Jazz Pharmaceuticals plc will present 20 abstracts spanning the company’s sleep portfolio at SLEEP 2018.
“Jazz continues to invest in its pipeline and portfolio to deliver therapeutic options for the sleep community, and the breadth of data we are presenting at SLEEP is a testament to our substantial commitment to sleep medicine,” says Jed Black, MD, senior vice president, sleep and CNS medicine at Jazz Pharmaceuticals and adjunct professor, Stanford University Medical Center, Stanford Center for Sleep Sciences and Medicine, in a release. “We are particularly enthusiastic about our investigational medicine solriamfetol, which, if approved by the US Food and Drug Administration, will offer patients a new and robust treatment option, and the first new chemical entity for the treatment of excessive sleepiness in narcolepsy and OSA in the US in nearly 10 years.”
On March 2, 2018, Jazz announced that the US Food and Drug Administration (FDA) accepted for filing with standard review the company’s New Drug Application (NDA) seeking marketing approval for solriamfetol (JZP-110), an investigational medicine for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA).
Highlights at SLEEP will include:
- Oral and poster presentations on results from an open-label, long-term safety and maintenance of efficacy study (TONES 5) of solriamfetol in the treatment of excessive sleepiness in patients with narcolepsy or OSA.
- Oral and poster presentations examining the impact of solriamfetol on wakefulness throughout the day from the Phase 3 TONES 2 and TONES 3 studies.
- Oral and poster presentations on post-hoc efficacy and safety analyses from the Phase 3 TONES 2 study for solriamfetol for excessive sleepiness in OSA, stratified by baseline cataplexy status.
- Oral and poster presentations regarding the impact of narcolepsy and OSA on work productivity and quality of life.
- Oral and poster presentations on the long-term safety and efficacy data from the Phase 2/3 study evaluating sodium oxybate in the treatment of pediatric patients with narcolepsy.
- Poster on supporting safety for patients diagnosed with narcolepsy by restricting distribution of sodium oxybate to a central pharmacy using a central database and longitudinal monitoring.
A full list of Jazz-supported oral and poster presentations covering solriamfetol and sodium oxybate follows below:
Solriamfetol (JZP-110) Oral and Poster Presentations
- A Long-Term Safety and Maintenance of Efficacy Study of Solriamfetol (JZP-110) in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy or Obstructive Sleep Apnea
- Solriamfetol (JZP-110) in the Treatment of Excessive Sleepiness in Narcoleptic Patients With and Without Cataplexy: Results From a Randomized, Phase 3, Clinical Trial
- Solriamfetol (JZP-110) in the Treatment of Excessive Sleepiness in Narcolepsy and Obstructive Sleep Apnea: Maintenance of Wakefulness Test Results Across the Day
- Measures of Function, Work Productivity, and Quality of Life From a Phase 3 Study of Solriamfetol (JZP-110) in Patients with Narcolepsy
- Impacts of Excessive Sleepiness Associated With Obstructive Sleep Apnea on Work Productivity
- Using Multiple Anchor-based And Distribution-based Estimates To Determine The Minimal Important Difference (MID) For The FOSQ-10
- US Healthcare Claims Analysis of Obstructive Sleep Apnea Comorbidities and Their Association with Stimulant Drug Use
Sodium oxybate / Narcolepsy-related Oral and Poster Presentations
- Sodium Oxybate Treatment of Pediatric Narcolepsy: Effects on Weight, Height, and Pubertal Development
- Sodium Oxybate Treatment of Narcolepsy in Pediatric Patients: Long-term Efficacy and Safety
- Pharmacokinetics of Sodium Oxybate in Children and Adolescents with Narcolepsy with Cataplexy
- Clinical and Patient Global Impression in a Phase 2/3 Study of Sodium Oxybate in Children and Adolescents with Narcolepsy with Cataplexy
- Injuries, Motor Vehicle Accidents, and Near Misses in Narcolepsy: Results from the Nexus Narcolepsy Registry
- Disease Burden in Pediatric Narcolepsy: a Claims-based Analysis of Healthcare Utilization and Costs, and Medical Comorbidity
- Predictors of Time to Narcolepsy Diagnosis in Participants with Adult Onset of Symptoms: Results from the Nexus Narcolepsy Registry
- US Prevalence of Narcolepsy and Other Sleep Disorders From 2013-2016: a Retrospective, Epidemiological Study Utilizing Nationwide Claims
- Supporting Safety for Patients Diagnosed with Narcolepsy by Restricting Distribution of Sodium Oxybate to a Central Pharmacy Using a Central Database and Longitudinal Monitoring
The following investigator-sponsored trials focusing on sodium oxybate also will be presented:
- Defining Disrupted Nighttime Sleep in Pediatric Narcolepsy
- Role of diet in modulating the effects of sodium oxybate on weight gain in male Sprague-Dawley rats
- Diagnostic Accuracy and Validity of the Swiss Narcolepsy Scale for the Diagnosis of Type 1 and Type 2 Narcolepsy Against Other Central Disorders of Hypersomnolence
- The Bern Sleep-Wake Registry: Demographics And Clinical Characteristics of the First 6,831 Patients