FDA Approves Oral Valbenazine Granule Formulation, an Alternative Administration Option for Adults With TD
At the end of April, Neurocrine Biosciences, Inc. announced the approval of INGREZZA® SPRINKLE (valbenazine) capsules by the US Food and Drug Administration (FDA), providing an alternate medication option for adults with tardive dyskinesia (TD) and chorea associated with Huntington disease. This approval provides an alternative option for patients with dysphagia or who have difficulty swallowing.
"We developed INGREZZA SPRINKLE to make administration easier for patients who have difficulty swallowing or prefer not to take a capsule," said Eiry W. Roberts, MD, chief medical officer at Neurocrine Biosciences in a news release. "We are pleased to offer the proven efficacy of INGREZZA in reducing uncontrollable movements in a new formulation."
Related: TD Has ‘Severe Impact’ on Patients and Caregivers
Valbenazine is a vesicular monoamine transporter 2 (VMAT2) inhibitor that offers 3 dosages (40 mg, 60 mg, and 80 mg) that can be adjusted based on patient response and tolerability. The new valbenazine formulation offers the same dosages as the original formulation, and the capsule contents can be sprinkled on soft foods for easy oral administration.
In a survey administered by the manufacturer, of patients with chorea associated with HD and their caregivers, of the 62% of the 78 respondents reported difficulty swallowing caused by their involuntary movements. In another survey of patients with TD experiencing moderate-to-severe involuntary moment symptoms, of the 250 respondents, 37% reported their ability to eat or drink was impacted by their involuntary movements.
Valbenazine was the first drug to be approved by the FDA for TD treatment as a pill in 2017.
"Until now, one of the few options for physicians, when managing TD, was to stop, change or lower the dose of antipsychotic medication, potentially jeopardizing patients' psychiatric stability," said Christoph U. Correll, MD, Hofstra Northwell School of Medicine in a press release at the time of approval. "In clinical trials, INGREZZA significantly and rapidly improved TD symptoms compared to placebo, reducing involuntary movements acutely and through 48 weeks of treatment without compromising underlying psychiatric care. These results, combined with convenient once-daily dosing, represent a tremendous breakthrough for patients suffering from TD."
FDA approves first drug to treat tardive dyskinesia. FDA. Aprill 11, 2017. Accessed May 15, 2024.
