JAZZ PHARMACEUTICALS PLC DUBLIN, Ireland, May 24, 2017 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced today that twelve abstracts supporting the company's sleep medicine portfolio, including data on its investigational compound JZP-110, data on the investigational use of sodium oxybate for the treatment of cataplexy and excessive daytime sleepiness in pediatric patients with narcolepsy, and data from the Nexus narcolepsy patient registry, will be presented at the 31(st) Associated Professional Sleep Societies (APSS) Annual SLEEP Meeting June 3-7 in Boston, MA.
"Developing innovative treatments for often overlooked and debilitating conditions is one of our highest priorities," said Karen Smith, M.D., Ph.D., executive vice president, research and development and chief medical officer at Jazz Pharmaceuticals. "The breadth of data that we will be presenting at the SLEEP 2017 meeting reflects our ongoing commitment to advancing meaningful treatments that address unmet needs in sleep medicine, including for patients living with narcolepsy and obstructive sleep apnea (OSA)."
Key presentations include data from the Treatment of OSA and Narcolepsy Excessive Sleepiness (TONES) Phase 3 program for JZP-110, an investigational wake-promoting agent in development for the treatment of excessive sleepiness in adult patients with narcolepsy (TONES 2) or OSA (TONES 3 and TONES 4), Phase 2/3 data from a clinical study evaluating sodium oxybate in pediatric patients aged 7-17, and new data from the Jazz-sponsored Nexus Narcolepsy Registry, the first narcolepsy-specific, web-based registry of patient-reported data.
A full list of Jazz-supported oral and poster presentations follows below:
JZP-110-related Poster Presentations
Presentation Title Author Presentation Date/Time
------------------ ------ ----------------------
An Open-Label, Single-Dose, Phase 1 Study
of the Pharmacokinetics and Safety of JZP-
110 in Subjects with Normal or Impaired
Renal Function and with End-Stage Renal
Disease Requiring Hemodialysis K. Zomorodi et al Poster Presentation
Sunday Jun 4, 2017 5:00 -7:00 p.m.
Abstract
Number: 1027
Poster Number: 291
Session ID:
P11
---------------------------------------------
Comorbidities and Health-related Quality of
Life Among People with Sleep Apnea with
Excessive Daytime Sleepiness: Findings from
the 2016 US National Health and Wellness
Survey C. Stepnowsky et al Poster Presentation
Sunday Jun 4, 2017 5:00 -7:00 p.m.
Abstract
Number: 0457
Poster Number: 41
Session ID:
P02
---------------------------------------------
A Randomized, Placebo-Controlled, Phase 3
Study of the Safety and Efficacy of JZP-110
for the Treatment of Excessive Sleepiness in
Patients with Narcolepsy M. Thorpy et al Poster presentation
Tuesday Jun 6, 2017 5:00 ? 7:00 p.m.
Abstract
Number: 0675
Poster Number: 106
Session ID:
P28
-----------------------------------------------
A Phase 3, Randomized, Placebo-Controlled,
Double-Blind, 12-Week, Multicenter Study
of the Efficacy and Safety of JZP-110 for
the Treatment of Excessive Sleepiness in
Patients with Obstructive Sleep Apnea P. Schweitzer et al Poster presentation
Tuesday Jun 6, 2017 5:00 PM -7:00 p.m.
Abstract Number: 0641
Poster Number: 349
Session ID: P36
--------------------------------------------
A Phase 3, Randomized, Placebo-Controlled,
Double-Blind, Multicenter, 12-Week Study
of the Safety and Efficacy of JZP-110 in
the Treatment of Excessive Sleepiness in
Patients with Obstructive Sleep Apnea: SF-
36 and EQ-5D-5L Measures H. Benes et al Poster Presentation
Tuesday Jun 6, 2017 5:00 PM -7:00 p.m.
Abstract Number: 0642
Poster Number: 350
Session ID: P36
--------------------------------------------
Function and Work Productivity Measures in a
Phase 3, Randomized, Placebo-Controlled,
Double-Blind, Multicenter, 12-Week Study
of the Safety and Efficacy of JZP-110 for
the Treatment of Excessive Sleepiness in
Patients with Obstructive Sleep Apnea R. Bogan et al Poster presentation
Tuesday Jun 6, 2017 5:00 ? 7:00 p.m.
Abstract
Number: 0638
Poster Number: 110
Session ID:
P28
-----------------------------------------------
A Phase 3, Placebo-Controlled, Randomized-
Withdrawal, Double-Blind, 6-Week
Multicenter Study of the Safety and Efficacy
of JZP-110 for the Treatment of Excessive
Sleepiness in Participants with Obstructive
Sleep Apnea P. Strollo et al Poster Presentation
Tuesday Jun 6, 2017 5:00 ? 7:00 p.m.
Abstract
Number: 0644
Poster Number: 352
Session ID:
P36
-----------------------------------------------
Sodium Oxybate /Narcolepsy-related Oral and
Poster Presentations
Presentation Title Author Presentation Date/Time
------------------ ------ ----------------------
A Double-Blind, Placebo-Controlled,
Randomized-Withdrawal, Multicenter Study on
the Efficacy and Safety of Sodium Oxybate in
Pediatric Subjects with Narcolepsy with
Cataplexy G. Plazzi et al Oral Presentation
Monday, June 5, 2017; 11:45 a.m. -12:00 p.m.
Abstract Number: 0645
Session Number: O03
Poster Presentation
Monday, June 5, 2017; 5:00 -7:00 p.m.
Poster
Number: 181
Session Number: P18
----------------------------------------------
Efficacy of Sodium Oxybate for Treatment of
Excessive Daytime Sleepiness in Narcolepsy:
Meta-Analysis of Randomized Controlled
Trials M. Erman et al Poster Presentation
Tuesday Jun 6, 2017 5:00 ? 7:00 p.m.
Abstract
Number: 0674
Poster Number: 105
Session
Number: P28
-----------------------------------------------
Factors Associated with Use of Different
Narcolepsy Medications and Medication
Discontinuation Rates: Findings from the
Nexus Narcolepsy Registry D. Pasta et al Poster Presentation
Tuesday Jun 6, 2017 5:00 -7:00 p.m.
Abstract
Number: 0676
Poster Number: 107
Session ID:
P28
----------------------------------------------
Incidence and Duration of Common, Early-
Onset, Treatment-Emergent Adverse Events
Occurring During Two Randomized, Placebo-
Controlled, Phase 3 Studies of Sodium
Oxybate for the Treatment of Excessive
Sleepiness in Patients with Narcolepsy A. Husain et al Oral Presentation
Wednesday, June 7, 2017; 2:45 ? 3:00 p.m.
Abstract Number: 0650
Session Number: O29
Poster Presentation
Tuesday, June 6, 2017 5:00 -7:00 p.m.
Poster
Number: 113
Session Number: P28
----------------------------------------------
Assessing the Benefits of Sodium Oxybate
(SXB) on Functioning, Productivity and
Health-Related Quality of Life in People
with Narcolepsy: Findings from the Nexus
Narcolepsy Registry K. Villa et al Oral Presentation
Wednesday, June 7, 2017 3:00 -3:15 p.m.
Abstract Number: 0651
Session Number: O29
Poster Presentation
Tuesday, June 6, 2017 5:00 -7:00 p.m.
Poster
Number: 114
Session Number: P28
----------------------------------------------
Full details of the APSS annual SLEEP meeting can be found at http://www.sleepmeeting.org/.
About JZP-110
JZP-110 is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) in late-stage development for treatment of excessive sleepiness in adult patients with narcolepsy or OSA. In 2014, Jazz Pharmaceuticals acquired a world-wide license (except in certain countries in Asia) to develop and commercialize JZP-110 from SK Biopharmaceuticals, which discovered the compound. Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to JZP-110, excluding certain jurisdictions in Asia. SK Biopharmaceuticals maintains rights in Korea, Japan, China, Taiwan, Singapore, Indonesia, India, Philippines, Thailand, Malaysia, Vietnam, and Hong Kong. JZP-110 has orphan drug designation in the United States for narcolepsy.
Across the entire JZP-110 development program, over 2,000 subjects have enrolled in 20 studies. The JZP-110 Phase 3 clinical program includes one study evaluating excessive sleepiness in adult patients with narcolepsy (TONES 2), two studies evaluating excessive sleepiness in adult patients with OSA (TONES 3 and TONES 4), and an open-label, long-term safety and maintenance of efficacy study (TONES 5). Enrollment is complete in all studies that are expected to support Jazz Pharmaceuticals' planned JZP-110 New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in late 2017.
About Xyrem
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. Xyrem may only be dispensed to patients enrolled in the Xyrem REMS Program. Xyrem was first approved in the U.S. in 2002, based on clinical trial data in adults. The current United States Product Insert for Xyrem indicates that safety and effectiveness in pediatric patients have not been established. Jazz plans to submit a supplemental NDA to FDA in the fourth quarter of 2017 with revised proposed labeling to include data for use in pediatric patients, consistent with the FDA's pediatric written request.
IMPORTANT SAFETY INFORMATION
Xyrem is a central nervous system (CNS) depressant. 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.
Xyrem is the sodium salt of gamma hydroxybutyrate (GHB). Abuse of GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death.
Because of the risks of CNS depression, abuse, and misuse, Xyrem is available only through a restricted distribution program called the Xyrem REMS Program, using the central pharmacy that is specially certified. Prescribers and patients must enroll in the program. For further information go to www.XYREMREMS.com or call 1-866-XYREM88® (1-866- 997-3688).
Xyrem is contraindicated in combination with sedative hypnotics or alcohol and in patients with succinic semialdehyde dehydrogenase deficiency.
Caution should be used when considering the concurrent use of Xyrem with other CNS depressants. Healthcare providers should caution patients against hazardous activities requiring complete mental alertness or motor coordination within the first 6 hours of dosing or after first initiating treatment until certain that Xyrem does not affect them adversely. The rapid onset of sedation, coupled with the amnestic features of Xyrem, particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (e.g. assault victim). Patients should be monitored for emergent or increased depression and suicidality and for impaired motor/cognitive function. Episodes of sleepwalking should be fully evaluated and appropriate interventions considered. The amount of daily sodium intake in each dose of Xyrem should be considered in patients sensitive to salt intake. The most common adverse reactions were nausea, dizziness, vomiting, somnolence, enuresis, and tremor.
Please click here to see the full Prescribing Information for Xyrem, including BOXED Warning.
About the Nexus Narcolepsy Registry
The Nexus Narcolepsy Registry is an effort by Wake Up Narcolepsy and the narcolepsy research and advocacy communities, in collaboration with Jazz Pharmaceuticals, to collect de-identified data from a large group of people with narcolepsy over several years in order to shed light on the impact of the condition on people's lives. To learn more about the registry, please visit www.narcolepsyregistry.com.
About Jazz Pharmaceuticals plc
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. The company has a diverse portfolio of products and product candidates with a focus in the areas of sleep and hematology/oncology. In these areas, Jazz Pharmaceuticals markets Xyrem® (sodium oxybate) oral solution, Erwinaze® (asparaginase Erwinia chrysanthemi) and Defitelio® (defibrotide sodium) in the U.S. and markets Erwinase® and Defitelio® (defibrotide) in countries outside the U.S. For more information, please visit www.jazzpharmaceuticals.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to the company's commitment to advancing meaningful treatments that address unmet needs in sleep medicine, the company's plans for submission of an NDA for JZP-110 to the FDA, the company's plans for submission of a supplemental NDA to the FDA for the use of Xyrem in pediatric patients, and other statements that are not historical facts. These forward-looking statements are based on the company's current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: pharmaceutical product development and clinical success thereof; the regulatory approval process, including the risks that the company may be unable to obtain approval by the FDA for JZP-110 or for its planned supplemental NDA for Xyrem in a timely manner or at all; effectively commercializing the company's products and product candidates; and other risks and uncertainties affecting the company and its development programs, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 and future filings and reports by the company. Other risks and uncertainties of which the company is not currently aware may also affect the company's forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by the company on its website or otherwise. The company undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.
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