INGREZZA® SPRINKLE (valbenazine) capsules is now available through the same network of specialty and local affiliated pharmacies that distribute INGREZZA.
"Only INGREZZA offers a sprinkle formulation to ease administration for individuals living with tardive dyskinesia or Huntington's disease chorea, who often have difficulty swallowing pills," said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. "We wanted to provide this new option to patients and their caregivers who want the benefit of treatment with INGREZZA without the challenge of swallowing a capsule."
INGREZZA and INGREZZA SPRINKLE offer simple dosing that's always one capsule, once daily with no complex dose adjustments to get to an effective dose.1 Only INGREZZA and INGREZZA SPRINKLE offer a therapeutic dose from day one.1 INGREZZA SPRINKLE offers the same three simple and effective dosing options (40 mg, 60 mg and 80 mg) as INGREZZA, which can be adjusted by a healthcare provider based on patient response and tolerability.1
The INGREZZA SPRINKLE capsule is easy to open and the contents (granules) can be sprinkled on soft food, such as applesauce, yogurt or pudding, for oral administration. Proper preparation and administration of INGREZZA SPRINKLE is described in the Instructions for Use.
"Most people living with chorea associated with Huntington's disease will experience swallowing issues," said Katie Jackson, President, Help 4 HD International. "The availability of a treatment for chorea that can be easily sprinkled onto food is very helpful in reducing the burden of taking a pill for these individuals and their caregivers, especially as the disease progresses."
Taking pills can also be difficult for people living with TD.2 In a survey of patients with TD experiencing moderate-to-severe involuntary movement symptoms (n = 250), 37% reported that their movements impacted their ability to eat and drink.2*†
Neurocrine Biosciences received U.S. Food and Drug Administration approval of INGREZZA SPRINKLE on April 30 of this year. The approval was based on chemistry, manufacturing and controls information and data demonstrating the bioequivalence and tolerability of INGREZZA SPRINKLE compared with INGREZZA capsules.
The cost of INGREZZA SPRINKLE is equivalent to INGREZZA. The INBRACE® Support Program provided by Neurocrine Biosciences helps patients who are prescribed INGREZZA or INGREZZA SPRINKLE by assisting with product support and prescription fulfillment. Patients with commercial insurance may be eligible for copay assistance, and patients with no prescription coverage who also lack the financial resources to pay for their medicine may be eligible for participation in the patient assistance program. Most patients pay $10 or less out-of-pocket for INGREZZA.
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 associated with taking certain kinds of mental health medicines (antipsychotics) that help control dopamine receptors in the brain. Taking antipsychotics commonly prescribed to treat mental illnesses such as major depressive disorder, bipolar disorder, schizophrenia and schizoaffective disorder and other prescription medicines (metoclopramide and prochlorperazine) used to treat gastrointestinal disorders are associated with TD. 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 approximately 600,000 people in the U.S.
About Chorea Associated with Huntington's Disease (HD):
Huntington's disease (HD) is a hereditary progressive neurodegenerative disorder in which the loss of certain neurons within the brain causes motor, cognitive and psychiatric symptoms. Symptoms generally appear between the ages of 30 and 50 years and worsen over a 10- to 25-year period. Most people with HD experience chorea, an abnormal involuntary movement disorder, characterized by irregular and unpredictable movements. Chorea can affect various body parts and interfere with motor coordination, gait, swallowing and speech. HD is estimated to affect approximately 41,000 adults in the U.S., with more than 200,000 at risk of inheriting the disease.
About INGREZZA® (valbenazine) Capsules and INGREZZA® SPRINKLE (valbenazine) Capsules:
INGREZZA is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease (HD) that is always one capsule, once daily with no complex dose adjustments to get to an effective dose. Only INGREZZA offers a therapeutic dose from day one.
INGREZZA, developed by Neurocrine Biosciences, selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. While the specific way INGREZZA works to treat TD and HD chorea is not fully understood, INGREZZA is unique in that it selectively and specifically targets VMAT2 to inhibit the release of dopamine, a chemical in the brain that helps control movement. INGREZZA is believed to reduce extra dopamine signaling, which may lead to fewer uncontrollable movements.
INGREZZA can be taken as one capsule, once daily together with most stable mental health regimens such as antipsychotics or antidepressants. Only INGREZZA offers the benefit of a sprinkle formulation, INGREZZA® SPRINKLE, for those who experience dysphagia, have difficulty swallowing or prefer not to swallow a pill. INGREZZA and INGREZZA SPRINKLE dosages approved for use are 40 mg, 60 mg and 80 mg capsules.
About Neurocrine Biosciences, Inc.:
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. .
For more information, visit www.neurocrine.com.
