Approximately 90% of patients receiving 40 mg (90.0%) or 80 mg (89.2%) of INGREZZA achieved ≥50% improvement from baseline as measured by the Abnormal Involuntary Movement Scale (AIMS) total score at 48 weeks of treatment and 89-95% of patients achieved a Clinical Global Impression of Change-TD (CGI-TD) or Patient Global Impression of Change (PGIC) response of "much improved" or "very much improved." INGREZZA was generally well tolerated with no new safety concerns observed, and patients had no notable worsening of psychiatric symptoms.
"Data from this open-label study, which may be more reflective of actual clinical practice, provide clinicians with a better understanding of how INGREZZA can reduce the symptoms of tardive dyskinesia based on both the clinician's and patient's assessment of the patient's symptoms, tolerability and response," said
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.
"Approximately 90% of patients treated with INGREZZA in the long-term KINECT 4 study reported that their involuntary movements were reduced by 50% or more, further demonstrating that treatment with INGREZZA can provide patients with much-needed relief from the debilitating symptoms of tardive dyskinesia that can also impact their social, emotional and physical well-being," said Eiry W. Roberts, M.D., Chief Medical Officer of
Of the 163 patients included for analysis, 107 (65.6%) were escalated to the 80 mg/day dose at the week 4 escalation visit. Based on clinician judgment, 45 (27.6%) were maintained on the 40 mg/day dose for tolerability reasons or because they were already experiencing an adequate treatment response. In the group of patients that required a dose reduction from 80 to 40 mg/day (n=11), efficacy did not appear to be compromised in this small subgroup of patients.
The most common treatment-emergent adverse events (TEAE) reported in ≥5% of all INGREZZA treated patients after week 4 were urinary tract infection (8.5%) and headache (5.2%).
About the KINECT 4 Phase III Study
KINECT 4 is a Phase III, 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 4-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.
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)
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 caused by prolonged use of treatments that block dopamine receptors in the brain, such as antipsychotics commonly prescribed to treat mental illnesses such as schizophrenia, bipolar disorder and depression and certain anti-nausea medications. 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 at least 500,000 people in the U.S.
About INGREZZA® (valbenazine) Capsules
INGREZZA, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is the first
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
INGREZZA is contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported.
Warnings & Precautions
INGREZZA can cause somnolence. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA.
INGREZZA may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.
INGREZZA may cause parkinsonism in patients with tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. Reduce the dose or discontinue INGREZZA treatment in patients who develop clinically significant parkinson-like signs or symptoms.
The most common adverse reaction (≥5% and twice the rate of placebo) is somnolence. Other adverse reactions (≥2% and >placebo) include: anticholinergic effects, balance disorders/falls, headache, akathisia, vomiting, nausea, and arthralgia.
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-
Please see INGREZZA full Prescribing Information at www.INGREZZA.com/PI.
About Neurocrine Biosciences
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 related to the benefits to be derived from INGREZZA and the continued success of the launch of INGREZZA. 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 and uncertainties relating to factors that may limit demand for INGREZZA; risks associated with the Company's dependence on third parties for development and manufacturing activities related to INGREZZA, and the ability of the Company to manage these third parties; risks that the
- Marder, S. et al. A Phase 3, 1-Year, Open-Label Trial of Valbenazine in Adults With Tardive Dyskinesia. J. Clin. Psychopharmacol., 39 (2019), pp 620-627. doi: 10.1097/JCP.0000000000001111
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