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

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

(PRNewsfoto/Neurocrine Biosciences, Inc.)

Neurocrine Biosciences, the leading neuroscience-focused company in the treatment of DT, will present the results of a post-hoc analysis of the 48-week open-label KINECT 4 study of INGREZZA evaluating treatment response patterns (poster no. ° 75; sustained response to treatment with long-term Valbenazine in patients with tardive dyskinesia). The analysis, which included people who completed KINECT 4 treatment (n=103), found that the proportion of patients meeting stringent response criteria increased over time:

  • The proportion of participants who achieved ≥50% improvement on the Abnormal Involuntary Movement Scale (AIMS) from baseline increased from Week 8 to Week 48 (39% [n=40] at 86 percent [n=89] participants, respectively).

  • Of the 40 participants (39%) with an AIMS response ≥50% at week 8, 95% (38 participants) also reached this threshold at week 48, demonstrating a sustained response.

  • An increase in the proportion of participants who achieved the rigorous 70% or greater improvement in AIMS from baseline increased from Week 8 to Week 48 (17% [n=18] at 52 percent [n=54] participants, respectively).

  • Rates of participants reaching the defined global response threshold (assessment of “much improved” or “much improved”) increased from week 8 to week 48, from 50% to 92% for clinical global impression of change – tardive dyskinesia (CGI-TD) and 53% to 88% for the patient’s global impression of change (PGIC), respectively.

“TD can disrupt many aspects of daily life, and proper assessment, diagnosis, and ongoing symptom management are critically important,” said Eiry W. Roberts, MD, chief medical officer at Neurocrine Biosciences. “These data demonstrate that a large majority of participants taking INGREZZA achieved substantial and sustained improvement in DT throughout the study, and the proportion of patients achieving symptom relief increased with continued treatment over time. time.”

The most common treatment-emergent adverse events (TEAEs) reported in the KINECT 4 study (≥5% of all INGREZZA-treated patients after week 4) were urinary tract infections (8.5%) and top (5.2%).

Additional presentations include:

  • Healthcare Provider Perspectives on Benztropine Use in Medication-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 analyzes of two long-term studies of valbenazine (poster #7)

  • Anticholinergics should not be used to treat tardive dyskinesia: insights from an expert panel of healthcare professionals in psychiatry and neurology (poster 36)

Full abstracts presented by Neurocrine Biosciences at 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 characterized by uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts, which can be disruptive and negatively impact patients. The condition is associated with taking certain types of mental health medications (such as 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, as well as certain medications to treat stomach upset, nausea, and vomiting are associated with the DT. In patients with DD, these treatments are thought to lead to irregular dopamine signaling in a region of the brain that controls movement. Symptoms of TD can be severe and are often persistent and irreversible. TD is estimated to affect approximately 600,000 people in the United States

About INGREZZA® (valbenazine) Capsules
INGREZZA, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is an FDA-cleared 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 bodies. rooms.

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 brain protein that conditions neurotransmitters, such as dopamine, for transport and release into presynaptic neurons. INGREZZA, developed by Neurocrine Biosciences, is novel in that it selectively inhibits VMAT2 without appreciable binding affinity for VMAT1, dopamine (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. Additionally, INGREZZA can be taken for the treatment of tardive dyskinesia as one capsule once daily 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 of the face, tongue or other parts of the body 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 can cause serious side effects, including:

  • Drowsiness (drowsiness). Do not drive, use heavy machinery, or do other dangerous activities until you know how INGREZZA affects you.

  • Heart rhythm disorders (prolongation of the QT interval). INGREZZA can cause a heart problem called QT prolongation.

  • Symptoms of QT prolongation may include:

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

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

Before taking INGREZZA, tell your healthcare professional about all your medical conditions, including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breast-feeding or planning to breast-feed.

Tell your healthcare professional about all medications you are taking, including prescription and over-the-counter medications, vitamins and herbal supplements.

The most common side effect of INGREZZA is drowsiness (drowsiness). Other side effects include balance disorders (problems with balance, dizziness) or increased risk of falls, headaches, feeling restless, dry mouth, constipation and blurred vision.

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

About Neurocrine Biosciences
Neurocrine Biosciences is a neuroscience-driven biopharmaceutical company with a simple goal: to alleviate the suffering of people with high needs, but few options. We are committed to discovering and developing life-changing treatments for patients with undertreated 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 more than a dozen mid- to late-stage clinical programs in multiple therapeutic areas. For three decades, we have applied our unique knowledge of neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly seek out 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 of INGREZZA and the value INGREZZA may bring to patients. Among the factors that could cause actual results to differ materially from those set forth in the forward-looking statements are: the risks and uncertainties associated with the commercialization of INGREZZA; risks that clinical trial activities may not be predictive of actual results or subsequent clinical trial results; the risks that INGREZZA may be prevented from being marketed by the proprietary rights of third parties, or have unintended side effects or adverse reactions; risks and uncertainties related to competing products and technological developments that may limit demand for INGREZZA; risks associated with our reliance on third parties for development and manufacturing activities related to INGREZZA and our product candidates, and our ability to manage such third parties; risks that the FDA or other regulatory authorities make adverse decisions regarding our products or product candidates; the risks that our products and/or product candidates may be prevented from commercialization by the proprietary or regulatory rights of third parties, or that they may experience unintended side effects, adverse reactions or incidents of misuse; risks associated with potential generic entrants for our products; the risks and uncertainties associated with the magnitude and duration of the COVID-19 pandemic and the 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.

©2022 Neurocrine Biosciences, Inc. All rights reserved.

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SOURCE Neurocrine Biosciences, Inc.

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