Neurocrine Biosciences Presents INGREZZA® (valbenazine) Data on Sustained Treatment Response at Psych Congress 2022

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Sep 19, 2022, 08:30 ET

SAN DIEGO, Sept. 19, 2022 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that it will present data demonstrating sustained improvements with long-term INGREZZA^® (valbenazine) capsules treatment in adults with tardive dyskinesia (TD) at the Psych Congress 2022 scientific meeting being held September 17-20.

Neurocrine Biosciences, the leading neuroscience-focused company in the treatment of TD, will present findings from a post hoc analysis of the 48-week, open-label KINECT 4 study of INGREZZA evaluating treatment response patterns (Poster #75; Sustained Treatment Response with Long-Term Valbenazine in Patients with Tardive Dyskinesia). The analysis, which included treatment completers of KINECT 4 (n=103), found that the proportion of patients meeting rigorous response criteria increased over time:

The proportion of participants who reached a ≥50 percent Abnormal Involuntary Movement Scale (AIMS) improvement from baseline increased from week 8 to week 48 (39 percent [n=40] to 86 percent [n=89] of participants, respectively).
Of the 40 participants (39 percent) with AIMS ≥50 percent response at week 8, 95 percent (38 participants) also met this threshold at week 48, demonstrating a sustained response.
An increase in proportion of participants that met the rigorous 70 percent or more AIMS improvement from baseline increased from week 8 to week 48 (17 percent [n=18] to 52 percent [n=54] of participants, respectively).
Rates of participants meeting the defined global response threshold (rating of "much improved" or "very much improved") increased from week 8 to week 48, from 50 percent to 92 percent for Clinical Global Impression of Change-Tardive Dyskinesia (CGI-TD) and 53 percent to 88 percent for Patient Global Impression of Change (PGIC), respectively.

"TD can disrupt many aspects of day-to-day life, and adequate assessment, diagnosis, and continued management of symptoms are of key importance," said Eiry W. Roberts, MD, Chief Medical Officer at Neurocrine Biosciences. "These data demonstrate that a vast majority of participants taking INGREZZA obtained substantial and sustained TD improvement throughout the study, and the proportion of patients achieving symptom relief increased with continued treatment over time."

The most common treatment-emergent adverse events (TEAE) reported in KINECT 4 (≥5 percent of all INGREZZA-treated patients after week 4) were urinary tract infection (8.5 percent) and headache (5.2 percent).

Additional presentations include:

Healthcare Provider Perspective of Benztropine Use in Drug-Induced Movement Disorders, Including Tardive Dyskinesia, a 2021-2022 Real-World Survey (Poster #46)
Treatment Success and Psychiatric Stability in Adults with Tardive Dyskinesia: Post Hoc Analyses of Two Long-Term Valbenazine Studies (Poster #7)
Anticholinergics Should Not Be Used to Treat Tardive Dyskinesia: Insights from an Expert Panel of Psychiatry and Neurology Healthcare Professionals (Poster #36)

The full abstracts being presented by Neurocrine Biosciences at the Psych Congress 2022 can be accessed by registering for the meeting (national.psychcongress.com/rates).

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 (like antipsychotics) that help control dopamine receptors in the brain. Taking antipsychotics commonly prescribed to treat mental illnesses such as depression, bipolar disorder, schizophrenia and schizoaffective disorder, and certain medications to treat upset stomach, nausea and vomiting 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 INGREZZA^® (valbenazine) Capsules
INGREZZA, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is an FDA-approved product indicated for the treatment of adults with tardive dyskinesia, a condition associated with uncontrollable, abnormal, and repetitive movements of the face, torso and/or other body parts.

INGREZZA is thought to work by reducing the amount of dopamine released in a region of the brain that controls movement and motor function, helping to regulate nerve signaling in adults with tardive dyskinesia. VMAT2 is a protein in the brain that packages neurotransmitters, such as dopamine, for transport and release in presynaptic neurons. INGREZZA, developed by Neurocrine Biosciences, is novel in that it selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic, or muscarinic receptors. Additionally, INGREZZA can be taken for the treatment of tardive dyskinesia as one capsule, once-daily, together with most psychiatric medications such as antipsychotics or antidepressants.

Important Information

Approved Use

INGREZZA^®(valbenazine) capsules is a prescription medicine used to treat adults with movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia).

It is not known if INGREZZA is safe and effective in children.

Important Safety Information

Do not take INGREZZA if you:

are allergic to valbenazine, or any of the ingredients in INGREZZA.
INGREZZA may cause serious side effects, including:
Sleepiness (somnolence). Do not drive, operate heavy machinery, or do other dangerous activities until you know how INGREZZA affects you.
Heart rhythm problems (QT prolongation). INGREZZA may cause a heart problem known as QT prolongation.
Symptoms of QT prolongation may include:

fast, slow, or irregular heartbeat
shortness of breath
dizziness or fainting

Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you faint.

Abnormal movements (Parkinson-like). Symptoms include: shaking, body stiffness, trouble moving or walking, or keeping your balance.

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.

The most common side effect of INGREZZA is sleepiness (somnolence). Other side effects include changes in balance (balance problems, dizziness) or an increased risk of falls, headache, feelings of restlessness, dry mouth, constipation, and blurred vision.

These are not all of the possible side effects of INGREZZA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see INGREZZA full Product Information.

About Neurocrine Biosciences
Neurocrine Biosciences is a 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, Parkinson's disease, endometriosis* and uterine fibroids*, as well as over a dozen mid- to late-stage clinical programs in multiple 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 logo, and INGREZZA are registered trademarks 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 and the value INGREZZA 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 the commercialization of INGREZZA; risks that clinical trial activities may not be predictive of real-world results or of results in subsequent clinical trials; risks that INGREZZA may be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects or adverse reactions; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA; risks associated with our dependence on third parties for development and manufacturing activities related to INGREZZA and our product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with potential generic entrants for our products; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting global, national, and local economic and financial disruptions; 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-Q for the quarter ended June 30, 2022. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof.

SOURCE Neurocrine Biosciences, Inc.