Advancing Tardive Dyskinesia Treatment With New Sprinkle Formulation of Valbenazine

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Leslie Citrome, MD, MPH, clinical professor of psychiatry and behavioral sciences at New York Medical College, shared his reaction to the recently approved new sprinkle formulation of valbenazine for patients with tardive dyskinesia.

Leslie Citrome, MD, MPH, clinical professor of psychiatry and behavioral sciences at New York Medical College

Leslie Citrome, MD, MPH

Credit: LinkedIn

Valbenazine (Ingrezza; Neurocrine Biosciences) is the only available single-capsule, once-daily treatment option with no complex titration for adults with tardive dyskinesia (TD) or chorea associated with Huntington disease (HD).1,2 A selective vesicular monoamine transporter 2 (VMAT2) inhibitor, valbenazine is offered in 3 effective dosages (40 mg, 60 mg and 80 mg) that can be adjusted by the healthcare provider based on patient response and tolerability. Valbenazine was originally approved in 2017 for TD based on the phase 3 KINECT-4 trial (NCT02405091), and later had its indication expanded to include chorea, using data from the phase 3 KINECT-HD study (NCT04102579) and the open-label extension KINECT-HD2 study (NCT04400331).

In recent news, the FDA approved valbenazine oral granules, a new sprinkle formulation of the treatment capsules for oral administration, for patients with TD or chorea associated with HD. The oral granules capsules are intended to be opened for sprinkling on soft foods prior to administration.3 The new drug application filing for the sprinkle formulation included chemistry, manufacturing, and controls information, as well as data demonstrating the bioequivalence and tolerability of the oral granule sprinkle capsules compared with the currently approved valbenazine capsules.4

Leslie Citrome, MD, MPH, clinical professor of psychiatry and behavioral sciences at New York Medical College, recently had a conversation with NeurologyLive® to share his clinical viewpoint on how the FDA approval of valbenazine sprinkle formulation impacts the treatment landscape for TD. He also spoke about the potential benefits of this formulation for patients with difficulty swallowing pills. Additionally, Citrome talked about the challenges that clinicians may face in accurately diagnosing and treating TD, and how education initiatives can help to address these challenges.

Top Clinical Takeaways

  • The availability of valbenazine sprinkles represents an advancement in TD treatment, offering a convenient administration option for patients.
  • Educating clinicians about accurately differentiating TD from other movement disorders is essential to avoid misdiagnosis and inappropriate treatment.
  • The approval of new medications and formulations underscores the importance of ongoing research and awareness efforts in improving TD management.

NeurologyLive: What was your initial reaction to this formulation approval of valbenazine based on your clinical viewpoint?

Leslie Citrome: I've been involved in the TD space for several decades so I'd like to put this into perspective. I never thought that there would be an FDA approved medication for TD. I was pleasantly surprised a few years ago with the approval of both valbenazine and deutetrabenazine (Austedo XR; Teva Pharmaceuticals) for the treatment of TD. This makes it easier for us to address TD amongst our patients whereas in the past, we really floundered.

I'm pleased that we have these choices, and I'm even more pleased that they're coming in different formulations. We've seen advances in formulations with deutetrabenazine once a day and now with valbenazine sprinkles. This will make these drugs more available to more patients.

With more drugs and more formulations, we're all better off in effectively addressing TD. Valbenazine sprinkles will make it possible to give a VMAT2 inhibitor to patients who may have had trouble swallowing pills - it is intended to be sprinkled on soft foods prior to administration. I'm keen on having that formulation available for that purpose.

What does this approval mean for patients with this condition?

VMAT2 inhibitors are the only medications that are approved for TD. I hope that additional information about these drugs make them our first choice for the treatment of TD and thus avoid treatments that don't work. I'm happy that we'll have additional facts to talk about VMAT2 inhibitors and that valbenazine sprinkles offers yet another opportunity to have this conversation about the effective treatment of TD.

What do you think is a remaining unmet need among those in this patient population?

I think the biggest unmet need is a lack of accurate differential diagnosis for movement disorders in that clinicians may mistake TD for other movement disorders and treat it with an ineffective medication. An example of this is the use of benztropine or other anticholinergic agents in an attempt to treat TD when in fact these medications can make TD worse.

In this patient population, where do you see the field moving in terms of treatments and trying to address unmet needs among patients?

As mentioned, I think we need to do a better job in educating about differentiating TD from other movement disorders, and that different movement disorders are treated with different interventions. Having a new formulation of valbenazine provides us with a new opportunity to have that conversation again.

Transcript edited for clarity.

REFERENCES
1. Neurocrine Biosciences Announces FDA Approval of INGREZZA® (valbenazine) Capsules for the Treatment of Chorea Associated With Huntington's Disease. News Release. Neurocrine Biosciences. Published August 18, 2023. Accessed May 1, 2024. https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-fda-approval-of-ingrezza-valbenazine-capsules-for-the-treatment-of-chorea-associated-with-huntingtons-disease-301904823.html
2. Neurocrine announces FDA approval of Ingrezza TM (valbenazine) capsules as the first and only approved treatment for adults with tardive dyskinesia (TD). News release. April 11, 2017. Accessed May 1, 2024. https://www.prnewswire.com/news-releases/neurocrine-announces-fda-approval-of-ingrezza-tm-valbenazine-capsules-as-the-first-and-only-approved-treatment-for-adults-with-tardive-dyskinesia-td-300438338.html
3. Neurocrine Biosciences Announces U.S. FDA Approval of INGREZZA® SPRINKLE (valbenazine) Capsules. News release. Neurocrine. April 30, 2024. Accessed May 1, 2024. https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-us-fda-approval-of-ingrezza-sprinkle-valbenazine-capsules-302132283.html
4. Neurocrine Biosciences Announces U.S. FDA Accepts New Drug Application for INGREZZA® (valbenazine) Oral Granules Sprinkle Formulation. News Release. Published September 14, 0223. Accessed May 1, 2024. https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-us-fda-accepts-new-drug-application-for-ingrezza-valbenazine-oral-granules-sprinkle-formulation-301926943.html
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