Sunosi expected to be commercially available in the U.S.
July 2019
Investor webcast planned for July 2,
2019
DUBLIN, June 17, 2019 /PRNewswire/ -- Jazz
Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S.
Drug Enforcement Agency (DEA) has designated solriamfetol, also
known as Sunosi, as a Schedule IV medicine. With U.S. Food
and Drug Administration (FDA) approval on March 20, 2019, Sunosi is the first and
only dual-acting dopamine and norepinephrine reuptake inhibitor
(DNRI) approved to improve wakefulness in adult patients with
excessive daytime sleepiness associated with narcolepsy or
obstructive sleep apnea (OSA).
"Jazz Pharmaceuticals focuses on doing what is best for patients
and we are committed to the safe and appropriate use of our
medicines for debilitating conditions like excessive daytime
sleepiness associated with narcolepsy or OSA," said Bruce Cozadd, chairman and chief executive
officer of Jazz Pharmaceuticals. "We are pleased that Sunosi
has received a Schedule IV designation that aligns with our
research demonstrating this medicine's relatively low potential for
abuse and risk of dependence."
Beginning early July, once-daily Sunosi will be
commercially available in the U.S. in 75 mg and 150 mg
tablets.
"Excessive daytime sleepiness can have a significant impact on
the lives of people with narcolepsy or OSA. With this scheduling
decision, we move closer to commercial availability of
Sunosi, which can improve wakefulness throughout the day in
these patients," said Daniel
Swisher, president and chief operating officer of Jazz
Pharmaceuticals. "Sunosi is the first medicine that Jazz has
taken through Phase 3 development to commercialization,
further evidence of the success of our growing research and
development capabilities."
Investor Webcast Details
Jazz Pharmaceuticals will host an investor webcast for a
discussion of the narcolepsy and OSA treatment landscape and a
Sunosi U.S.launch overview from the company's senior
executive management on Tuesday, July 2,
2019. Additional details regarding the investor webcast will
be communicated in a future press release.
Sunosi is not indicated to treat the underlying airway
obstruction in OSA. Ensure that the underlying airway obstruction
is treated (e.g., with continuous positive airway pressure (CPAP))
for at least one month prior to initiating Sunosi.
Sunosi is not a substitute for these modalities, and
the treatment of the underlying airway obstruction should be
continued.
More information about Sunosi, including
Full Prescribing Information and Medication Guide, is available
here.
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 (solriamfetol) is available in 75 mg and 150 mg
tablets and is a federally controlled substance (C-IV) because it
contains solriamfetol that 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 or sell your SUNOSI to
anyone else, because it may cause death or harm them and it is
against the law. Tell your doctor if you have ever abused or
been dependent on alcohol, prescription medicines, or street
drugs.
Before taking SUNOSI, tell your doctor about all of your
medical conditions, including if you:
- have heart problems, high blood pressure, kidney problems,
diabetes, or high cholesterol
- have had a heart attack or a stroke
- have a history of mental health problems (including psychosis
and bipolar disorders), or of drug or alcohol abuse or
addiction
- are pregnant or planning to become pregnant. It is not known if
SUNOSI will harm your unborn baby
- are breastfeeding or plan to breastfeed. It is not known if
SUNOSI passes into your breast milk. Talk to your doctor about the
best way to feed your baby if you take SUNOSI.
What are the possible side effects of SUNOSI?
SUNOSI may cause serious side effects,
including:
- Increased blood pressure and heart rate. SUNOSI can
cause blood pressure and heart rate increases that can increase the
risk of heart attack, stroke, heart failure, and death. Your doctor
should check your blood pressure before and during treatment with
SUNOSI. Your doctor may decrease your dose or tell you to stop
taking SUNOSI if you develop high blood pressure that does not go
away during treatment with SUNOSI.
- Mental (psychiatric) symptoms including anxiety, problems
sleeping (insomnia), irritability, and agitation. Tell your
doctor if you develop any of these symptoms. Your doctor may change
your dose or tell you to stop taking SUNOSI if you develop side
effects during treatment with SUNOSI.
The most common side effects of SUNOSI include:
- headache
- decreased appetite
- problems sleeping
- nausea
- anxiety
These are not all the possible side effects of SUNOSI. Call your
doctor for advice about side effects.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
About Obstructive Sleep Apnea and Excessive Daytime
Sleepiness
Obstructive sleep apnea, commonly referred to as sleep apnea, is a
highly prevalent disease (as high as 14% in men and 5% in women) in
which excessive daytime sleepiness is a major presenting complaint
in many cases.1-4 Positive Airway Pressure (PAP)
therapy, with its most common form being Continuous Positive Airway
Pressure (CPAP), has been shown to be an effective therapy for
sleep apnea that frequently results in improvement in excessive
daytime sleepiness in many patients; however, not all patients
tolerate CPAP therapy and among those who tolerate CPAP, usage is
highly variable. Excessive daytime sleepiness may persist in people
with sleep apnea despite using CPAP.
About Narcolepsy
Narcolepsy is a chronic, debilitating neurological disorder
characterized by excessive daytime sleepiness, and the inability to
regulate sleep-wake cycles normally.5 It affects an
estimated one in 2,000 people in the
United States, with symptoms typically appearing in
childhood. It is estimated that more than 50% of patients with
narcolepsy have not been diagnosed.6 Studies have shown
it may take 10 years or more for people with narcolepsy to receive
a diagnosis.7 Excessive daytime sleepiness is the
primary symptom of narcolepsy and is present in all people with the
disorder.8 Excessive daytime sleepiness is characterized
by the inability to stay awake and alert during the day resulting
in unplanned lapses into sleep or drowsiness.6,8,9 There
are five primary symptoms of narcolepsy, including excessive
daytime sleepiness, cataplexy, sleep-related hallucinations, sleep
paralysis and sleep disruption. While all patients with narcolepsy
experience excessive daytime sleepiness, they may not experience
all five symptoms.
About Jazz Pharmaceuticals plc
Jazz Pharmaceuticals plc (Nasdaq: JAZZ), a global biopharmaceutical
company, is dedicated to developing life-changing medicines for
people with limited or no options. As a leader in sleep medicine
and with a growing hematology/oncology portfolio, Jazz has a
diverse portfolio of products and product candidates in
development, and is focused on transforming biopharmaceutical
discoveries into novel medicines. Jazz Pharmaceuticals markets
SunosiTM (solriamfetol), Xyrem® (sodium
oxybate) oral solution, Defitelio® (defibrotide sodium),
Erwinaze® (asparaginase Erwinia chrysanthemi) and
Vyxeos® (daunorubicin and cytarabine) liposome for
injection in the U.S. and markets Defitelio®
(defibrotide), Erwinase® and Vyxeos® 44
mg/100 mg powder for concentrate for solution for infusion in
countries outside the U.S. For country-specific product
information, please visit https://www.jazzpharma.com/medicines. For
more information, please visit www.jazzpharmaceuticals.com and
follow us on Twitter at @JazzPharma.
"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 potential benefits of
Sunosi, the expected timing of commercial availability of
Sunosi in the U.S., 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: the company's ability to effectively commercialize
Sunosi in the U.S.; delays or problems in the supply or
manufacture of Sunosi; obtaining and maintaining appropriate
pricing and reimbursement for Sunosi; complying with
applicable U.S. regulatory requirements; and other risks and
uncertainties affecting the company, 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, 2019 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.
References:
1. Sleepfoundation.org. (2019). Sleep
Apnea | National Sleep Foundation. [online] Available at:
https://www.sleepfoundation.org/sleep-disorders-problems/sleep-apnea
[Accessed 13 Mar. 2019].
2. American Academy of Sleep Medicine. The International
Classification of Sleep Disorders. Third Edition (ICSD-3). 2014.
Data on File (SOL-2018-017,020-021,023, 028, 030-032).
Palo Alto, CA: Jazz
Pharmaceuticals, Inc.
3. Peppard AE, et al. Increased Prevalence of Sleep-Disordered
Breathing in Adults. Am J Epidemiol. 2013;177(9):1006-1014.
4. Ye, L. (2014). The different clinical faces of obstructive sleep
apnoea: a cluster analysis. European Respiratory Journal,
6(1600-7), 1602-1603.
5. Thorpy, M. and Krieger, A. (2014). Delayed diagnosis of
narcolepsy: characterization and impact. Sleep Medicine, 15(5),
pp.502-507.
6. Ahmed I, Thorpy, M. Clinical Features, Diagnosis and Treatment
of Narcolepsy. Clin Chest Med. 2010;31(2):371-381.
7. Morrish E, King M, et al. Factors associated with a delay in the
diagnosis of narcolepsy. Sleep Medicine. 2004;5(1):37-41.
8. Sateia, M. (2014). International Classification of Sleep
Disorders-Third Edition. Chest, 146(5), pp.1387-1394.
9. Ahmed I, Thorpy, M. Sleepiness: Causes, Consequences and
Treatment, ed. Cambridge University
Press. 2011:36-49.
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