SAN
DIEGO, April 30, 2024 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food
and Drug Administration has approved INGREZZA® SPRINKLE
(valbenazine) capsules, a new oral granules formulation of
INGREZZA® (valbenazine) capsules prescribed for the
treatment of adults with tardive dyskinesia and chorea associated
with Huntington's disease.1 INGREZZA SPRINKLE provides
an alternative administration option for those who experience
dysphagia or have difficulty swallowing.
Like the original formulation of INGREZZA capsules, INGREZZA
SPRINKLE offers simple dosing that's always one capsule, once daily
with no complex titration.1 INGREZZA is the only
selective vesicular monoamine transporter 2 (VMAT2) inhibitor that
offers three effective dosages (40 mg, 60 mg and 80 mg) that can be
adjusted by the healthcare provider based on patient response and
tolerability.1 INGREZZA SPRINKLE offers the same dosage
strengths, and the contents of the capsules can be easily sprinkled
on soft food for oral administration.
"We developed INGREZZA SPRINKLE to make administration easier
for patients who have difficulty swallowing or prefer not to take a
capsule," said Eiry W. Roberts, M.D., Chief Medical Officer at
Neurocrine Biosciences. "We are pleased to offer the proven
efficacy of INGREZZA in reducing uncontrollable movements in a new
formulation."
Taking pills can be difficult for people experiencing chorea
associated with Huntington's disease (HD) in addition to those
living with tardive dyskinesia (TD)2:
- In a survey of patients with chorea associated with HD
and their caregivers (n = 78), 62% reported difficulty swallowing
because of their involuntary movements. ‡,†
- In a survey of patients with TD experiencing
moderate-to-severe involuntary movement symptoms (n = 250), 37%
reported that their movements impacted their ability to eat and
drink.*,§
The U.S. Food and Drug Administration (FDA) approval was based
on chemistry, manufacturing, and controls information and data
demonstrating the bioequivalence and tolerability of INGREZZA
SPRINKLE compared to INGREZZA capsules.
About Tardive Dyskinesia (TD)
Tardive dyskinesia (TD)
is a movement disorder that is characterized by uncontrollable,
abnormal and repetitive movements of the face, torso and/or other
body parts, which may be disruptive and negatively impact patients.
The condition is associated with taking certain kinds of mental
health medicines (antipsychotics) that help control dopamine
receptors in the brain. Taking antipsychotics commonly prescribed
to treat mental illnesses such as major depressive disorder,
bipolar disorder, schizophrenia and schizoaffective disorder and
other prescription medicines (metoclopramide and prochlorperazine)
used to treat gastrointestinal disorders are associated with TD. In
patients with TD, these treatments are thought to result in
irregular dopamine signaling in a region of the brain that controls
movement. The symptoms of TD can be severe and are often persistent
and irreversible. TD is estimated to affect approximately 600,000
people in the U.S.
About Chorea Associated with Huntington's Disease
(HD)
Huntington's disease (HD) is a hereditary progressive
neurodegenerative disorder in which the loss of certain neurons
within the brain causes motor, cognitive and psychiatric symptoms.
Symptoms generally appear between the ages of 30 and 50 years and
worsen over a 10- to 25-year period. Most people with HD experience
chorea, an abnormal involuntary movement disorder, characterized by
irregular and unpredictable movements. Chorea can affect various
body parts and interfere with motor coordination, gait, swallowing
and speech. HD is estimated to affect approximately 41,000 adults
in the U.S., with more than 200,000 at risk of inheriting the
disease.
About INGREZZA® (valbenazine)
Capsules
INGREZZA is the only one-capsule, once-daily
selective vesicular monoamine transporter 2 (VMAT2) inhibitor
approved by the U.S. Food and Drug Administration for the treatment
of adults with tardive dyskinesia and the treatment of chorea
associated with Huntington's disease (HD).
INGREZZA, developed by Neurocrine Biosciences, selectively
inhibits VMAT2 with no appreciable binding affinity for VMAT1,
dopaminergic (including D2), serotonergic, adrenergic,
histaminergic or muscarinic receptors. While the specific way
INGREZZA works to treat TD and HD chorea is not fully understood,
INGREZZA selectively targets VMAT2 to inhibit the release of
dopamine, a chemical in the brain that helps control movement.
INGREZZA is believed to reduce extra dopamine signaling, which may
lead to fewer uncontrollable movements. Additionally, INGREZZA can
be taken as one capsule, once daily together with most psychiatric
medications such as antipsychotics or antidepressants. INGREZZA
dosages approved for use are 40 mg, 60 mg and 80 mg capsules.
INGREZZA is not approved in any other dosage form.
Important Information
Approved Uses
INGREZZA® (valbenazine) capsules or
INGREZZA® SPRINKLE (valbenazine) capsules are
prescription medicines used to treat adults with:
- movements in the face, tongue, or other body parts that cannot
be controlled (tardive dyskinesia).
- involuntary movements (chorea) of Huntington's disease.
INGREZZA or INGREZZA SPRINKLE do not cure the cause of involuntary
movements, and do not treat other symptoms of Huntington's disease,
such as problems with thinking or emotions.
It is not known if INGREZZA or INGREZZA SPRINKLE is safe and
effective in children.
IMPORTANT SAFETY INFORMATION
VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE,
can cause serious side effects in people with Huntington's disease,
including: depression, suicidal thoughts, or suicidal actions.
Tell your healthcare provider before you start taking INGREZZA or
INGREZZA SPRINKLE if you have Huntington's disease and are
depressed (have untreated depression or depression that is not well
controlled by medicine) or have suicidal thoughts. Pay close
attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or feelings. This is especially important when
INGREZZA or INGREZZA SPRINKLE is started and when the dose is
changed. Call your healthcare provider right away if you become
depressed, have unusual changes in mood or behavior, or have
thoughts of hurting yourself.
Do not take INGREZZA or INGREZZA SPRINKLE if you:
- are allergic to valbenazine, or any of the ingredients in
INGREZZA or INGREZZA SPRINKLE.
INGREZZA or INGREZZA SPRINKLE can cause serious side effects,
including:
- Allergic reactions. Allergic reactions, including an
allergic reaction that causes sudden swelling called angioedema can
happen after taking the first dose or after many doses of INGREZZA
or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and
angioedema include: trouble breathing or shortness of breath,
swelling of your face, lips, eyelids, tongue, or throat, or other
areas of your skin, trouble with swallowing, or rash, including
raised, itchy red areas on your skin (hives). Swelling in the
throat can be life-threatening and can lead to death. Stop taking
INGREZZA or INGREZZA SPRINKLE and go to the nearest emergency room
right away if you develop these signs and symptoms of allergic
reactions and angioedema.
- Sleepiness and tiredness that could cause slow reaction
times (somnolence and sedation). Do not drive a car or operate
dangerous machinery until you know how INGREZZA or INGREZZA
SPRINKLE affects you. Drinking alcohol and taking other medicines
may also cause sleepiness during treatment with INGREZZA or
INGREZZA SPRINKLE.
- Heart rhythm problems (QT prolongation). INGREZZA or
INGREZZA SPRINKLE may cause a heart rhythm problem known as QT
prolongation. You have a higher chance of getting QT prolongation
if you also take certain other medicines during treatment with
INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right
away if you develop any signs or symptoms of QT prolongation,
including: fast, slow, or irregular heartbeat (heart palpitations),
shortness of breath, dizziness or lightheadedness, or fainting or
feeling like you are going to faint.
- Neuroleptic Malignant Syndrome (NMS). NMS is a serious
condition that can lead to death. Call a healthcare provider right
away or go to the nearest emergency room if you develop these
symptoms and they do not have another obvious cause: high fever,
stiff muscles, problems thinking, irregular pulse or blood
pressure, increased sweating, or very fast or uneven
heartbeat.
- Parkinson-like symptoms. Symptoms include: body
stiffness, drooling, trouble moving or walking, trouble keeping
your balance, shaking (tremors), or falls.
Before taking INGREZZA or INGREZZA SPRINKLE, tell your
healthcare provider about all of your medical conditions including
if you: have liver or heart problems, are pregnant or plan to
become pregnant, or are breastfeeding or plan to
breastfeed.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Make sure you tell all
of your healthcare providers that you are taking INGREZZA or
INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with
certain other medicines may cause serious side effects. Especially
tell your healthcare provider if you: take digoxin or take or have
taken a monoamine oxidase inhibitor (MAOI) medicine. You should not
take INGREZZA or INGREZZA SPRINKLE if you are taking, or have
stopped taking, a MAOI within the last 14 days.
The most common side effect of INGREZZA or INGREZZA SPRINKLE
in people with tardive
dyskinesia are sleepiness and tiredness.
The most common side effects of INGREZZA or INGREZZA SPRINKLE
in people with chorea associated with Huntington's disease
include sleepiness and tiredness, raised itchy red areas on
your skin (hives), rash, and trouble getting to sleep or staying
asleep.
These are not all of the possible side effects of INGREZZA or
INGREZZA SPRINKLE. Call your doctor for medical advice about side
effects. You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit MedWatch at
www.fda.gov/medwatch or
call 1-800-FDA-1088.
Dosage Forms and Strengths: INGREZZA is available in 40
mg, 60 mg, and 80 mg capsules. INGREZZA SPRINKLE is available in 40
mg, 60 mg, and 80 mg oral granules in capsules.
Please see full Prescribing
Information, including Boxed Warning, and Medication
Guide.
About Neurocrine Biosciences, Inc.
Neurocrine
Biosciences is a leading neuroscience-focused,
biopharmaceutical company with a simple purpose: to relieve
suffering for people with great needs, but few options. We are
dedicated to discovering and developing life-changing treatments
for patients with under-addressed neurological,
neuroendocrine and neuropsychiatric disorders.
The company's diverse portfolio includes FDA-approved treatments
for tardive dyskinesia, chorea associated with
Huntington's disease, endometriosis* and uterine fibroids*, as well
as a robust pipeline including multiple compounds in mid- to
late-phase clinical development across our core therapeutic areas.
For three decades, we have applied our unique insight into
neuroscience and the interconnections between brain and body
systems to treat complex conditions. We relentlessly pursue
medicines to ease the burden of debilitating diseases and
disorders, because you deserve brave science. For more information,
visit neurocrine.com, and follow the company
on LinkedIn, X (formerly Twitter)
and Facebook. (*in collaboration with
AbbVie)
NEUROCRINE BIOSCIENCES, NEUROCRINE, YOU DESERVE BRAVE SCIENCE
and INGREZZA are registered trademarks of Neurocrine Biosciences,
Inc. The Neurocrine logo is a trademark of Neurocrine Biosciences,
Inc.
Forward-Looking Statements
In addition to historical
facts, this press release contains forward-looking statements that
involve a number of risks and uncertainties. These statements
include, but are not limited to, statements regarding the potential
benefits to be derived from INGREZZA SPRINKLE and the value
INGREZZA SPRINKLE may bring to patients. Among the factors that
could cause actual results to differ materially from those
indicated in the forward-looking statements are: risks and
uncertainties associated with Neurocrine Biosciences' business and
finances in general, as well as risks and uncertainties associated
with the commercialization of INGREZZA SPRINKLE; whether INGREZZA
SPRINKLE receives adequate reimbursement from third-party payors;
the degree and pace of market uptake of INGREZZA SPRINKLE; risks
and uncertainties relating to competitive products and
technological changes that may limit demand for INGREZZA SPRINKLE;
risks associated with the Company's dependence on third parties for
development and manufacturing activities related to INGREZZA
SPRINKLE, and the ability of the Company to manage these third
parties; risks that additional regulatory submissions for INGREZZA
SPRINKLE or other product candidates may not occur or be submitted
in a timely manner; risks that the FDA or other regulatory
authorities may make adverse decisions regarding INGREZZA SPRINKLE;
risks that post-approval INGREZZA SPRINKLE commitments or
requirements may be delayed; risks that INGREZZA SPRINKLE may be
precluded from commercialization by the proprietary rights of third
parties, or have unintended side effects, adverse reactions or
incidents of misuse; risks and uncertainties relating to
competitive products and technological changes that may limit
demand for INGREZZA SPRINKLE; and other risks described in the
Company's periodic reports filed with the Securities and Exchange
Commission, including without limitation the Company's quarterly
report on Form 10-K for the year ended December 31, 2023. Neurocrine Biosciences
disclaims any obligation to update the statements contained in this
press release after the date hereof.
References
- INGREZZA® (valbenazine) capsules (package insert).
San Diego, CA; Neurocrine
Biosciences. 2024.
- Date on file. Neurocrine Biosciences, Inc.
*Tardive Dyskinesia
Patient ATU 2023. Target patients (diagnosed TD or suspected TD), n
= 250.
|
|
§Responses based on
survey questions: "Since first experiencing involuntary movements,
how has your ability to physically perform the following daily
activities been affected, if at all?" and "How would you describe
the severity of your involuntary movements?" Please use a scale of
1 to 5 when 1 means "Not at all affected" and 5 means "Extremely
negatively affected." Results shown include the number of responses
greater than or equal to 3 on the scale.
|
|
‡ Huntington's Disease
Patient and Caregiver ATU 2022. Target patients (patients with
chorea seeing an HCP on a regular basis for management of HD and
their caregivers), n = 78.
|
|
† Responses based on
survey question: "Which, if any, of the following involuntary /
uncontrollable movement symptoms [PATIENT have] [CAREGIVER has] you
ever experienced (or someone else has noticed [PATIENT you]
[CAREGIVER they] experienced)? This includes symptoms that may be
controlled by medication. Please select all that apply."
|
© 2024 Neurocrine Biosciences, Inc. All Rights Reserved.
CP-VBZ-US-3402 04/2024
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SOURCE Neurocrine Biosciences, Inc.