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SAN DIEGO , Sept. 14, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX ) today announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for INGREZZA ® (valbenazine) oral granules, a new sprinkle formulation of INGREZZA ® (valbenazine) capsules for oral administration. The agency set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024 .
The INGREZZA oral granules capsules (40 mg, 60 mg and 80 mg) are intended to be opened for sprinkling on soft foods prior to administration. The NDA filing included chemistry, manufacturing, and controls (CMC) information and data demonstrating the bioequivalence and tolerability of the INGREZZA oral granule sprinkle capsules compared to the currently approved INGREZZA capsules.
"Patients with tardive dyskinesia or chorea associated with Huntington's disease can experience dysphagia that can impact their ability to swallow capsules," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. "We developed this potential new formulation of INGREZZA as an alternative administration option for those patients who have difficulty swallowing or simply prefer not to take whole capsules."
INGREZZA is currently available as the only one-capsule, once-daily treatment option with no complex titration for adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease. It 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.
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
INGREZZA ® (valbenazine) capsules is a prescription medicine used to treat adults with:
It is not known if INGREZZA is safe and effective in children.
IMPORTANT SAFETY INFORMATION
VMAT2 inhibitors, including INGREZZA, 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 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 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 if you:
INGREZZA may cause serious side effects, including:
Before taking INGREZZA, 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.
Sleepiness (sedation) is a common side effect with INGREZZA. While taking INGREZZA, do not drive a car or operate dangerous machinery until you know how INGREZZA affects you. Drinking alcohol and taking other drugs that may also cause sleepiness while you are taking INGREZZA may increase any sleepiness caused by INGREZZA.
The most common side effect of INGREZZA in people with tardive dyskinesia is sleepiness (somnolence).
The most common side effects of INGREZZA in people with Huntington's disease are sleepiness (somnolence), allergic itching, rash, and trouble getting to sleep or staying asleep.
These are not all of the possible side effects of INGREZZA. 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 .
Please see INGREZZA full Prescribing Information , including Boxed Warning.
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, Parkinson'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 , Twitter and Facebook . (* in collaboration with AbbVie )
NEUROCRINE, the Neurocrine logos, and INGREZZA are registered trademarks of Neurocrine Biosciences, Inc.
SOURCE Neurocrine Biosciences, Inc.