VMAT1

SAN DIEGO, Nov. 2, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced interim results from the ongoing open-label KINECT®-HD2 study about INGREZZA® (valbenazine) capsules when used for the long-term treatment of adults with chorea associated with Huntington's disease (HD). Interim data suggest one-capsule, once-daily INGREZZA improved chorea at the first evaluation at Week 2 with sustained efficacy through Week 50. These data will be presented at the 30th Annual Meeting of the Huntington Study Group on November 2–4 in Phoenix. "These interim data provide insight on the clinically meaningful and sustained improvements participants are experiencing with INGREZZA for the treatment of chorea," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences®. "We look forward to analyzing additional data as they become available." KINECT-HD2 includes adults with genetically confirmed motor-manifest HD (n=127), most of whom (n=98) completed KINECT-HD, a Phase 3, randomized, double-blind, placebo-controlled study. Both studies were conducted in collaboration with the Huntington Study Group (HSG) and contributed to the recent U.S. Food and Drug Administration approval of INGREZZA for chorea associated with HD. Concomitant antipsychotic use is also being explored in the open-label study. The current interim results from KINECT-HD2 (Sustained Improvements With Once-Daily Valbenazine in Chorea Associated With Huntington's Disease: Interim Results From a Long-Term Open-Label Study, Poster # 64) suggest that INGREZZA improved chorea at the first evaluation (Week 2) when participants were taking the lowest dose of 40 mg, with efficacy sustained through Week 50 at ≤ 80 mg (Figure 1). More than half of participants (60.9 percent) and investigators (58.9 percent) rated symptoms as "much improved" or "very much improved" at Week 6, and about three-quarters of participants (74.2 percent) and investigators (76.9 percent) rated symptoms as "much improved" or "very much improved" by Week 50. The most common treatment-emergent adverse events at the time of the analysis were consistent with those observed in KINECT-HD, including falls (30.4 percent), fatigue (24.0 percent) and somnolence (24.0 percent). Neurocrine Biosciences will also present new data from KINECT-HD (A Wearable Movement Sensor Substudy of KINECT-HD, a Phase 3 Trial of Valbenazine for the Treatment of Chorea Associated With Huntington's Disease, Poster #65), which was the first Phase 3 clinical trial to include a wearable movement sensor substudy. Significant improvements in truncal chorea and gait asymmetry measures were seen from baseline to maintenance following the Week 10 visit in the INGREZZA-treated group (P < 0.05) compared to placebo. These findings support how digital measurements can be used to detect meaningful symptom changes in individuals with HD to improve clinical research and care. Additional HD chorea presentations at the 30th Annual Meeting of the HSG include: The Huntington's Disease Health Index (HD-HI): Measuring Changes in Disease Burden in Response to Valbenazine During the KINECT®-HD Trial (Poster #66) A Minimal Clinically Important Difference for UHDRS® Total Maximal Chorea Score as a Measure of Chorea Severity in Huntington's Disease (Poster #63) Indirect Treatment Comparison of Valbenazine With Deutetrabenazine for Improvement in Total Maximal Chorea Score in Huntington's Disease (Poster #62) The full abstracts can be accessed on the Journal of Huntington's Disease website. 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 KINECT®-HD KINECT®-HD was a Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of valbenazine as a once-daily treatment to reduce chorea associated with Huntington's disease (HD) and evaluate the safety and tolerability of valbenazine in patients with HD. The study enrolled 128 adults 18 to 75 years of age who were diagnosed with motor-manifest HD and who had sufficient chorea symptoms to meet study protocol criteria. KINECT-HD used the Unified Huntington's Disease Rating Scale (UHDRS®) Total Maximal Chorea (TMC) score as the primary efficacy endpoint. The secondary endpoints included Clinical Global Impression of Change (CGI-C) response status and Patient Global Impression of Change (PGI-C) response status for valbenazine treatment. Treatment with valbenazine resulted in a placebo-adjusted mean reduction in the TMC score of 3.2 units (P < 0.0001), indicating a substantial improvement in chorea. Secondary endpoints of CGI-C response status and PGI-C response status were also statistically significant and supported the improvements in TMC score that were seen over the 12-week study period. Treatment-emergent adverse events in this study were generally consistent with the known safety pro valbenazine. The most common adverse reactions in patients with HD included somnolence and sedation, urticaria, rash and insomnia. View the complete study results from the Phase 3 KINECT-HD study published in The Lancet Neurology online edition. For more information on the KINECT-HD study, please visit HuntingtonStudyGroup.org. About KINECT®-HD2 KINECT®-HD2 is an ongoing open-label study to evaluate the long-term safety and tolerability, as well as the maintenance of effects, of INGREZZA in patients with chorea associated with Huntington's disease (HD). The 156-week study has enrolled more than 150 adults 18 to 75 years of age who have been diagnosed with motor-manifest HD and who have sufficient chorea symptoms to meet study protocol criteria. Concomitant antipsychotic use is allowed in the study. For more information on the KINECT-HD2 study, please visit HuntingtonStudyGroup.org or ClinicalTrials.gov. About Huntington Study Group / HSG Clinical Research, Inc. The Huntington Study Group (HSG), a not-for-profit organization founded in 1993 in Rochester, NY, and its wholly owned subsidiary, HSG Clinical Research, Inc., designs and conducts clinical trials through the world's first and largest collaborative network with thousands of members at more than 130 HSG credentialed research sites worldwide. HSG collaborated with the respective study sponsors to complete the three pivotal clinical trials that led to the only FDA-approved medications for Huntington's disease associated chorea. The organization is dedicated to improving the lives of people impacted by Huntington's disease through research, education, and collaboration. For more information, visit . 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 is a prescription medicine 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 does not cure the cause of involuntary movements, and it does not treat other symptoms of Huntington's disease, such as problems with thinking or emotions. 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: are allergic to valbenazine, or any of the ingredients in INGREZZA. INGREZZA may cause serious side effects, including: Sudden swelling from an allergic reaction (angioedema). Sudden swelling has happened after the first dose or after many doses of INGREZZA. Signs and symptoms of angioedema include: swelling of your face, lips, throat, and other areas of your skin, difficulty swallowing or breathing, and raised, red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Go to the nearest emergency room right away if you develop these signs and symptoms. Your healthcare provider should stop your treatment with INGREZZA. 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, dizziness or fainting, or shortness of breath. Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you 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, very fast or uneven heartbeat, or increased sweating. 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. 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 or call 1-800-FDA-1088. Please see INGREZZA full Prescribing Information, including Boxed Warning. About Neurocrine Biosciences 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, X (formerly Twitter) and Facebook. (*in collaboration with AbbVie) NEUROCRINE, NEUROCRINE BIOSCIENCES, the Neurocrine logo, INGREZZA, the INGREZZA logo and KINECT 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 for the treatment of chorea associated with Huntington's disease (HD), and the value INGREZZA for the treatment of chorea associated with HD brings to patients. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements include: risks and uncertainties associated with Neurocrine Biosciences' business and finances in general, as well as risks and uncertainties associated with the commercialization of INGREZZA for the treatment of chorea associated with HD; whether INGREZZA for the treatment of chorea associated with HD receives adequate reimbursement from third-party payors; the degree and pace of market uptake of INGREZZA for the treatment of chorea associated with HD; risks and uncertainties relating to competitive products and technological changes that may limit demand for INGREZZA for the treatment of chorea associated with HD; risks associated with the Company's dependence on third parties for development and manufacturing activities related to INGREZZA for the treatment of chorea associated with HD, and the ability of the Company to manage these third parties; risks that additional regulatory submissions for INGREZZA for the treatment of chorea associated with HD 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 for the treatment of chorea associated with HD; risks that post-approval INGREZZA for the treatment of chorea associated with HD commitments or requirements may be delayed; risks that INGREZZA for the treatment of chorea associated with HD 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 for the treatment of chorea associated with HD; 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, 2023. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof. ©2023 Neurocrine Biosciences, Inc. All Rights Reserved. View original content to download multimedia: SOURCE Neurocrine Biosciences, Inc. Company Codes: NASDAQ-NMS:NBIX

Prescription Drug User Fee Act (PDUFA) Target Action Date Set for April 30, 2024 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 Approved Uses 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). involuntary movements (chorea) of Huntington's disease. INGREZZA does not cure the cause of involuntary movements, and it does not treat other symptoms of Huntington's disease, such as problems with thinking or emotions. 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: are allergic to valbenazine, or any of the ingredients in INGREZZA. INGREZZA may cause serious side effects, including: Sudden swelling from an allergic reaction (angioedema). Sudden swelling has happened after the first dose or after many doses of INGREZZA. Signs and symptoms of angioedema include: swelling of your face, lips, throat, and other areas of your skin, difficulty swallowing or breathing, and raised, red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Go to the nearest emergency room right away if you develop these signs and symptoms. Your healthcare provider should stop your treatment with INGREZZA. 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, dizziness or fainting, or shortness of breath. Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you 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, very fast or uneven heartbeat, or increased sweating. 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. 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 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. 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 oral granules and the value INGREZZA oral granules 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 that INGREZZA oral granules may not obtain regulatory approval, or that the U.S. Food and Drug Administration or regulatory authorities outside the U.S. may make adverse decisions regarding INGREZZA oral granules; risks and uncertainties associated with the commercialization of INGREZZA oral granules; risks that clinical trial activities may not be predictive of real-world results or of results in subsequent clinical trials; risks that INGREZZA oral granules 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 oral granules; risks associated with our dependence on third parties for development and manufacturing activities related to INGREZZA oral granules 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; 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, 2023. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof. Company Codes: NASDAQ-NMS:NBIX

SAN DIEGO, Aug. 29, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today presented findings from a data analysis of KINECT®-4 demonstrating a comparable pattern of improvement over time of clinician-rated tardive dyskinesia (TD) severity and awareness/distress as measured by the Abnormal Involuntary Movement Scale (AIMS) and patient-reported TD impact as measured by the Trajectories of Tardive Dyskinesia Impact Scale (TDIS). The data (Poster #657) was presented at the MDS International Congress of Parkinson's Disease and Movement Disorders® in Copenhagen, Denmark. ​ The data analysis evaluated the use of INGREZZA for the treatment of TD among all 167 patients with either schizophrenia or mood disorders enrolled over the course of the Phase 3, open-label, long-term study. On average, the analysis suggested that clinician-rated TD severity as measured by AIMS and patient-reported assessment of the physical, social and emotional impact of TD as measured by TDIS decreased with one-capsule, once-daily INGREZZA treatment over the course of the 48-week study. Researchers concluded that the use of AIMS and TDIS in evaluating symptom improvement during treatment may give a more complementary understanding regarding the patient's TD experience. "The use of AIMS and TDIS provides a more complete perspective on the patient's TD experience," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. "While AIMS is helpful to assess TD severity as perceived by the healthcare provider and to follow the severity of TD over time, TDIS enables us to assess the physical, social and emotional impact of these involuntary movements from the patient perspective. The insight gained from these data also supports the efficacy of treatment with INGREZZA in reducing both HCP-perceived severity and patient-reported impact of TD." The study showed that though AIMS and TDIS measure unique aspects of TD, TDIS demonstrated a comparable pattern of improvement to the AIMS total score, TD severity as measured by AIMS item 8 (AIMS8), incapacitation as measured by AIMS item 9 (AIMS9) and awareness/distress as measured by AIMS item 10 (AIMS10) over the 48-week treatment period. Key results from the analysis demonstrated the following: Mean AIMS total score at baseline was 14.6 and decreased over 48 weeks, with a mean change from baseline of -10.2 (standard deviation [SD]=1.2) for the 40 mg cohort and -11.0 (SD=0.5) for the 80 mg cohort, as assessed by site raters. (n=163) At baseline, TD severity was moderate (AIMS8 mean=3.2) and most patients were aware of TD with moderate distress (AIMS10 mean=2.7). TD severity and distress decreased, with most patients scored with minimal severity (AIMS8=1) and as aware/no distress at 48 weeks (AIMS10=1). (n=167) Mean TDIS scores decreased from 16.5 at baseline to 6.0 at Week 48, indicating TD had a moderate impact on activity by the end of the INGREZZA treatment period. (n=167) Additional presentation at the MDS International Congress of Parkinson's Disease and Movement Disorders® includes: Crushing Valbenazine Capsule Contents for Potential Addition to Soft Foods or Administration via G Tube (poster #9) About the KINECT-4 Phase 3 Study KINECT®-4 is a Phase 3, open-label study, in which 163 participants with moderate to severe TD and underlying schizophrenia, schizoaffective disorder or mood disorder (including bipolar disorder or major depressive disorder) received 48 weeks of open-label treatment with once-daily INGREZZA (40 mg or 80 mg capsules) followed by a four-week washout. Dosing was initiated at 40 mg/day in all participants, with escalation to 80 mg/day at Week 4 based on effectiveness and tolerability. Dose reduction to 40 mg was allowed in participants who could not tolerate the 80 mg dose. Patients were discontinued if the new dose was not tolerated. Participants experienced TD improvements during long-term treatment as demonstrated by mean change from baseline to Week 48 in AIMS total score (sum of items 1-7, evaluated by site raters) with INGREZZA 40 mg/day (-10.2) or 80 mg/day (-11.0). Consistent with previous studies, INGREZZA was generally well tolerated. After Week 4, treatment emergent adverse events (TEAEs) that occurred in ≥ 5 percent of all participants (combined dose groups) were urinary tract infection (8.5 percent) and headache (5.2 percent). Changes from baseline in psychiatric stability, vital signs, electrocardiogram parameters and laboratory test values were generally small and not clinically significant. 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 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 United States. 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 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 for the treatment of tardive dyskinesia 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 is a prescription medicine 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 does not cure the cause of involuntary movements, and it does not treat other symptoms of Huntington's disease, such as problems with thinking or emotions. 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: are allergic to valbenazine, or any of the ingredients in INGREZZA. INGREZZA may cause serious side effects, including: Sudden swelling from an allergic reaction (angioedema). Sudden swelling has happened after the first dose or after many doses of INGREZZA. Signs and symptoms of angioedema include: swelling of your face, lips, throat, and other areas of your skin, difficulty swallowing or breathing, and raised, red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Go to the nearest emergency room right away if you develop these signs and symptoms. Your healthcare provider should stop your treatment with INGREZZA. 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, dizziness or fainting, or shortness of breath. Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you 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, very fast or uneven heartbeat, or increased sweating. 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. 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 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, KINECT 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; 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, 2023. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof. ©2023 Neurocrine Biosciences, Inc. All Rights Reserved. ​ View original content to download multimedia: SOURCE Neurocrine Biosciences, Inc. Company Codes: NASDAQ-NMS:NBIX