Full Press Release Details
SAN DIEGO , May 18, 2017 /PRNewswire/ -- Neurocrine Biosciences Inc. (NASDAQ: NBIX ) announced today the upcoming presentation at the American Psychiatric Association (APA) Annual Meeting of pharmacokinetic data, as well as long-term data from the KINECT 3 Phase III extension study of INGREZZA ® (valbenazine) capsules for the treatment of adults with TD.
"This year's annual meeting of the APA is an excellent opportunity to present additional data and analyses from the extensive clinical development program both supporting and differentiating INGREZZA," said Chris O'Brien , M.D., Chief Medical Officer of Neurocrine. "We are particularly pleased to share this information with Psychiatrists who now have access to the first and only FDA approved treatment for TD patients."
The APA Annual Meeting is May 20-24, 2017 , in San Diego , CA. Neurocrine's oral presentation on Saturday, May 20, 2017 in a session from 8:00 a.m. – 11:00 a.m. PT is:
The four posters presented during New Research Posters 1 Session on Monday, May 22, 2017 from 10:00 a.m. – 12:00 p.m. PT are:
About Tardive Dyskinesia (TD)
TD is characterized by uncontrollable, abnormal and repetitive movements of the trunk, extremities and/or face. The condition is caused by 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.
INGREZZA, a selective VMAT2 inhibitor, is the first and only product indicated for the treatment of adults with tardive dyskinesia. The approval of INGREZZA was based on data from the Kinect 3 study, a Phase III, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study comparing once-daily INGREZZA 80mg and 40mg to placebo over six weeks in patients with underlying schizophrenia, schizoaffective disorder or mood disorder. Subsequent to the completion of the six week placebo-controlled dosing, all eligible subjects were placed on once-daily 40mg or once-daily 80mg of INGREZZA through week 48. INGREZZA met the primary endpoint in this study with a mean change from baseline to week six in the AIMS dyskinesia total score of -3.2 for the 80mg once-daily group as compared to -0.1 in the placebo group (p <0.0001). Also in the Kinect 3 study:
INGREZZA inhibits VMAT2 and 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 TD. 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 together with existing stable psychiatric medications such as antipsychotics or antidepressants.
IMPORTANT SAFETY INFORMATION
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.
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 (greater than or equal to 5% and twice the rate of placebo) is somnolence. Other adverse reactions (greater than or equal to 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.
Please see INGREZZA full Prescribing Information at www.INGREZZA.com .
About Neurocrine Biosciences
Neurocrine Biosciences is a San Diego based biotechnology company focused on neurologic, psychiatric and endocrine related disorders. In April of 2017, the FDA approved INGREZZA ® (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD). INGREZZA is a novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor, and is the first and only FDA-approved product indicated for the treatment of adults with TD. The company markets INGREZZA in the United States . 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 (valbenazine), 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 at http://www.neurocrine.com .
Forward Looking Statements
SOURCE Neurocrine Biosciences, Inc.