Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced data from pooled analyses demonstrating the long-term benefit of the once-daily 40 mg dose of INGREZZA® (valbenazine) capsules in reducing abnormal movements in adults with tardive dyskinesia (TD), a potentially irreversible and often persistent involuntary movement disorder.
| SAN DIEGO, Oct. 4, 2019 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced data from pooled analyses demonstrating the long-term benefit of the once-daily 40 mg dose of INGREZZA® (valbenazine) capsules in reducing abnormal movements in adults with tardive dyskinesia (TD), a potentially irreversible and often persistent involuntary movement disorder. The analyses of pooled data from multiple long-term studies of the 40 mg dose showed that 53.7% of patients taking 40 mg of INGREZZA achieved an Abnormal Involuntary Movement Scale (AIMS) response (≥ 50% improvement from baseline) after 48 weeks of treatment. INGREZZA is available in two doses, 40 mg and 80 mg. Additionally, an analysis of the pivotal Phase III KINECT 3 data demonstrated that 50% of patients achieved an early response after two weeks of INGREZZA treatment (40 mg or 80 mg). Data also showed that meaningful long-term reductions in TD were achieved regardless of whether patients responded after two weeks. These long-term INGREZZA data were presented today at the 2019 Annual Psych Congress in San Diego.
“Tardive dyskinesia is a persistent and often irreversible movement disorder, and it can look and feel different from one patient to another, with each patient having distinct treatment needs,” said Craig Chepke, M.D., Adjunct Assistant Professor of Psychiatry, University of North Carolina School of Medicine. “Long-term data from the pooled analyses are important as they show that the 40 mg dose of INGREZZA is effective in reducing the troublesome movements of tardive dyskinesia in over 50% of patients. Many patients feel embarrassed, endure social isolation and experience even greater stigma associated with their existing mental illness, so having two effective dosing options of INGREZZA gives healthcare providers a choice in what will work best to manage the burdensome and disruptive involuntary movements associated with tardive dyskinesia.” INGREZZA is the first U.S. Food and Drug Administration (FDA) approved treatment for adults with TD, a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts. The abnormal and involuntary movements of TD can impact patients socially, emotionally and physically, causing patients to feel embarrassed or judged by others or withdraw from society and isolate themselves. “The analyses of pooled data continue to support the growing body of evidence that INGREZZA is an effective treatment for the long-term management of tardive dyskinesia,” said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. “It is important to choose the best dosing option of INGREZZA and continue treatment to achieve long-term outcomes as tardive dyskinesia varies from patient to patient as well as their treatment response.” Data from pooled analyses of long-term clinical studies, KINECT 3 and KINECT 4, showed that 53.7% of patients taking 40 mg of INGREZZA (n=54) achieved an AIMS response (≥ 50% improvement from baseline) after 48 weeks of treatment and 65.5% of patients (n=55) demonstrated a Clinical Global Impression of Change-Tardive Dyskinesia (CGI-TD) response (defined as “very much improved” or “much improved”). Additionally, dose reductions from 80 mg to 40 mg did not appear to compromise the long-term benefit of INGREZZA. Neurocrine Biosciences also presented a post-hoc analysis of KINECT 3, the pivotal Phase III study, indicating that both the 40 mg and 80 mg doses of INGREZZA improved TD as early as two weeks in adults with TD, as measured by global clinician and patient scales. Results showed that 50% of patients (n=143) reached an early response threshold by patient-reported assessment (Patient Global Impression of Change [PGIC]; score ≤ 3 at Week 2), while 43% achieved an early response by clinician judgement (CGI-TD; score ≤ 3 at Week 2). Long-term reductions in TD symptom severity were meaningful regardless of early response as indicated by both PGIC and CGI-TD improvement. In the studies, INGREZZA was generally well tolerated with no new safety concerns observed, and patients had no notable worsening of psychiatric symptoms. The most common adverse reactions (≥5% and twice the rate of placebo) during the 6-week double-blind, placebo-controlled phase was somnolence. About the KINECT 3 Phase III Study The study met its primary endpoint of change-from-baseline in AIMS at week six in the 80 mg once-daily dosing group compared to placebo as assessed by expert central blinded video raters. The mean change from baseline to week six in the AIMS rating was -3.2 for the 80 mg once-daily group as compared to -0.1 in the placebo group (p>0.0001). Sustained TD improvements were seen with INGREZZA 40 mg and 80 mg through week 48. INGREZZA was generally well tolerated throughout 48 weeks of treatment. The most common adverse reactions (≥5% and twice the rate of placebo) during the 6-week double-blind, placebo-controlled phase was somnolence with the frequency of adverse events being similar among all treatment groups. Treatment emergent adverse events (TEAEs) were consistent with those of prior studies. There were no drug-drug interactions identified in participants who were utilizing a wide range of psychotropic and other concomitant medications and participants generally remained psychiatrically stable throughout the study. About the KINECT 4 Phase III Study 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, TEAEs that occurred in ≥5% of all participants (combined dose groups) were urinary tract infection (8.5%) and headache (5.2%). Change from baseline in psychiatric stability, vital signs, electrocardiogram parameters, and laboratory test values were generally small and not clinically significant. About Tardive Dyskinesia (TD) About INGREZZA® (valbenazine) Capsules 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 in Neurocrine’s laboratories, 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 psychiatric medications such as antipsychotics or antidepressants. Important Safety Information Contraindications Warnings & Precautions QT Prolongation Parkinsonism Adverse Reactions 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 at www.INGREZZA.com/PI. About Neurocrine Biosciences, Inc. Forward-Looking Statements
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Company Codes: NASDAQ-NMS:NBIX |
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