DUBLIN, Nov. 9, 2018 /PRNewswire/ -- Jazz
Pharmaceuticals plc (Nasdaq: JAZZ) today announced the submission
of a Marketing Authorization Application (MAA) to the European
Medicines Agency for solriamfetol, a selective dopamine and
norepinephrine reuptake inhibitor, as a treatment to improve
wakefulness and reduce excessive daytime sleepiness (EDS) in adult
patients with narcolepsy (with or without cataplexy) or obstructive
sleep apnea (OSA).
"Excessive daytime sleepiness associated with narcolepsy or
obstructive sleep apnea can be debilitating for patients and
challenging for the medical community to diagnose and treat," 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.
"Jazz is committed to addressing unmet needs in sleep medicine by
delivering meaningful treatment options."
"In the European Union, there is no approved treatment for
people with excessive daytime sleepiness associated with
obstructive sleep apnea, and people with excessive daytime
sleepiness due to narcolepsy may benefit from the availability of
new treatment options," said Professor Yves
Dauvilliers, M.D., Ph.D. Head of Sleep and Wake Disorders at
the University Hospital of Montpellier, France. "As the sleep medical community
improves its understanding and diagnosis of these conditions, it is
increasingly important that patients have multiple treatment
options available to help them manage their condition more
effectively."
Jazz has studied solriamfetol extensively via the Treatment of
OSA and Narcolepsy Excessive Sleepiness (TONES) Phase 3 program,
which was comprised of four studies that evaluated:
- solriamfetol in EDS in adult patients with narcolepsy (TONES 2)
or OSA (TONES 3 and TONES 4), and
- the long-term safety and maintenance of efficacy for
solriamfetol as a treatment for EDS in patients with narcolepsy or
OSA (TONES 5).
Jazz presented long-term safety and maintenance of efficacy
results from the TONES 5 Phase 3 study of solriamfetol in adult
patients with EDS associated with OSA or with narcolepsy at the
annual meeting of the Associated Professional Sleep Societies
(APSS) in June 2018. TONES 2, 3 and 4
data were presented at APSS in 2017.
Notes to Editors
About Obstructive Sleep Apnea and Excessive Daytime
Sleepiness
In the EU, obstructive sleep apnea (OSA) is a
prevalent disease (as high as 14% in men and 7% in women) in which
excessive daytime sleepiness is a major presenting complaint in
many cases.1 Excessive daytime sleepiness in OSA is
associated with impairments in cognitive function, safety,
productivity, interpersonal relationships, and overall quality of
life. 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-related airway
obstruction, with frequent improvement in excessive daytime
sleepiness in many patients; however, pathological sleepiness often
continues despite primary treatment of the airway obstruction with
PAP or other therapies.2-5 It is estimated that
excessive daytime sleepiness persists in one in three people
utilizing CPAP for OSA.6
About Narcolepsy and Excessive Daytime
Sleepiness
Narcolepsy is a debilitating neurological
disorder characterized by excessive daytime sleepiness, and the
inability to regulate sleep-wake cycles normally.7 It
affects an estimated one in 2,000 people in the EU,8
with symptoms typically appearing in early adulthood. Globally, it
is estimated that more than 50% of patients with narcolepsy have
not been diagnosed.9 Studies have shown it may take 10
years or more for people with narcolepsy to receive a correct
diagnosis.10 Excessive daytime sleepiness is the primary
symptom of narcolepsy and is present in all people with the
disorder.11 Excessive daytime sleepiness is
characterized by the inability to stay awake and alert during the
day, resulting in unplanned drowsiness or lapses into sleep.7,
11,12
About Solriamfetol
Solriamfetol is a selective
dopamine and norepinephrine reuptake inhibitor (DNRI) in
development for treatment of EDS in adult patients with narcolepsy,
OSA, and Parkinson's disease. In 2014, Jazz Pharmaceuticals
acquired a license to develop and commercialize solriamfetol from
Aerial Biopharma. Jazz Pharmaceuticals has worldwide development,
manufacturing, and commercialization rights to solriamfetol,
excluding certain jurisdictions in Asia. SK Biopharmaceuticals, the discoverer of
the compound, maintains rights in 12 Asian markets, including
Korea, China and Japan. Solriamfetol has orphan drug
designation in the United States
for narcolepsy. In March 2018, Jazz
announced that the U.S. Food and Drug Administration (FDA) accepted
for filing with standard review the company's New Drug Application
(NDA) seeking marketing approval for solriamfetol for the treatment
of ES in adult patients with narcolepsy or OSA. The Prescription
Drug User Fee Act (PDUFA) goal date for an FDA decision is
December 20, 2018.
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 therapeutic areas, Jazz
Pharmaceuticals markets Xyrem® (sodium oxybate) oral
solution, Erwinaze® (asparaginase Erwinia
chrysanthemi), Defitelio® (defibrotide sodium) and
Vyxeos® (daunorubicin and cytarabine) liposome for
injection in the U.S. and markets Erwinase®,
Defitelio® (defibrotide) and Vyxeos® 44
mg/100 mg powder for concentrate for solution for infusion in
countries outside the U.S.
References:
- Jennum P, Riha RL. Epidemiology of sleep apnoea/hypopnoea
syndrome and sleep-disordered breathing. Eur Respir J. 2009
Apr;33(4):907-14.
- Pepin JL, et al. Eur Resp J. 2009;33:1062–1067.
- Weaver TE, et al. Sleep. 2007;30(6):711–719.
- Gasa M, et al. J Sleep Res. 2013;22(4):389–397.
- Koutsourelakis I, et al. Eur Resp J.
2009;34(3):687–693.
- Antic N, et al. The Effect of CPAP in Normalizing Daytime
Sleepiness, Quality of Life, and Neurocognitive Function in
Patients with Moderate to Severe OSA. Sleep.
2011:34(1)111-119.
- Thorpy M, Krieger A. Delayed diagnosis of narcolepsy:
characterization and impact. Sleep Medicine.
2014;15(5):502–507.
- Ohayon MM et al. Prevalence of narcolepsy symptomatology and
diagnosis in the European general population; Neurology 2002, 58.
1826-1833.
- Ahmed I, Thorpy, M. Clinical Features, Diagnosis and Treatment
of Narcolepsy. Clin Chest Med. 2010;31(2):371-381.
- Morrish E, King M, et al. Factors associated with a delay in
the diagnosis of narcolepsy. Sleep Medicine. 2004;5(1):37-41.
- American Academy of Sleep Medicine. The International
Classification of Sleep Disorders. Third Edition (ICSD-3).
2014.
- Ahmed I, Thorpy, M. Sleepiness: Causes, Consequences and
Treatment, ed. Cambridge University
Press. 2011:36-49.
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