Tardive dyskinesia is thought to affect at least 500,000 people in the U.S. and is characterized by uncontrollable, abnormal and repetitive movements of the trunk, extremities and/or face. These symptoms are associated with chronic exposure to dopamine receptor blockers such as antipsychotic medications and can be severe, persistent and irreversible. In some cases, they can even interfere with speech, walking, swallowing and breathing.
"The unprecedented results from the Kinect 3 study demonstrate the potential of INGREZZA to fill a significant unmet need in this underserved patient population," said
"There are currently no medications indicated for the treatment of tardive dyskinesia approved by the
Neurocrine has submitted a New Drug Application (NDA) to the
Kinect 3 Study Results
The study met its primary endpoint of change-from-baseline in the Abnormal Involuntary Movement Scale (AIMS) at week six in the 80mg 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 80mg once-daily group as compared to -0.1 in the placebo group (p>0.0001).
In addition, the percentage of participants who achieved an AIMS response (defined in the study as a reduction greater than or equal to 50 percent from baseline in dyskinesia score) was higher in the INGREZZA 80mg/day group compared to placebo at all study visits. At week six, 40 percent (p<0.001) of participants receiving 80mg/day of INGREZZA had at least a 50% improvement in AIMS dyskinesia score as compared to only 8.7 percent of those who received placebo.
The Kinect 3 study was a Phase III, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in which 234 subjects with TD and underlying schizophrenia, schizoaffective disorder or mood disorder (including bipolar disorder or major depressive disorder) receive six weeks of once-daily INGREZZA (40mg or 80mg capsules) or placebo. Subsequent to the completion of the six week placebo-controlled dosing, all subjects were placed on once-daily 40mg or once-daily 80mg of INGREZZA through week 48.
Safety Profile
During the six-week placebo-controlled treatment period INGREZZA was generally well tolerated and the most common adverse reactions were somnolence and drooling. The frequency of adverse events was similar among all treatment groups and treatment emergent adverse effects were consistent with those of prior studies. There were no drug-drug interactions identified in subjects who were utilizing a wide range of psychotropic and other concomitant medications.
About Tardive Dyskinesia
Tardive dyskinesia is caused by treatments that block dopamine receptors in the brain, such as antipsychotics and other medications. In patients with TD, these treatments are thought to result in excessive dopamine signaling in the region of the brain that controls movement. Tardive dyskinesia is characterized by uncontrollable, abnormal and repetitive movements of the trunk, extremities and/or face. These can include hand or foot movements, rocking of the trunk, lip smacking, grimacing, tongue protrusion, facial movements or blinking, as well as puckering and pursing of the lips. Tardive dyskinesia can cause significant impairment and may lead to social withdrawal, reduced workplace productivity or loss of employment, feeling embarrassed in public, or making others feel uncomfortable.
About INGREZZA
VMAT2 is a protein concentrated in the human brain that is primarily responsible for re-packaging and transporting monoamines (dopamine, norepinephrine, serotonin, and histamine) in pre-synaptic neurons. INGREZZA (valbenazine) capsules, developed in the Neurocrine laboratories, is a novel, selective VMAT2 inhibitor that modulates dopamine release during nerve communication, showing little or no affinity for VMAT1, other receptors, transporters and ion channels. INGREZZA is designed to provide low, sustained, plasma and brain concentrations of active drug to allow for once-daily dosing. The proprietary name INGREZZA has been conditionally accepted by the
Modulation of neuronal dopamine levels in diseases such as tardive dyskinesia, Tourette syndrome, Huntington's chorea, schizophrenia, and tardive dystonia, which are characterized, in part, by a hyperdopaminergic state, may provide symptomatic benefits for patients with these diseases.
The Company has a pending NDA under review by the
About
Forward Looking Statements
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. 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 Neurocrine's business and finances in general, as well as risks and uncertainties associated with INGREZZA development for both tardive dyskinesia and/or Tourette syndrome. Specifically, the risks and uncertainties the Company faces include risks that the INGREZZA NDA may not obtain regulatory approval from the
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