Neurocrine Announces FDA Approval of 80 mg INGREZZA® (valbenazine) Capsules for the Treatment of Adults with Tardive Dyskinesia (TD)
- Category: Small Molecules
- Published on Friday, 06 October 2017 14:51
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First and only TD therapy taken as one capsule, once per day; new 80 mg capsule expected to be available for patients within two weeks
INBRACE™ program offers patients access to treatment and patient assistance
SAN DIEGO, CA, USA I October 5, 2017 I Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that the U.S. Food and Drug Administration (FDA) has approved an 80 mg INGREZZA® (valbenazine) capsule strength to be used for the treatment of adults with tardive dyskinesia (TD). INGREZZA, a novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor, which was approved by the FDA April 11, 2017, is the first FDA-approved product indicated for the treatment of adults with TD.
"INGREZZA continues to be the TD treatment of choice," said Kevin C. Gorman, Chief Executive Officer of Neurocrine Biosciences. "With the approval of the new 80 mg capsule, patients now have access to an even more convenient treatment option. INGREZZA is the only TD therapy to offer simplified dosing with only one capsule once per day."
Clinical studies have shown that INGREZZA 80 mg provided significant, rapid, and meaningful improvement in TD severity compared to placebo at 6 weeks (-3.2 vs -0.1; P values less than or equal to 0.001) with separation seen as early as two weeks, and continued reductions observed through 48 weeks of treatment. INGREZZA was generally well tolerated, with somnolence as the only adverse event occurring at a rate greater than or equal to 5 percent and twice placebo. In clinical trials, generally no worsening in safety scale scores for depression, suicidal ideation or behaviors was observed. INGREZZA has been studied in over 1,000 individuals and more than 20 clinical trials.
The 80 mg capsule of INGREZZA will be available for patients within two weeks through a select pharmacy network. To assist patients living with TD obtain access to INGREZZA, Neurocrine created the INBRACETM patient support program, which accepts treatment initiation forms from health care professionals prescribing INGREZZA and works closely with patients and their families to facilitate access. INBRACE is also designed to provide personalized product assistance and services. For more information, patients may visit www.INGREZZA.com or call 1-84-INGREZZA (1-844-647-3992).
About Tardive Dyskinesia (TD)
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.
INGREZZA, a selective VMAT2 inhibitor, is the first FDA approved product indicated for the treatment of adults with tardive dyskinesia. 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 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 as one capsule, once-daily, together with psychiatric medications such as antipsychotics or antidepressants.
About Neurocrine Biosciences
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.
SOURCE: Neurocrine Biosciences