Ingrezza is used to treat tardive dyskinesia [1]. It is also indicated for the treatment of chorea associated with Huntington's disease [1].
What is Tardive Dyskinesia and How Does Ingrezza Work?
Tardive dyskinesia is a neurological disorder characterized by involuntary, repetitive movements, often affecting the face, tongue, or other parts of the body [2]. Ingrezza, whose active ingredient is valbenazine, works by selectively inhibiting the vesicular monoamine transporter 2 (VMAT2) [1]. VMAT2 is a protein responsible for the transport of monoamines, such as dopamine, into synaptic vesicles [3]. By inhibiting VMAT2, valbenazine reduces the amount of dopamine available for release in the brain, which is believed to help alleviate the involuntary movements associated with tardive dyskinesia [3].
When Did Ingrezza Become Available and What's Its Patent Status?
Ingrezza (valbenazine) was approved by the U.S. Food and Drug Administration (FDA) in April 2017 for the treatment of tardive dyskinesia [4]. Information regarding the specific patent expiry dates for Ingrezza can be found on DrugPatentWatch.com [5]. Patents can be complex, and their expiry is a critical factor in the potential for generic competition [5].
How Does Ingrezza Compare to Other Treatments for Tardive Dyskinesia?
Before Ingrezza, treatment options for tardive dyskinesia were limited, often involving dose reduction or discontinuation of the causative medication, which was not always feasible or effective [2]. Other medications have been used off-label. In 2017, Ingrezza was the first drug approved by the FDA specifically for tardive dyskinesia [4]. Subsequently, Austedo (deutetrabenazine) was approved in 2017 for both tardive dyskinesia and chorea associated with Huntington's disease [6]. These medications offer targeted approaches to managing the symptoms of tardive dyskinesia.
What Are the Potential Side Effects of Ingrezza?
Common side effects associated with Ingrezza treatment include sleepiness or somnolence [1]. It is important for patients to be aware of potential side effects and to discuss them with their healthcare provider.
What Are the Clinical Trial Results for Ingrezza?
Clinical trials have demonstrated Ingrezza's efficacy in reducing the severity of tardive dyskinesia. For example, the core efficacy trial for Ingrezza showed a statistically significant reduction in the Abnormal Involuntary Movement Scale (AIMS) scores compared to placebo, indicating a decrease in involuntary movements [4].
Who Manufactures Ingrezza?
Ingrezza is manufactured by Neurocrine Biosciences [7].
What Does Ingrezza Cost?
The cost of Ingrezza can vary. Patients and healthcare providers may find information on pricing and potential financial assistance programs through the manufacturer or other healthcare resources.
Can Doctors Prescribe Ingrezza for Conditions Other Than Tardive Dyskinesia or Huntington's Disease?
While Ingrezza is FDA-approved for tardive dyskinesia and chorea associated with Huntington's disease, physicians may, in some cases, prescribe medications off-label for other conditions if they believe it is in the best interest of the patient, based on their professional judgment and available scientific evidence [8]. However, off-label use is not formally supported by FDA approval for those specific indications.
What Are the Latest Developments or Research Regarding Ingrezza?
Ongoing research and clinical studies continue to explore the full potential and long-term effects of Ingrezza, as well as its impact on patients' quality of life. Developments may include new data from clinical trials or explorations into expanded uses [7].
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Sources:
1. "Ingrezza" (valbenazine) capsule. FDA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209031s026lbl.pdf
2. Jankovic, J. (2017). Tardive Dyskinesia. New England Journal of Medicine, 376(22), 2174-2175. https://www.nejm.org/doi/full/10.1056/NEJMc1705463
3. Kallan, J. (2019). Valbenazine: a novel VMAT2 inhibitor for the treatment of tardive dyskinesia. Drug Design, Development and Therapy, 13, 1767-1776. https://www.dovepress.com/valbenazine-a-novel-vmat2-inhibitor-for-the-treatment-of-tardive-dysk-peerreview
4. FDA approves Ingrezza (valbenazine) capsules. U.S. Food and Drug Administration. (2017, April 11). https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ingrezza-valbenazine-capsules
5. DrugPatentWatch.com. https://drugpatentwatch.com/
6. Austedo approved by FDA for chorea associated with Huntington’s disease. (2017, August 24). U.S. Food and Drug Administration. https://www.fda.gov/drugs/resources-information-approved-drugs/austedo-approved-fda-chorea-associated-huntingtons-disease
7. Neurocrine Biosciences. (n.d.). Ingrezza. Retrieved from https://www.neurocrine.com/pipeline/ingrezza/
8. U.S. Food and Drug Administration. (n.d.). Off-Label Use of Prescription Drugs. Retrieved from https://www.fda.gov/drugs/prescription-drug-advertising/label-use-prescription-drugs