Twelve Jazz-Sponsored Oral and Poster Presentations To Be
Presented
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
31st 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:
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JZP-110-related
Poster Presentations
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Presentation
Title
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Author
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Presentation
Date/Time
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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
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K. Zomorodi et
al
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Poster
Presentation
- Sunday Jun 4, 2017 5:00 - 7:00 p.m.
- Abstract Number: 1027
- Poster Number: 291
- Session ID: P11
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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
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C. Stepnowsky et
al
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Poster
Presentation
- Sunday Jun 4, 2017 5:00 - 7:00 p.m.
- Abstract Number: 0457
- Poster Number: 41
- Session ID: P02
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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
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M. Thorpy et
al
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Poster
presentation
- Tuesday Jun 6, 2017 5:00 ‐ 7:00 p.m.
- Abstract Number: 0675
- Poster Number: 106
- Session ID: P28
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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
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P. Schweitzer et
al
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Poster
presentation
- Tuesday Jun 6, 2017 5:00 PM - 7:00 p.m.
- Abstract Number: 0641
- Poster Number: 349
- Session ID: P36
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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
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H. Benes et
al
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Poster
Presentation
- Tuesday Jun 6, 2017 5:00 PM - 7:00 p.m.
- Abstract Number: 0642
- Poster Number: 350
- Session ID: P36
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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
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R. Bogan et
al
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Poster
presentation
- Tuesday Jun 6, 2017 5:00 ‐ 7:00 p.m.
- Abstract Number: 0638
- Poster Number: 110
- Session ID: P28
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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
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P. Strollo et
al
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Poster
Presentation
- Tuesday Jun 6, 2017 5:00 ‐ 7:00 p.m.
- Abstract Number: 0644
- Poster Number: 352
- Session ID: P36
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Sodium Oxybate /
Narcolepsy-related Oral and Poster Presentations
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Presentation
Title
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Author
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Presentation
Date/Time
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A Double-Blind,
Placebo-Controlled, Randomized-Withdrawal, Multicenter Study on the
Efficacy and Safety of Sodium Oxybate in Pediatric Subjects with
Narcolepsy with Cataplexy
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G. Plazzi et
al
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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
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Efficacy of Sodium
Oxybate for Treatment of Excessive Daytime Sleepiness in
Narcolepsy: Meta-Analysis of Randomized Controlled
Trials
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M. Erman et
al
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Poster
Presentation
- Tuesday Jun 6, 2017 5:00 ‐ 7:00 p.m.
- Abstract Number: 0674
- Poster Number: 105
- Session Number: P28
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Factors Associated
with Use of Different Narcolepsy Medications and Medication
Discontinuation Rates: Findings from the Nexus Narcolepsy
Registry
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D. Pasta et
al
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Poster
Presentation
- Tuesday Jun 6, 2017 5:00 - 7:00 p.m.
- Abstract Number: 0676
- Poster Number: 107
- Session ID: P28
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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
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A. Husain et
al
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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
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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
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K. Villa et
al
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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
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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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