Chorea

Teva Announces AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets Now U.S. FDA Approved as a One Pill, Once-Daily Treatment Option for Clinically Therapeutic Doses (24–48 mg/day)

Retrieved on: 
水曜日, 5月 29, 2024
Research, Mental Health, Neurology, FDA, Clinical Trials, Biotechnology, Managed Care, Pharmaceutical, Health, Science, Insurance, Chorea, Patient, Eating, TMC, Food, HD, Medication, TEVA, Walking, VMAT2, DSM-IV codes, Senior, Behavior, Teva, Teva Pharmaceuticals, Pharmaceutical industry

Innovative Medicines at Teva.

Key Points: 
  • Innovative Medicines at Teva.
  • “AUSTEDO, backed by the longest efficacy and tolerability data to date, has continued to evolve – having received approval for AUSTEDO XR, our once-daily extended-release formulation in February 2023.
  • Savings on out-of-pocket costs may vary depending on the patient’s insurance provider and eligibility for participation in the co-pay assistance program.
  • For more information regarding cost and coverage options for AUSTEDO XR through Teva Shared Solutions, visit MySharedSolutions.com .

Neurocrine Biosciences Announces U.S. FDA Approval of INGREZZA® SPRINKLE (valbenazine) Capsules

Retrieved on: 
火曜日, 4月 30, 2024
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.

Teva’s New Real-World Evidence Presented at the 2024 AAN Annual Meeting Confirms Effectiveness and Patient Satisfaction for HD Chorea with the 4-week Titration Kit for AUSTEDO® (deutetrabenazine) Tablets

Retrieved on: 
火曜日, 4月 16, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Neurodegenerative disease, American Academy, TMC, Safety, Education, Teva, TEVA, MD, Doctor of Philosophy, START, HD, Psychiatry, Patient, AAN, Eating, Medication, Teva Pharmaceuticals, Chorea

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced final results from the HD cohort of the Phase 4 START study, demonstrating positive real-world effectiveness, safety, adherence and satisfaction with the 4-week Titration Kit for AUSTEDO.

Key Points: 
  • Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced final results from the HD cohort of the Phase 4 START study, demonstrating positive real-world effectiveness, safety, adherence and satisfaction with the 4-week Titration Kit for AUSTEDO.
  • As a fatal, neurodegenerative disease, HD can cause cognitive deterioration, behavioral and/or psychological problems and uncontrollable body movements known as chorea – a symptom that can have a significant impact on daily activities like eating or talking.3-5 These data are being presented at the 2024 American Academy of Neurology (AAN) Annual Meeting.
  • “90% of HD patients experience chorea,3,4 so it’s important for patients to have a treatment option that not only helps address symptoms, but helps provide a positive patient experience,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva.
  • “I’m glad to see this outcome as it gives clinicians more confidence and patients more control.”

Teva and Jiangsu Nhwa Forge Strategic Partnership to Promote Patient Access to AUSTEDO® in China

Retrieved on: 
月曜日, 2月 26, 2024
FDA, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Tardive dyskinesia, Chorea, VMAT2, Metabolism, EVP, Deuterium, Annual report, TEVA, Marketing, Teva, Partnership, HD, Quality of life, Food, Schizophrenia, Neurological disorder, DSM-IV codes, Globalization, Neuro, Prevalence, Happy Mood, Face, Anesthesia, Central nervous system disease, Pivot, Tongue, CNS, Psychiatry, Patient, Pain, Disease, Extremities, Research, Pharmaceutical industry

The partnership intends to increase patients’ access to Teva’s AUSTEDO, leveraging Nhwa’s leadership in China’s neuro-psychiatric health sector.

Key Points: 
  • The partnership intends to increase patients’ access to Teva’s AUSTEDO, leveraging Nhwa’s leadership in China’s neuro-psychiatric health sector.
  • “Nhwa has deep neuro-psychiatry expertise and capabilities, from research and development to commercialization,” commented Theodor Wee, General Manager of Teva Greater China.
  • Chorea, one of the most striking physical manifestations of Huntington’s disease, is a neurological disorder that causes involuntary, random muscle movements.
  • Jiangsu Nhwa Pharmaceutical Co., Ltd., founded in 1978, is a leading CNS company in China.

US Neurologists Optimistic Regarding the Huntington’s Disease Treatment Pipeline, Emphasizing Halting Neurodegeneration as Leading Treatment Priority

Retrieved on: 
水曜日, 1月 3, 2024
Movement, Family, Caudate nucleus, PTC, SOM, Disease, Chorea, Frustration, Brain, Research, HD, Therapy, Tardive dyskinesia, Neurology, Dementia, Huntingtin, Atrophy, Pathology, PTC Therapeutics, Optimism, Patient, Movement disorder, Neuron, Pharmaceutical industry

Thus, often without full awareness, patients lose motor control, experience psychiatric symptoms, and cognitive decline.

Key Points: 
  • Thus, often without full awareness, patients lose motor control, experience psychiatric symptoms, and cognitive decline.
  • A neurologist’s perspective from a recent research study suggests:
    “A Huntington’s patient is almost a combination of Alzheimer’s, tardive dyskinesia, Parkinson’s - all in one.
  • Recognizing the significant treatment unmet needs, Spherix Global Insights conducted a market landscape study, seeking insights from neurologists managing HD.
  • Additionally and unaided, neurologists also mentioned Annexon Biosciences’ ANX005, Azevan Pharmaceuticals’ SRX246, SOM Biotech’s SOM3355, and Vaccinex, Inc.’s pepinemab.

Neurocrine Biosciences® Presents INGREZZA® (valbenazine) Capsules Interim Data Demonstrating Sustained Improvements in Chorea Associated With Huntington's Disease Through Week 50 at Huntington Study Group 2023

Retrieved on: 
木曜日, 11月 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.

Teva to Present Data for AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets, AUSTEDO® (deutetrabenazine) Tablets and UZEDY™ (risperidone) Extended-Release Injectable Suspension at Psych Congress 2023

Retrieved on: 
水曜日, 9月 6, 2023
Science, Neurology, Biotechnology, Research, Pharmaceutical, Health, Mental Health, Clinical Trials, Teva Pharmaceuticals, HD, Abstract (summary), LAI, Risk, Different Stages, TEVA, Global R&D management, Olanzapine, Teva, De novo, TD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Lais, Doctor of Philosophy, Medication, Depression, Risperidone, Poster, Migraine, MD, Treatment, TASE, Post hoc analysis, Chorea, Reactions on surfaces, FDA, Mental health, NYSE, Tardive dyskinesia, Food, Pharmaceutical industry, Patient, Schizophrenia

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced 16 data presentations across its neuroscience portfolio happening at Psych Congress on September 6-10 in Nashville, TN.

Key Points: 
  • Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced 16 data presentations across its neuroscience portfolio happening at Psych Congress on September 6-10 in Nashville, TN.
  • Abstracts include data for AUSTEDO, once-daily AUSTEDO XR, UZEDY, TV-44749 and AJOVY.
  • Once-daily AUSTEDO XR, a new formulation of twice-daily AUSTEDO was approved by the U.S. Food and Drug administration (FDA) in February 2023 for adults with TD and chorea associated with Huntington’s disease (HD), and UZEDY, a long-acting formulation of risperidone for subcutaneous use, was approved by the FDA in April 2023 for adults with schizophrenia.1,2 TV-44749 is an investigational formulation of olanzapine currently being studied in adults with schizophrenia.3
    “Because of the immense impact that mental health and neurological conditions like schizophrenia, TD and HD pose for patients, we are constantly striving to advance research that can enhance available treatment options,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva.
  • “Following this year’s FDA approval of once-daily AUSTEDO XR and UZEDY and the excitement they have received from the medical community, we are thrilled to continue to share research showcasing their potential for patients living with these debilitating conditions.”
    In addition to these data presentations, Teva will also be hosting a symposium to discuss results of the DECIDE study, highlighting perspectives from U.S. psychiatric clinicians on selecting and initiating LAI antipsychotics as well as the real-world barriers that cause LAIs to remain underutilized in clinical practice.

Neurocrine Biosciences Presents New INGREZZA® (valbenazine) Capsules Data Demonstrating Early and Sustained Improvements in Chorea Associated With Huntington's Disease

Retrieved on: 
月曜日, 8月 28, 2023
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:

Neurocrine Biosciences Announces FDA Approval of INGREZZA® (valbenazine) Capsules for the Treatment of Chorea Associated With Huntington's Disease

Retrieved on: 
金曜日, 8月 18, 2023
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."

SciSparc and Clearmind Collaboration Continues to Increase its Patent Portfolio in the Field of Movement Abnormalities in the U.S.

Retrieved on: 
火曜日, 8月 1, 2023
Patent, Extremities, CSE, Central nervous system, Therapy, Tic disorder, Face, United States Patent and Trademark Office, DSM-IV codes, Tourette syndrome, Dystonia, FSE, IP, TEL, Disorder, Parkinson's disease, CWY, Chorea, Pharmaceutical industry, Dyskinesia

The provisional patent application was filed with the United States Patent and Trademark Office.

Key Points: 
  • The provisional patent application was filed with the United States Patent and Trademark Office.
  • This patent application refers to combination of the psychedelic molecule 3-Methylmethcathinone, known as 3-MMC, and SciSparc's Palmitoylethanolamide as a potential treatment for dyskinesia.
  • This patent prospect corresponds well with SciSparc’s robust IP portfolio and some of the indications the Company is already pursuing such as Tourette Syndrome.
  • Our collaboration with Clearmind continues to bear fruit and emphasizes our commitment to pioneering innovative treatments for conditions with unmet need,” stated SciSparc’s Chief Executive Officer, Oz Adler.