Ingrezza Sprinkle, for chorea due to Huntington’s, now available in US
Once-daily therapy comes in capsules to be opened and sprinkled on soft foods
Ingrezza Sprinkle, a new formulation of Ingrezza (valbenazine) that’s designed to be easier to swallow, is now available in the U.S, Neurocrine Biosciences, which markets the therapy, announced.
Ingrezza Sprinkle comes in capsules that are meant to be opened and the contents sprinkled over soft foods like yogurt, pudding, or applesauce. It is available through the same network of pharmacies that distribute Ingrezza, whose capsules are swallowed whole.
Both formulations are approved to treat adults with chorea (jerky, uncontrolled movements) caused by Huntington’s disease, and adults with a movement disorder known as tardive dyskinesia, which is characterized by facial tics.
“Ingrezza Sprinkle was created to address the challenge some patients living with Huntington’s disease chorea and tardive dyskinesia face with swallowing medications,” Eiry Roberts, MD, Neurocrine’s chief medical officer, said in an emailed statement to Huntington’s Disease News. “Our aim is to make treatment easier for patients and caregivers by providing a convenient sprinkle option that lessens the burden of swallowing a pill.”
Both Ingrezza forms come as capsules, with range of doses offered
Ingrezza was approved by the U.S. Food and Drug Administration (FDA) as a treatment for Huntington’s-associated chorea last year, based on clinical trial data showing the therapy was more effective than a placebo at easing this common Huntington’s symptom.
Earlier this year, the FDA extended its approval to cover Ingrezza Sprinkle as a granulated formulation, which was shown to have comparable movements into, through, and out of the body, as well as similar drug exposure to the original capsule formulation.
Both offer simple dosing “that’s always one capsule, once daily with no complex dose adjustments to get to an effective dose,” the release stated. Capsules for each formulation are available at 40, 60, and 80 mg doses.
“Only Ingrezza offers a sprinkle formulation to ease administration for individuals living with tardive dyskinesia or Huntington’s disease chorea, who often have difficulty swallowing pills,” Roberts said in a press release from Neurocrine.
Huntington’s is an inherited, progressive neurodegenerative disease characterized by motor and nonmotor disease symptoms. Its hallmark motor symptom is chorea, which affects about 90% of patients and can involve several parts of the body. It can impair a person’s motor coordination, walking ability, and posture, as well as swallowing (dysphagia) and speech.
“Most people living with chorea associated with Huntington’s disease will experience swallowing issues,” said Katie Jackson, president of the advocacy organization Help 4 HD International. “The availability of a treatment for chorea that can be easily sprinkled onto food is very helpful in reducing the burden of taking a pill for these individuals and their caregivers, especially as the disease progresses.”
Ingrezza and Ingrezza Sprinkle work by blocking the activity of vesicular monoamine transporter 2 (VMAT2), a protein involved in communication between nerve cells in the brain.
Although the detailed mechanism isn’t fully understood, the medications are thought to help normalize the release of certain brain signaling molecules during nerve cell communication, thereby lessening chorea.
The most common side effects of both formulations in Huntington’s patients include sleepiness, rash, hives, and insomnia. The therapies’ combined label also carries a boxed warning noting that the treatment can increase the risk of depression and suicidal tendencies.
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