The US Food and Drug Administration (FDA) has approved an alternative formulation for Neurocrine Biosciences’ Huntington’s disease therapy, Ingrezza (valbenazine).
The new formulation, marketed as Ingrezza Sprinkle, offers an alternative administration option for adults with tardive dyskinesia and chorea associated with Huntington’s disease, who have difficulty swallowing. The formulation is intended to be opened and sprinkled on soft food for easier administration.
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The FDA approval was based on the chemistry, manufacturing, and control information and data, which established the bioequivalence of the two formulations. Similar to the oral capsules, Ingrezza Sprinkle is also available in 40mg, 60mg and 80mg doses.
First approved to treat tardive dyskinesia in 2017, Ingrezza has proven to be a strong earner for Neurocrine, generating $506m in revenue in Q1 2024, as per Neurocrine’s financials. Its sales are expected to increase, and the drug is forecasted to pull in over $3.3bn in sales in 2030, as per GlobalData analysis.
GlobalData is the parent company of Pharmaceutical Technology.
Ingrezza is a selective and reversible inhibitor of the vesicular monoamine transporter 2, which is involved in the uptake of monamines from the cell’s cytoplasm into its synaptic vesicle, where they are either stored or bound for release. However, the exact mechanism of action is unknown, as per Neurocrine.
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By GlobalDataTardive dyskinesia is a rare involuntary neurological movement disorder. Last year, the FDA expanded the Ingrezza label as a treatment for chorea, which describes involuntary, irregular or unpredictable muscle movements, associated with Huntington’s disease.
Neurocine has been in the news recently for its other therapies such as NBI-1065845, a treatment for major depressive disorder (MDD) that was licensed by the company from Takeda Pharmaceuticals in 2020. Last month, Neurocine released positive topline data from the Phase II SAVITRI trial that evaluated the drug in adults with treatment-resistant MDD. The study met its primary endpoint by showing statistically significant changes from baseline on a depression severity scale called the Montgomery Åsberg Depression Rating Scale (MADRS) after 28 days, for one of the two doses tested in the trial.
