Actor Portrayals.

NOURIANZ® is
an add-on treatment
for “off” time

NOURIANZ works together with your current levodopa/carbidopa regimen to reduce “off” time in Parkinson’s disease (PD).

NOURIANZ is the first and only treatment for
“off” time in Parkinson’s disease (PD) that lifts
the brake of adenosine

Image of a brake pedal symbolizes adenosine which limits movement in the body

The exact way NOURIANZ works to treat
“off” time in PD is unknown,
but unlike any other
medication for PD, NOURIANZ is believed to
work
by targeting adenosine A2A receptors.

This is like lifting the brake in a car, helping to
increase movement
if you are
experiencing “off” time.

MODE OF ACTION VIDEO

Watch how NOURIANZ (istradefylline) lifts the brake of adenosine

MODE OF ACTION VIDEO

Watch how NOURIANZ (istradefylline)
lifts the brake of adenosine

NOURIANZ was shown to reduce “off” time in clinical trials

In clinical trials:

  • All patients were on levodopa. Most were also
    taking other
    PD medications. All of them were
    still experiencing “off” time
  • All patients in the trials were given NOURIANZ
    or placebo
    (sugar pill)
    in addition to their
    other PD medications

At 12 weeks, NOURIANZ reduced “off” time
significantly more than placebo
, based on
diaries of people living with PD in
clinical studies.*†

*Average “off” time at the start of the study was about 6 hours per day.
In Study 3 and Study 4.

NOURIANZ reduced “off” time by
about 1 hour per day*†

Clock and downward arrow illustrate approximately 1 hour per day reduction in “off” time shown in NOURIANZ clinical studies
  • NOURIANZ 20 mg reduced “off” time
    by 0.99-1.31 hours per day
  • NOURIANZ 40 mg reduced “off” time
    by 0.96-1.58 hours per day
  • Placebo reduced “off” time
    by 0.23-0.66 hours per day

*Average “off” time at the start of the study was about 6 hours per day.
In Study 3 and Study 4.





Additional data suggests that NOURIANZ may increase
good “on” time without uncontrolled, sudden movements

Input from the diaries of people in clinical studies
living with
Parkinson’s disease suggests that
NOURIANZ may increase good “on”
time, which is
“on” time without uncontrolled, sudden
movements at
12 weeks.
A change in good “on”
time was a secondary efficacy endpoint.

“On” time is when medication is working
to treat symptoms such as slowness, stiffness,
or issues with mobility.

In Studies 1-4.

PEOPLE TAKING NOURIANZ EXPERIENCED
AN INCREASE IN
GOOD “ON” TIME

Clock and upward arrow illustrate good “on” time shown in NOURIANZ clinical studies
  • NOURIANZ 20 mg increased “on” time
    by 1.09-1.35 hours per day
  • NOURIANZ 40 mg increased “on” time
    by
    0.21-1.29 hours per day
  • Placebo increased “on” time
    by
    0.49-0.80 hours per day

In Studies 1-4.

The safety profile
of NOURIANZ
has
been demonstrated
in multiple

clinical studies

People taking NOURIANZ
may experience:

  • Uncontrolled movements (dyskinesia)
  • Dizziness
  • Constipation
  • Nausea
  • Hallucinations
  • Problems sleeping (insomnia)

NOURIANZ and other medicines may affect
each other causing side effects.
NOURIANZ
may affect the way other medicines work,
and other medicines
may affect how
NOURIANZ works.

Talk to your doctor if you experience
any of these side effects.

An icon of a person with talk bubble

Ask your doctor if adding
NOURIANZ is right for you.

In NOURIANZ studies, the number of patients who stopped taking NOURIANZ due
to side effects was similar to that of patients taking placebo (sugar pill)

  • The incidence of patients discontinuing for any
    adverse reaction was 5% for NOURIANZ 20 mg,
    6% for NOURIANZ 40 mg, and 5% for placebo
  • 1% of patients discontinued NOURIANZ due to
    dyskinesia compared to 0% of patients on
    placebo
  • In patients treated with NOURIANZ 40 mg, 1%
    discontinued because of hallucinations
    compared to 0% for placebo and 0% for patients
    treated with NOURIANZ 20 mg

NOURIANZ, in combination with levodopa, may cause dyskinesia or exacerbate pre-existing dyskinesia. The incidence of dyskinesia was 15% for NOURIANZ 20 mg, 17% for NOURIANZ 40 mg, and 8% for placebo, in combination with levodopa.

 
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What is NOURIANZ?

NOURIANZ is a prescription medicine used with levodopa and carbidopa to treat adults with Parkinson’s disease (PD) who are having “off” episodes. It is not known if NOURIANZ is safe and effective in children.

Important Safety Information
Before you take NOURIANZ, tell your healthcare provider about all your medical conditions, including if you:
  • have a history of abnormal movement (dyskinesia)
  • have reduced liver function
  • smoke cigarettes
  • are pregnant or plan to become pregnant. NOURIANZ may harm your unborn baby
  • are breastfeeding or plan to breastfeed. It is not known if NOURIANZ passes into breast milk. You and your healthcare provider should decide if you will take NOURIANZ or breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

NOURIANZ and other medicines may affect each other causing side effects. NOURIANZ may affect the way other medicines work, and other medicines may affect how NOURIANZ works.

What are the possible side effects of NOURIANZ?
NOURIANZ may cause serious side effects, including:

  • uncontrolled sudden movements (dyskinesia). Uncontrolled sudden movements is one of the most common side effects.
  • hallucinations and other symptoms of psychosis. NOURIANZ can cause abnormal thinking and behavior, including:
    • being overly suspicious or feeling people want to harm you (paranoid ideation)
    • believing things that are not real (delusions)
    • seeing or hearing things that are not real (hallucinations)
    • confusion
    • increased activity or talking (mania)
    • disorientation
    • aggressive behavior
    • agitation
    • delirium (decreased awareness of things around you)
  • unusual urges (impulse control or compulsive behaviors). Some people taking NOURIANZ get urges to behave in a way unusual for them. Examples of this are unusual urges to gamble, increased sexual urges, strong urges to spend money, binge eating, and the inability to control these urges.

If you notice or your family notices that you are developing any new or unusual symptoms or behaviors, talk to your healthcare provider.

The most common side effects of NOURIANZ include uncontrolled movements (dyskinesia), dizziness, constipation, nausea, hallucinations, and problems sleeping (insomnia).

These are not all the possible side effects of NOURIANZ.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Patient Information for NOURIANZ.

References: 1.NOURIANZ. Prescribing Information. Kyowa Kirin, Inc; 2020. Accessed April 1, 2021. https://www.nourianzhcp.com/assets/pdf/nourianz-full-prescribing-information.pdf. 2.Kalia LV, Brotchie JM, Fox SH. Novel nondopaminergic targets for motor features of Parkinson’s disease: review of recent trials. Mov Disord. 2013;28(2):131-144.

References: 1. Kalia LV, Brotchie JM, Fox SH. Novel nondopaminergic targets for motor features of Parkinson's disease: review of recent trials. Mov Disord. 2013;28(2):131-144. 2. Mori A. Mode of action of adenosine A2A receptor antagonists as symptomatic treatment for Parkinson’s disease. Int Rev Neurobiol. 2014;119:87-116. 3. Varani K, Vincenzi F, Tosi A, et al. A2A adenosine receptor overexpression and functionality, as well as TNF-α levels, correlate with motor symptoms in Parkinson’s disease. FASEB J. 2010;24(2):587-598. doi:10.1096/fj.09-141044. 4. Fuxe K, Marcellino D, Genedani S, Agnati L. Adenosine A2A receptors, dopamine D2 receptors and their interactions in Parkinson's disease. Mov Disord. 2007;22(14):1990-2017. doi: 10.1002/mds.21440. 5. Morelli M, Di Paolo T, Wardas J, Calon F, Xiao D, Schwarzschild MA. Role of adenosine A2A receptors in parkinsonian motor impairment and L-DOPA-induced motor complications. Prog Neurobiol. 2007;83(5):293-309. 6. Morelli M, Blandini F, Simola N, Hauser RA. A2A receptor antagonism and dyskinesia in Parkinson's disease. Parkinsons Dis. 2012;2012:489853. doi: 10.1155/2012/489853. 7. Mishina M, Ishiwata K. Adenosine receptor PET imaging in human brain. Int Rev Neurobiol. 2014;119:51-69. doi:10.1016/B978-0-12-801022-8.00002-7. 8. The voice of the patient: Parkinson’s disease. Silver Spring, MD: US Food and Drug Administration; April 2016. https://www.fda.gov/media/124392/download. Accessed June 11, 2019. 9. Hickey P, Stacy M. Available and emerging treatments for Parkinson’s disease: a review. Drug Des Devel Ther. 2011;5:241-254. 10. Stocchi F, Antonini A, Barone P, et al. Early DEtection of wEaring off in Parkinson disease: the DEEP study. Parkinsonism Relat Disord. 2014;20(2):204-211.

References: 1. NOURIANZ. Prescribing Information. Kyowa Kirin, Inc; 2020. Accessed April 1, 2021. https://www.nourianzhcp.com/assets/pdf/nourianz-full-prescribing-information.pdf 2. Kalia LV, Brotchie JM, Fox SH. Novel nondopaminergic targets for motor features of Parkinson’s disease: review of recent trials. Mov Disord. 2013;28(2):131-144. 3. Jenner P. Istradefylline, a novel adenosine A2A receptor antagonist, for the treatment of Parkinson’s disease. Expert Opin Investig Drugs. 2005;14(6):729-738. 4. Brichta L, Greengard P, Flajolet M. Advances in the pharmacological treatment of Parkinson’s disease: targeting neurotransmitter systems. Trends Neurosci. 2013;36(9):543-554. 5. Kaakkola S, Wurtman RJ. Effects of COMT inhibitors on striatal dopamine metabolism: a microdialysis study. Brain Res. 1992;587(2):241-249. 6. Kong P, Zhang B, Lei P, et al. Neuroprotection of MAO-B inhibitor and dopamine agonist in Parkinson disease. Int J Clin Exp Med. 2015;8(1):431-439. 7. Ossola B, Schendzielorz N, Chen SH, et al. Amantadine protects dopamine neurons by a dual action: reducing activation of microglia and inducing expression of GDNF in astroglia. Neuropharmacology. 2011;61(4):574-582. 8. Rubí B, Maechler P. Minireview: new roles for peripheral dopamine on metabolic control and tumor growth: let’s seek the balance. Endocrinology. 2010;151(12):5570-5581. doi:10.1210/en.2010-0745. 9. Gerlach M, Double K, Arzberger T, Leblhuber F, Tatschner T, Riederer P. Dopamine receptor agonists in current clinical use: comparative dopamine receptor binding profiles defined in the human striatum. J Neural Transm (Vienna). 2003;110(10):1119-1127. 10. Ishibashi K, Miura Y, Wagatsuma K, Toyohara J, Ishiwata K, Ishii K. Adenosine A2A receptor occupancy by long-term istradefylline administration in Parkinson’s disease. Mov Disord. 2021;36(1):268-269. doi:10.1002/mds.28378.

References: 1. NOURIANZ. Prescribing Information. Kyowa Kirin, Inc; 2020. Accessed April 1, 2021. https://www.nourianzhcp.com/assets/pdf/nourianz-full-prescribing-information.pdf 2. Kalia LV, Brotchie JM, Fox SH. Novel nondopaminergic targets for motor features of Parkinson’s disease: review of recent trials. Mov Disord. 2013;28(2):131-144. 3. Data on file. Kyowa Kirin Pharmaceutical Development, Inc., Princeton, NJ.

References: 1. NOURIANZ. Prescribing Information. Kyowa Kirin, Inc; 2020. Accessed April 1, 2021. https://www.nourianzhcp.com/assets/pdf/nourianz-full-prescribing-information.pdf 2. Data on file. Kyowa Kirin Pharmaceutical Development, Inc., Princeton, NJ.

Reference: 1. NOURIANZ. Prescribing Information. Kyowa Kirin, Inc; 2020. Accessed April 1, 2021. https://www.nourianzhcp.com/assets/pdf/nourianz-full-prescribing-information.pdf

Reference: 1. NOURIANZ. Prescribing Information. Kyowa Kirin, Inc; 2020. Accessed April 1, 2021. https://www.nourianzhcp.com/assets/pdf/nourianz-full-prescribing-information.pdf