AUSTEDO XR EXTENDED-RELEASE TABLETS AND AUSTEDO TABLETS


Associated tags: Tardive dyskinesia, Safety, Patient, Food, Chorea, VMAT2, Health, Doctor of Philosophy, Pharmaceutical, Biotechnology, FDA, TASE, NYSE, Teva Pharmaceuticals, Medication, Teva, TEVA, Neurology, TD, HD, MD, Clinical Trials

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: 
Wednesday, May 29, 2024

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 .

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: 
Tuesday, April 16, 2024

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 to Present New Data Supporting Safety, Efficacy and Real-World Effectiveness of AUSTEDO® (deutetrabenazine) Tablets at the 2023 HSG Annual Meeting

Retrieved on: 
Thursday, November 2, 2023

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new HD data will be presented at the Huntington Study Group® (HSG) Annual Meeting on November 2-4 in Phoenix, AZ.

Key Points: 
  • Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new HD data will be presented at the Huntington Study Group® (HSG) Annual Meeting on November 2-4 in Phoenix, AZ.
  • TMC scores mostly improved with AUSTEDO treatment, and the safety profile was consistent with AUSTEDO’s known safety profile.
  • NNTs for treatment success based on CGIC and PGIC ranged from 3-4 and 4-5, respectively, for the VMAT2 inhibitors.
  • Significant NNHs included:
    Together, the data provide additional insight into the real-world efficacy and safety of AUSTEDO for patients with HD chorea.

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: 
Wednesday, September 6, 2023

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.

Teva Presents Real-World Data for AUSTEDO® (deutetrabenazine) Tablets with 4-Week Patient Titration Kit at Psych Congress Elevate 2023

Retrieved on: 
Friday, June 2, 2023

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced 12 presentations across its neuroscience portfolio featured at the Psych Congress Elevate 2023 Annual Meeting taking place on June 1-4, 2023.

Key Points: 
  • Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced 12 presentations across its neuroscience portfolio featured at the Psych Congress Elevate 2023 Annual Meeting taking place on June 1-4, 2023.
  • Two presentations feature real-world data for AUSTEDO (deutetrabenazine) tablets for adults living with TD.
  • Data presented will include interim findings from the START trial, a Phase 4 study investigating real-world utilization of AUSTEDO with a 4-week patient titration kit along with treatment success as measured at the end of treatment.
  • Teva will also present findings from studies evaluating potential drug-drug interactions with VMAT2 inhibitors, as well as patient and healthcare provider perspectives on the impact of TD.

AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets, New Once-Daily Formulation of AUSTEDO®, Now Available in the U.S.

Retrieved on: 
Monday, May 15, 2023

AUSTEDO XR was recently approved by the U.S. Food and Drug Administration (FDA) for adults living with tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD).

Key Points: 
  • AUSTEDO XR was recently approved by the U.S. Food and Drug Administration (FDA) for adults living with tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD).
  • “The twice-daily formulation will also remain available so that patients may have a choice for what works best for them.
  • Once-daily AUSTEDO XR has been shown to be therapeutically equivalent to the twice-daily formulation – offering a new and effective treatment choice.1 AUSTEDO XR may also result in a decreased pill count for patients compared to the twice-daily AUSTEDO.
  • For more information regarding cost and coverage options for AUSTEDO XR through Teva Shared Solutions, visit MySharedSolutions.com .

Teva to Present New Data on Once-Daily AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets at the 2023 American Academy of Neurology Annual Meeting

Retrieved on: 
Tuesday, April 11, 2023

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced six poster abstracts across its neurology portfolio will be presented at the American Academy of Neurology (AAN) Annual Meeting on April 22-27, 2023.

Key Points: 
  • Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced six poster abstracts across its neurology portfolio will be presented at the American Academy of Neurology (AAN) Annual Meeting on April 22-27, 2023.
  • Abstracts include data for AUSTEDO (deutetrabenazine) tablets, as well as once-daily AUSTEDO XR (deutetrabenazine) extended-release tablets.
  • Bioequivalence and relative bioavailability were established between the once-daily and twice-daily tablet formulations, with no new safety findings emerging.
  • Teva will also present real-world data showing people living with HD chorea who are taking antipsychotic medications with twice-daily AUSTEDO experienced improved motor signs.

Teva Announces FDA Approval of AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets, a New Once-Daily Formulation of AUSTEDO® (deutetrabenazine) Tablets

Retrieved on: 
Friday, February 17, 2023

AUSTEDO XR is an additional formulation of the currently marketed twice-daily AUSTEDO.

Key Points: 
  • AUSTEDO XR is an additional formulation of the currently marketed twice-daily AUSTEDO.
  • “The approval of AUSTEDO XR is a reflection of our ongoing innovation for people living with TD and HD chorea,” said Eric Hughes, MD, PhD, Executive Vice President of R&D and Chief Medical Officer at Teva.
  • “Today’s approval marks an exciting milestone for patients with TD and HD chorea,” said Sven Dethlefs, PhD, Executive Vice President, North America Commercial at Teva.
  • AUSTEDO XR is expected to be available in the U.S. later this year.