SAN DIEGO, April 18, 2018 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced that new data for once-daily INGREZZA® (valbenazine) capsules, the first U.S. Food and Drug Administration (FDA) approved treatment for adults with tardive dyskinesia (TD), will be presented at the American Academy of Neurology (AAN) Annual Meeting in Los Angeles, Calif., April 21-27, 2018. Highlighted presentations include analysis of the short- and long-term effects of INGREZZA on TD symptoms by body region, long-term INGREZZA safety and efficacy data from the KINECT 4 Phase III open-label study and data from RE-KINECT, a real-world screening study of patients with possible TD.
"The symptoms of tardive dyskinesia are heterogeneous, with each patient experiencing tardive dyskinesia somewhat differently. Patients can experience uncontrollable, abnormal and repetitive movements in different regions of the body, including the trunk, extremities and face. Symptoms can also change over time," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine. "For these reasons it is important for us to assess the effects of INGREZZA by body region and to understand the long-term efficacy and tolerability of INGREZZA. We look forward to presenting these additional data to help neurologists further understand the potential of INGREZZA as a treatment for tardive dyskinesia."
Four Neurocrine posters will be presented during the "Movement Disorders: Tardive Dyskinesia" poster session on Wednesday, April 25, 2018 from 5:30 - 7:00 p.m. PT:
Short- and Long-term Effects of Once-Daily Valbenazine on Tardive Dyskinesia by Body Region (P4-079)
Effects of Long-term Valbenazine on Tardive Dyskinesia and Patient-Reported Outcomes: Results from the KINECT 4 Study (P4-078)
RE-KINECT: A Prospective Real-world Dyskinesia Screening Study and Registry in Patients Taking Antipsychotic Agents: Patient Demographics (P4-083)
Estimation of an MCID for AIMS Total Score Change in Tardive Dyskinesia (P4-074)
About Tardive Dyskinesia (TD) Tardive dyskinesia (TD) is characterized by uncontrollable, abnormal and repetitive movements of the trunk, extremities and/or face. The condition is associated with 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 may 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 FDA approved product indicated for the treatment of adults with tardive dyskinesia, a condition associated with uncontrollable, abnormal and repetitive movements of the trunk, extremities and/or face.
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 Warnings & Precautions Somnolence 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.
QT Prolongation 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.
Adverse Reactions 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-FDA-1088.
About Neurocrine Biosciences, Inc. Neurocrine Biosciences is a San Diego based biotechnology company focused on neurologic, psychiatric and endocrine related disorders. The Company markets INGREZZA® (valbenazine) capsules in the United States for the treatment of adults with tardive dyskinesia. INGREZZA is a novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor, and is the first FDA approved product indicated for the treatment of adults with tardive dyskinesia. The Company's three late-stage clinical programs are: elagolix, a gonadotropin-releasing hormone antagonist for women's health that is partnered with AbbVie Inc.; opicapone, a novel, once-daily, peripherally-acting, highly-selective catechol-o-methyltransferase inhibitor under investigation as adjunct therapy to levodopa in Parkinson's patients; and INGREZZA, a novel, once-daily, selective VMAT2 inhibitor under investigation for the treatment of Tourette syndrome.
Neurocrine Biosciences, Inc. news releases are available through the Company's website via the internet at http://www.neurocrine.com.
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 related to the benefits to be derived from INGREZZA and whether results from INGREZZA's clinical trials are indicative of real-world results. 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 the commercialization of INGREZZA; risks that INGREZZA clinical trials results may not be predictive of real-world results or of results in subsequent clinical trials; risks and uncertainties relating to competitive products and technological changes 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 FDA or other regulatory authorities may make adverse decisions regarding INGREZZA; risks that INGREZZA may be alleged to infringe upon the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's annual report on Form 10-K for the year ended December 31, 2017. Neurocrine disclaims any obligation to update the statements contained in this press release after the date hereof.