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Jazz Pharmaceuticals Data to Showcase Ongoing Sleep Medicine Research at SLEEP 2019

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DUBLIN, May 9, 2019 /PRNewswire/ -- Jazz Pharmaceuticals plc (NASDAQ:JAZZ) announced today that 14 abstracts sponsored by Jazz Pharmaceuticals and one abstract from an investigator-sponsored trial will be presented at the 33rd Annual Meeting of the Associated Professional Sleep Societies, known as "SLEEP," in San Antonio from June 8-12, 2019.

"Jazz is committed to making meaningful strides in researching medicines that can improve the lives of people living with sleep disorders," said Jed Black, M.D., senior vice president, Sleep and CNS Medicine at Jazz Pharmaceuticals and adjunct professor, Stanford University Medical Center, Stanford Center for Sleep Sciences and Medicine. "There continue to be large unmet needs in these patient populations, and we are looking forward to presenting new data from our sleep portfolio, including our newest sleep medicine to be approved by FDA, solriamfetol."

On March 20, 2019, Jazz announced that the U.S. Food and Drug Administration (FDA) approved Sunosi™ (solriamfetol) to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). Sunosi is expected to be commercially available in the U.S. following the final scheduling decision by the U.S. Drug Enforcement Administration (DEA), which is typically within 90 days of FDA approval.

Highlights at SLEEP will include the following poster presentations:

  • Results from pooled analyses from 12-week randomized studies of solriamfetol for the treatment of excessive daytime sleepiness in patients with obstructive sleep apnea (OSA) or narcolepsy.
  • Long-term effects of solriamfetol on quality of life in patients with excessive daytime sleepiness associated with narcolepsy or OSA.
  • Treatment patterns among patients with narcolepsy treated with sodium oxybate.
  • Physician prescribing patterns for patients with narcolepsy treated with sodium oxybate.
  • Evaluation of cataplexy-free days in children/adolescents with narcolepsy with cataplexy treated with sodium oxybate.

A full list of Jazz-supported oral and poster presentations follows below:

Solriamfetol Poster Presentations

Presentation Title

Author

Date / Time / Abstract Number/ Location

Pooled Analyses from 12-Week Randomized, Controlled Studies of Solriamfetol in the Treatment Of Excessive Daytime Sleepiness In Participants With OSA Or Narcolepsy

Thorpy

et al.

Sunday, June 9

5:15 p.m. – 7:15 p.m.

0616

Bridge Hall

Long-Term Effects of Solriamfetol on Quality of Life In Participants with Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea

Weaver et al.

 

Sunday, June 9

5:15 p.m. – 7:15 p.m.

0601

Bridge Hall

Dose Titration of Solriamfetol in Participants with Obstructive Sleep Apnea (OSA) from a 6-Week Randomized-Withdrawal Trial

Strollo et al.

Tuesday, June 11

5:15 p.m. – 7:15 p.m.

0570

Bridge Hall

Weight Change Associated with Solriamfetol Treatment of Excessive Daytime Sleepiness in Participants with Narcolepsy or Obstructive Sleep Apnea

Malhotra et al.

Sunday, June 9

5:15 p.m. – 7:15 p.m.

0618

Bridge Hall

Solriamfetol Treatment of Excessive Daytime Sleepiness in Parkinson's Disease: Results from a Phase 2 Proof-of-Concept Trial

Schweitzer

et al.

Sunday, June 9

5:15 p.m. – 7:15 p.m.

0617

Bridge Hall

Incidence and Duration of Common Adverse Events in a Solriamfetol (JZP-110) Phase 3 Study for Treatment of Excessive Daytime Sleepiness in Obstructive Sleep Apnea

Rosenberg

et al.

Tuesday, June 11

5:15 p.m. – 7:15 p.m.

0569

Bridge Hall

Sodium Oxybate Presentations

Presentation Title

Author

Date / Time / Session/ Presentation Number/ Location

Treatment Patterns among Patients with Narcolepsy Treated with Sodium Oxybate

Bae et al.

Poster presentation:

Sunday, June 9

5:15 p.m. – 7:15 p.m.

0604

Bridge Hall

 

Oral presentation:

Tuesday, June 11

10:30 a.m. – 12:30 p.m.

0604 / Bridge Hall

Physician Prescribing Patterns for Patients with Narcolepsy Treated with Sodium Oxybate

Roy et al.

Sunday, June 9 

5:15 p.m. – 7:15 p.m.

0608

Bridge Hall

Dosing, Titration, and Treatment Compliance to Sodium Oxybate Therapy in Pediatric Patients With Narcolepsy

Plazzi et al.

Sunday, June 9

5:15 p.m. – 7:15 p.m.

0765

Bridge Hall

Evaluation of Cataplexy-Free Days in Children/Adolescents with Narcolepsy with Cataplexy Treated with Sodium Oxybate

Mignot et al.

Sunday, June 9

5:15 p.m. – 7:15 p.m.

0766

Bridge Hall

Long-Term Safety of Sodium Oxybate in Pediatric Narcolepsy with Cataplexy: Open-Label Continuation Post 1-Year of Treatment

Strunc et al.

Poster presentation:

Sunday, June 9

5:15 p.m. – 7:15 p.m.

0767

Bridge Hall

 

Oral presentation:

Tuesday, June 11

10:30 a.m. – 12:30 p.m.

0767

Bridge Hall

Sodium Oxybate Dosing Utilization Patterns in the Nexus Narcolepsy Registry

Ohayon et al.

Sunday, June 9

5:15 p.m. – 7:15 p.m.

0605

Bridge Hall

Patient Survey Poster Presentation

Presentation Title

Author

Date / Time / Session/
Presentation Number/ Location

Prevalence and Morbidity of Sleepiness in an Online Sleep Apnea Patient Cohort

Rottapel et al.

Tuesday, June 11

5:15 p.m. – 7:15 p.m.

0487

Bridge Hall

Narcolepsy Prevalence Poster Presentation

Presentation Title

Author

Date / Time / Session/
Presentation Number/ Location

Prevalence of Diagnosed Pediatric Narcolepsy in the United States

Morse et al.

Sunday, June 9

5:15 p.m. – 7:15 p.m.

0761

Bridge Hall

Additionally, data from the following investigator-sponsored trial focusing on sodium oxybate will be presented.

Presentation Title

Author

Date / Time / Session/ Presentation Number/ Location

Acute Total Sleep Deprivation Impairs the Ability to Manage Response Conflict

Salih et al.

Poster Presentation:

Monday, June 10

5:15 PM - 7:15 PM

0213

Bridge Hall

 

Oral Presentation:

Tuesday, June 11

1:45 PM - 2:45 PM

0213

Bridge Hall

About Sunosi™ (solriamfetol)

Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adults living with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea (OSA). In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize Sunosi from Aerial Biopharma. Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to Sunosi, excluding certain jurisdictions in Asia. SK Biopharmaceuticals, the discoverer of the compound, maintains rights in 12 Asian markets, including Korea, China and Japan. Sunosi has orphan drug designation for narcolepsy in the United States.  

Important Safety Information

SUNOSI is not for use to treat the underlying cause of airway obstruction in people with OSA. SUNOSI does not take the place of using your continuous positive airway pressure (CPAP) machine or other devices that your healthcare provider has prescribed for the treatment of OSA. It is important that you continue to use these treatments as prescribed by your healthcare provider. 

SUNOSI can be a target for people who abuse prescription medicines or street drugs. Keep SUNOSI in a safe place to protect it from theft. Never give your SUNOSI to anyone else, because it may cause death or harm them. Selling or giving away SUNOSI may harm others and is against the law. Tell your doctor if you have ever abused

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