Neurocrine Biosciences Receives FDA Approval for INGREZZA® SPRINKLE Capsules (valbenazine)

Thursday, May 02, 2024

Neurocrine Biosciences, Inc. (Nasdaq: NBIX) has announced that the U.S. Food and Drug Administration has granted approval for INGREZZA® SPRINKLE (valbenazine) capsules, a novel oral granules format of INGREZZA® (valbenazine) capsules indicated for treating adults with tardive dyskinesia and chorea linked with Huntington's disease. INGREZZA SPRINKLE presents an alternative administration method for individuals encountering dysphagia or difficulty in swallowing.

Similar to the original INGREZZA capsules, INGREZZA SPRINKLE offers simple once-daily dosing with just one capsule, without requiring complex titration. INGREZZA is the sole selective vesicular monoamine transporter 2 (VMAT2) inhibitor offering three effective dosages (40 mg, 60 mg, and 80 mg) that can be adjusted by healthcare providers based on patient response and tolerance. INGREZZA SPRINKLE provides the same dosage strengths, with the capsule contents easily sprinkled on soft food for oral intake.

Dr. Eiry W. Roberts, Chief Medical Officer at Neurocrine Biosciences, commented, "We developed INGREZZA SPRINKLE to simplify administration for patients who struggle with swallowing or prefer alternatives to capsules. We're delighted to extend the proven efficacy of INGREZZA in reducing uncontrollable movements through this new formulation."

For individuals with chorea associated with Huntington's disease and those experiencing tardive dyskinesia, swallowing pills can pose challenges:

• In a survey involving patients with chorea associated with HD and their caregivers (n = 78), 62% reported difficulty swallowing due to involuntary movements.
• In a survey of patients with TD experiencing moderate-to-severe involuntary movement symptoms (n = 250), 37% reported that their movements affected their ability to eat and drink.

The FDA's approval was based on data demonstrating the bioequivalence and tolerability of INGREZZA SPRINKLE compared to INGREZZA capsules, along with chemistry, manufacturing, and controls information.

Tardive Dyskinesia (TD) is a movement disorder characterized by uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts, often associated with certain mental health medications. Huntington's disease (HD) is a hereditary progressive neurodegenerative disorder marked by motor, cognitive, and psychiatric symptoms, with chorea being a common symptom.

INGREZZA® (valbenazine) Capsules is the sole once-daily selective VMAT2 inhibitor approved by the FDA for treating adults with tardive dyskinesia and chorea associated with Huntington's disease. INGREZZA selectively inhibits VMAT2, believed to reduce extra dopamine signaling, thus potentially leading to fewer uncontrollable movements. It can be taken alongside most psychiatric medications, with dosages available in 40 mg, 60 mg, and 80 mg capsules.

Important safety information regarding potential serious side effects, including depression, suicidal thoughts, allergic reactions, sleepiness, heart rhythm problems, Neuroleptic Malignant Syndrome (NMS), and Parkinson-like symptoms, is provided. It is essential for patients to inform their healthcare providers about all medical conditions and medications before starting INGREZZA or INGREZZA SPRINKLE.

Dosage Forms and Strengths: INGREZZA is available in 40 mg, 60 mg, and 80 mg capsules. INGREZZA SPRINKLE is available in 40 mg, 60 mg, and 80 mg oral granules in capsules. Full prescribing information, including boxed warnings and medication guides, should be reviewed by patients and healthcare providers.

Source: prnewswire.com