Associated tags: VMAT2, Dopamine, Brain, Capsule, VMAT1, Neurocrine Biosciences, HD, Tardive dyskinesia, Chorea, D2, Food, Pharmaceutical industry, SAN, Huntington's disease, Disease, FDA, Poster, Week, Patient, Maintenance, HSG, FAAN, Neurology, Somnolence, McGovern Medical School
Locations: TD
FDA,
Capsule,
Dysphagia,
Neurocrine Biosciences,
Huntington's disease,
Food,
Tardive dyskinesia,
HD,
Patient,
Chemistry,
Caregiver,
VMAT2,
Chorea,
SAN,
Pharmaceutical industry SAN DIEGO, April 30, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration has approved INGREZZA® SPRINKLE (valbenazine) capsules, a new oral granules formulation of INGREZZA® (valbenazine) capsules prescribed for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease.1 INGREZZA SPRINKLE provides an alternative administration option for those who experience dysphagia or have difficulty swallowing.
Key Points:
- SAN DIEGO, April 30, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration has approved INGREZZA® SPRINKLE (valbenazine) capsules, a new oral granules formulation of INGREZZA® (valbenazine) capsules prescribed for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease.1 INGREZZA SPRINKLE provides an alternative administration option for those who experience dysphagia or 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, M.D., Chief Medical Officer at Neurocrine Biosciences.
- "We are pleased to offer the proven efficacy of INGREZZA in reducing uncontrollable movements in a new formulation."
- ‡,†
The U.S. Food and Drug Administration (FDA) approval was based on chemistry, manufacturing, and controls information and data demonstrating the bioequivalence and tolerability of INGREZZA SPRINKLE compared to INGREZZA capsules.
Retrieved on:
Thursday, November 2, 2023
Week,
Falls,
Food,
Fatigue,
HD,
Treatment,
Neurocrine,
Disease,
Neurocrine Biosciences,
Maintenance,
Journal,
Somnolence,
Poster,
Abstract,
Huntington's disease,
Interim,
Capsule,
George Huntington,
HSG,
Food and Drug Administration,
SAN,
Dietary supplement,
Pharmaceutical industry,
Chorea Interim data suggest one-capsule, once-daily INGREZZA improved chorea at the first evaluation at Week 2 with sustained efficacy through Week 50.
Key Points:
- Interim data suggest one-capsule, once-daily INGREZZA improved chorea at the first evaluation at Week 2 with sustained efficacy through Week 50.
- These data will be presented at the 30th Annual Meeting of the Huntington Study Group on November 2–4 in Phoenix.
- "These interim data provide insight on the clinically meaningful and sustained improvements participants are experiencing with INGREZZA for the treatment of chorea," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences®.
- Additional HD chorea presentations at the 30th Annual Meeting of the HSG include:
The full abstracts can be accessed on the Journal of Huntington's Disease website.
DSM-IV codes,
TD,
Week,
Schizophrenia,
Disease,
Abnormality (behavior),
Neurocrine Biosciences,
AIMS,
HCP,
MDS,
Movement,
Data analysis,
Poster,
Patient,
SAN,
Parkinson's disease,
Pharmaceutical industry,
Nursing The data (Poster #657) was presented at the MDS International Congress of Parkinson's Disease and Movement Disorders® in Copenhagen, Denmark.
Key Points:
- The data (Poster #657) was presented at the MDS International Congress of Parkinson's Disease and Movement Disorders® in Copenhagen, Denmark.
- The insight gained from these data also supports the efficacy of treatment with INGREZZA in reducing both HCP-perceived severity and patient-reported impact of TD."
- TD severity and distress decreased, with most patients scored with minimal severity (AIMS8=1) and as aware/no distress at 48 weeks (AIMS10=1).
- (n=167)
Additional presentation at the MDS International Congress of Parkinson's Disease and Movement Disorders® includes:
Huntington's disease,
Pit additive,
KINECT,
Lancet Neurology,
Week,
Disease,
McGovern Medical School,
Neurocrine Biosciences,
Clinical Global Impression,
Movement disorder,
The Lancet,
MDS,
Capsule,
Movement,
TMC,
SAN,
Chorea,
Parkinson's disease,
FANA,
Neurology,
Poster,
FAAN,
FDA,
Safety,
Pharmaceutical industry,
HD SAN DIEGO, Aug. 28, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new data on now FDA-approved INGREZZA® (valbenazine) capsules for the treatment of adults with chorea associated with Huntington's disease (HD), including exploratory results from the Phase 3 KINECT®-HD study, which showed consistently greater improvements in HD chorea with INGREZZA versus placebo from Week 2 to Week 12. These data will be presented at the MDS International Congress of Parkinson's Disease and Movement Disorders®August 27-31 in Copenhagen, Denmark.
Key Points:
- These data will be presented at the MDS International Congress of Parkinson's Disease and Movement Disorders®August 27-31 in Copenhagen, Denmark.
- "The exploratory analysis from our KINECT-HD study further exemplifies the value of INGREZZA as a now approved medication for HD chorea with improvements seen with treatment as early as two weeks," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences.
- "This exploratory analysis has increased our insight regarding the early and sustained improvements in chorea severity."
- Additional HD chorea presentations at the MDS International Congress of Parkinson's Disease and Movement Disorders include:
Huntington's disease,
Maintenance,
VMAT2,
Chorea,
Depression,
Pharmacy,
Somnolence,
Disease,
Huntington's Disease Society of America,
Neurocrine Biosciences,
Quality of life,
Medicine,
NMS,
Hives,
Behavior,
Rash,
HSG,
Insomnia,
Capsule,
LSM,
TMC,
Patient,
McGovern Medical School,
Neuroleptic malignant syndrome,
SAN,
FANA,
Suicidal ideation,
FDA,
Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
FAAN,
Food,
Caregiver,
Safety,
Pharmaceutical industry,
Birth control,
HD,
Neurology "We are thankful for those in the HD community who helped contribute to this important milestone, and we remain committed to bringing medicines to patients with unmet medical needs for debilitating neurological disorders."
Key Points:
- "We are thankful for those in the HD community who helped contribute to this important milestone, and we remain committed to bringing medicines to patients with unmet medical needs for debilitating neurological disorders."
- In clinical studies in Huntington's disease, treatment-emergent adverse events included somnolence and sedation, urticaria, rash and insomnia.
- "Data also demonstrated INGREZZA was generally well tolerated and showed clinically meaningful improvement in adults with chorea associated with HD."
- "The approval of INGREZZA for HD chorea means that people living with HD have a new treatment option to help manage their chorea symptoms, which is a welcomed milestone in efforts to improve care for families affected by HD."
