepsy, said in a statement. "This approval of Xyrem in pediatric patients is a significant step forward for the narcolepsy community as we work to elevate awareness of the condition in children and ensure patients, both pediatric and adult, have meaningful treatment options available."
"Xyrem is the only FDA-approved treatment available for excessive daytime sleepiness and cataplexy in narcolepsy for adult patients," Jed Black, Jazz Pharmaceuticals Sleep and CNS Medicine senior vice president and adjunct professor at Stanford Center for Sleep Sciences and Medicine, said in a statement. "In a pivotal study, we demonstrated both safety and efficacy of Xyrem in pediatric patients with narcolepsy. We are pleased to lead the sleep community in advancing the science and identifying meaningful treatment options for children and adolescents."