TREATING HD CHOREA WITH ONE‑CAPSULE, ONCE‑DAILY INGREZZA
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INGREZZA TAKES HD CHOREA CONTROL A STEP FORWARD
In the clinical study, most people began to experience improvement at 2 weeks.* Significant improvement was shown at 12 weeks vs placebo.†
* Patients had at least a 1-point reduction in TMC score at 2 weeks vs before treatment. This post-clinical study evaluation included 64 patients taking INGREZZA 40 mg, measuring HD chorea before starting treatment and at 2 weeks of treatment.
† INGREZZA was studied in a 12-week clinical trial. A total of 128 patients participated in the study. Results were based on 64 patients taking INGREZZA 40 mg, 60 mg, or 80 mg. The primary efficacy endpoint was change in TMC from the baseline to maintenance periods.
INGREZZA SIGNIFICANTLY IMPROVED HD CHOREA
People taking INGREZZA experienced greater HD chorea improvement vs placebo as measured by TMC score‡
Most people taking INGREZZA experienced clinically meaningful improvement at 12 weeks§
People taking INGREZZA experienced greater HD chorea improvement vs placebo as measured by TMC score‡
Most people taking INGREZZA experienced clinically meaningful improvement at 12 weeks§
‡ 4.6-point improvement seen with INGREZZA vs 1.4 with placebo in TMC score from the start to the end of the 12-week clinical study.
§ Most patients (57%) experienced clinically meaningful improvements, defined as a 4-point or greater change in TMC score.
Significantly more patients and healthcare providers reported improvement with INGREZZA
53% of people
in the clinical study reported their overall HD chorea as “very much improved” or “much improved” with the help of INGREZZA vs 26% for placebo at 12 weeks.‖
‖ Based on patient-reported chorea severity (PGI-C scale) at 12 weeks vs before treatment.
43% of healthcare professionals
in the clinical study reported HD chorea as “very much improved” or “much improved” with the help of INGREZZA vs 13% for placebo at 12 weeks.¶
¶ Based on clinician-reported chorea severity (CGI-C scale) at 12 weeks vs before treatment.
‖ Based on patient-reported chorea severity (PGI-C scale) at 12 weeks vs before treatment.
¶ Based on clinician-reported chorea severity (CGI-C scale) at 12 weeks vs before treatment.
EXPLORING ADDITIONAL OUTCOMES OF TREATING HD CHOREA WITH INGREZZA
In the clinical study, researchers wanted to explore some of the additional ways that treatment with INGREZZA might benefit people living with HD. One of the ways they did this was by using the Huntington’s Disease Health Index, or HD-HI.#
On average, people taking INGREZZA had greater improvements vs people taking placebo in 8 of 13 categories measured by the HD-HI at 12 weeks#:
Categories that particularly affect people with HD chorea
Other categories that were measured
# The Huntington’s Disease Health Index (HD-HI) is a patient-reported outcome designed to measure clinically meaningful changes in 13 HD-specific categories in response to treatment. To conduct this exploratory analysis, the HD-HI was administered at baseline, week 10, and week 12. Observed values and score changes from baseline to week 12 (valbenazine n=64) were summarized descriptively by treatment group and visit.
INGREZZA does not cure the cause of involuntary movements and it does not treat other symptoms of Huntington's disease, such as problems with thinking or emotions.
Learn more about the INGREZZA clinical study
128 PEOPLE enrolled for 12 weeks
The goal of the study was to see if people taking INGREZZA experienced improvements in their HD chorea as measured by changes in TMC (Total Maximal Chorea) score. Approximately 120 people who completed the study were then enrolled in a 3-year extension to evaluate the long-term safety and effectiveness of INGREZZA in the treatment of HD chorea.
PEOPLE TAKING INGREZZA CAN STAY ON MOST OF THEIR STABLE MENTAL HEALTH MEDICATIONS
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
SAFETY AND SIDE EFFECTS
Nearly all people (9 in 10) taking INGREZZA completed the full 12-week clinical study, with 4 in 5 able to tolerate the highest dose.
In the clinical trial, INGREZZA was shown to be generally well tolerated.
In the clinical trial, INGREZZA was shown to be generally well tolerated.
INGREZZA can cause serious side effects in people with Huntington’s disease, including: depression, suicidal thoughts, or suicidal actions. Tell your healthcare provider before you start taking INGREZZA if you have Huntington’s disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself.
The most common side effects of INGREZZA in people with Huntington’s disease are sleepiness (somnolence), allergic itching, rash, and trouble getting to sleep or staying asleep.
INGREZZA may cause serious side effects, including:
- Depression and suicidal thoughts
- Sudden swelling from an allergic reaction (angioedema)
- Heart rhythm problems
- Neuroleptic Malignant Syndrome (NMS)
- Abnormal movements, including shaking, body stiffness, trouble moving or walking or keeping your balance
These are not all of the possible side effects of INGREZZA.
If you experience side effects, call your healthcare provider for medical advice. To report side effects to the FDA, call 1-800-FDA-1088.
People with Huntington's disease have a higher risk of depression and suicidal thoughts or actions. INGREZZA is a VMAT2 inhibitor. VMAT2 inhibitors are a group of medicines that all include a warning that they could increase this risk.
HOW INGREZZA WORKS
Unlike other medications approved to treat HD chorea, INGREZZA selectively and specifically targets a protein called VMAT2.** VMAT2 aids in the release of dopamine.
Current research suggests that INGREZZA reduces abnormal dopamine signaling that causes HD chorea. However, how INGREZZA works to treat HD chorea is not fully understood.
**Based on laboratory tests. This does not imply a treatment advantage.
Dopamine is a chemical in the brain that helps control movement.
HD chorea may be caused by too much dopamine signaling in the brain.
INGREZZA selectively and specifically targets VMAT2**, a protein that aids in the release of dopamine…
…which is believed to reduce this abnormal dopamine signaling.
Ready to take HD chorea control a step forward?
The Doctor Discussion Guide has tips for talking to a healthcare provider about your uncontrollable movements and HD chorea treatment options.
