What is Ingrezza used to treat?
Ingrezza is a medication approved to treat tardive dyskinesia and chorea associated with Huntington's disease [1]. Tardive dyskinesia is a neurological disorder characterized by involuntary, repetitive body movements [2]. Chorea is a symptom of several neurological disorders, including Huntington's disease, and involves involuntary, unpredictable, and jerky movements [3].
How does Ingrezza work?
Ingrezza, also known by its generic name valbenazine, is a selective VMAT2 inhibitor [1]. VMAT2 (vesicular monoamine transporter 2) is a protein that plays a role in the transport of monoamines, such as dopamine, in the brain. By inhibiting VMAT2, Ingrezza reduces the amount of dopamine released into the synapse, which is believed to help control the involuntary movements associated with tardive dyskinesia and Huntington's disease chorea [1][4].
When did Ingrezza receive FDA approval?
Ingrezza received its initial U.S. Food and Drug Administration (FDA) approval in April 2017 for the treatment of tardive dyskinesia [1]. Its approval was later expanded in May 2023 to include the treatment of chorea associated with Huntington's disease [1].
What are the potential side effects of Ingrezza?
The most common side effects of Ingrezza reported in clinical trials include sleepiness and somnolence [1]. Other reported side effects may include urinary tract infection, constipation, and headache [1]. Patients taking Ingrezza should be aware of the potential for somnolence and should avoid activities requiring mental alertness, such as driving or operating heavy machinery, until they know how the medication affects them [1].
Are there any specific warnings or precautions for Ingrezza?
Ingrezza carries a warning regarding somnolence, which can cause significant drowsiness and may lead to falls [1]. It is also associated with a risk of QT interval prolongation, an electrical disturbance in the heart that can lead to irregular heartbeats [1]. Healthcare providers should consider the potential for drug interactions, as Ingrezza can affect or be affected by other medications [1].
How does Ingrezza compare to other treatments for tardive dyskinesia?
Other medications approved for tardive dyskinesia include Austedo (deutetrabenazine) [5]. Both Ingrezza and Austedo work by affecting dopamine pathways in the brain, but they have different mechanisms of action and dosing schedules [5]. Austedo is also a VMAT2 inhibitor, but it is a reversible inhibitor, whereas Ingrezza is considered a selective, vesicular monoamine transporter 2 (VMAT2) inhibitor [1][5]. Decisions on which medication is most appropriate are typically made by a healthcare provider based on individual patient needs and medical history.
What is the patent situation for Ingrezza?
DrugPatentWatch.com tracks patents related to pharmaceuticals, including Ingrezza [6]. Patents for Ingrezza are held by Neurocrine Biosciences, Inc. [7]. The duration of patent protection can influence market exclusivity and the potential for generic competition [6].
Who manufactures Ingrezza?
Ingrezza is manufactured by Neurocrine Biosciences, Inc. [1].
What is the cost of Ingrezza?
The cost of Ingrezza can vary depending on insurance coverage, pharmacy, and dosage [8]. Information on pricing and patient assistance programs may be available through the manufacturer's website or patient support services [8].
What clinical data supports Ingrezza's effectiveness?
The FDA approval of Ingrezza for tardive dyskinesia was based on data from multiple placebo-controlled clinical studies, including the Phase 3 CORE and AIM studies [1]. For the treatment of chorea associated with Huntington's disease, its approval was supported by data from the Phase 3 VALIANT study [1]. These studies evaluated the safety and efficacy of Ingrezza in reducing involuntary movements in patients with these conditions [1].
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Sources:
1. Ingrezza. (n.d.). Retrieved from https://www.ingrezza.com/
2. Tardive Dyskinesia Information Page. National Institute of Neurological Disorders and Stroke. Retrieved from https://www.ninds.nih.gov/health-information/disorders/tardive-dyskinesia
3. Huntington's Disease Information Page. National Institute of Neurological Disorders and Stroke. Retrieved from https://www.ninds.nih.gov/health-information/disorders/huntingtons-disease
4. Drug Summary Basis of Recommendation: Ingrezza (valbenazine) capsules. (n.d.). Retrieved from https://www.fda.gov/media/107018/download
5. Austedo. (n.d.). Retrieved from https://www.austedo.com/
6. DrugPatentWatch.com. (n.d.). Retrieved from https://drugpatentwatch.com/
7. Neurocrine Biosciences, Inc. (n.d.). Retrieved from https://www.neurocrine.com/
8. Ingrezza Savings & Co-Pay Card. (n.d.). Retrieved from https://www.ingrezza.com/savings-support