Jazz Pharma to Present Abstracts from Ongoing Evaluations of Xyrem®at SLEEP 2015

Jazz Pharmaceuticals will present abstracts related to the ongoing clinical evaluation of Xyrem® (sodium oxybate) oral solution, a U.S. FDA approved treatment for both excessive daytime sleepiness (EDS) and cataplexy in narcolepsy, at the 29th Annual SLEEP Meeting of the Associated Professional Sleep Societies (APSS), June 6-10, 2015 in Seattle, Washington.

“Xyrem is used to treat two common symptoms of narcolepsy — cataplexy and EDS. The abstracts to be presented at SLEEP 2015 demonstrate Jazz’s commitment to continuing clinical research that will help increase the sleep community’s scientific and clinical understanding of the role of Xyrem in the treatment of patients with narcolepsy,” said Jed Black, M.D., vice president, Sleep Medicine, Jazz Pharmaceuticals, and consulting associate professor, Stanford University Medical Center, Stanford Center for Sleep Sciences and Medicine.

Highlights from four Jazz-sponsored abstracts to be presented as posters in the Narcolepsy and Hypersomnia (P26) and in the Sleep Disorders, Other Than Sleep Disordered Breathing, in Children (P08) sessions follow:

• Evaluation of Quality-of-Life in Patients with Narcolepsy Treated with Sodium Oxybate: Use of the 36-Item Short-Form Health Survey in a Clinical Trial [Abstract # 0764, Poster # 252, Tuesday June 9, 4-6 PM, Washington State Convention Center Exhibit Hall 4AB] Richard K. Bogan, M.D., will present previously unpublished quality-of-life data from a 36-item Short-Form Health Survey (SF-36) used to measure the impact of Xyrem on key quality of life measures in patients with narcolepsy. Dr. Bogan is Associate Clinical Professor at the University of South Carolina School of Medicine and Chief Medical Officer of SleepMed Inc.
• Sodium Oxybate Treatment in Patients with Narcolepsy Stratified by the Presence of Cataplexy: Retrospective Subgroup Analysis of a Randomized Clinical Trial [Abstract # 0765, Poster # 253, Tuesday June 9, 4-6 PM, Washington State Convention Center Exhibit Hall 4AB] Dr. Jed Black will present a retrospective analysis of data from a Phase 3 study of Xyrem given alone or in combination with modafinil in patients with narcolepsy with and without cataplexy.
• Design of the First Study Evaluating Efficacy, Safety, and Pharmacokinetics of Sodium Oxybate for the Treatment of Pediatric Patients with Narcolepsy with Cataplexy [Abstract # 1098, Poster # 151, Monday June 8, 4-6 PM, Washington State Convention Center Exhibit Hall 4AB] Y. Grace Wang, M.D., will present the design of the ongoing Phase 3 study of Xyrem in children and adolescents with narcolepsy with cataplexy. This study is currently enrolling patients and is registered at www.clinicaltrials.gov (NCT 02221869). Dr. Wang is Sr. Director, Clinical Development at Jazz Pharmaceuticals.
• Developing Outcome Measures for Assessing Narcolepsy with Cataplexy in Children and Adolescents [Abstract # 1097, Poster # 150, Monday June 8, 4-6 PM, Washington State Convention Center Exhibit Hall 4AB] Dr. Wang will share results of an evaluation of the adequacy of the current measures of cataplexy and EDS in a pediatric population. This evaluation helped inform how to measure an effective response to treatment among a pediatric population in the ongoing Phase 3 study of Xyrem in children and adolescents with narcolepsy with cataplexy.

 

SLEEP 2015 is the largest gathering of sleep medicine physicians, sleep and circadian researchers, and allied health professionals in the sleep field. More details about SLEEP 2015, including abstracts, are available at https://www.sleepmeeting.org/

Xyrem® (sodium oxybate) oral solution, CIII, is indicated for the treatment of cataplexy in narcolepsy and for the treatment of excessive daytime sleepiness (EDS) in narcolepsy. Xyrem may only be dispensed to patients enrolled in the Xyrem Success Program®. Xyrem was first approved in the U.S. in 2002. Safety and effectiveness in pediatric patients have not been established.