Austedo (deutetrabenazine) / Teva - LARVOL DELTA

Refractory tardive dyskinesia in the critical care setting: A case report of successful use of phenobarbital. (PubMed, SAGE Open Med Case Rep) - "Despite withdrawal of antipsychotics, a trial of deutetrabenazine, and high-dose tetrabenazine (150 mg/day for several weeks), symptoms persisted and significantly impaired critical care management. Given phenobarbital's activity on Gamma Aminobutyric Acid B receptors, its mechanism may involve modulation of GABAergic pathways implicated in the pathophysiology of tardive dyskinesia. Further investigation in clinical studies is warranted."

Journal • CNS Disorders • Critical care • Movement Disorders • Psychiatry • Schizophrenia

Medicare announces price cuts for…prescription drugs… (MSN News) - "Here are the negotiated prices for the drugs, based on a 30-day supply, compared to the 2024 list price:...(i) Otezla, a psoriatic arthritis drug: $1,650, down from $4,722...; (ii) Austedo and Austedo XR, for Huntington’s disease: $4,093, down from $6,623."

Commercial • Huntington's Disease • Psoriatic Arthritis

Exploring the Healthcare Resource Utilization (HCRU) Associated With Chorea in Patients With Huntington's Disease (HD): A Systematic Literature Review (SLR) (ISPOR-EU 2025) - "Risperidone was the most prescribed (26%), tetrabenazine (17%), other (6%), risperidone + tetrabenazine (6%), and deutetrabenazine (2%). Chorea imposes a substantial HCRU burden on patients with HD, which increases with chorea severity. Chorea imposes a substantial HCRU burden on patients with HD, which increases with chorea severity. Patients with the most severe chorea require more healthcare resources and experience greater impairments in work/daily functioning. Despite VMAT2 inhibitors being the only approved treatments for chorea in HD, their use remains limited—potentially due to costs."

Clinical • HEOR • Review • CNS Disorders • Huntington's Disease • Movement Disorders • Psychiatry

AUSTEDO – shows continued strong growth with global revenues of $618 million in Q3 2025 (+38% in LC YoY); led by U.S. revenue growth (+38% YoY). Increasing AUSTEDO 2025 revenue outlook by $50 million - $100 million to a new range of $2,050 million - $2,150 million. (Teva Press Release)

Sales • Huntington's Disease

Update on Pharmacology in Tourette's Disorder (AACAP 2025) - "There are only 3 pharmacological interventions FDA-approved for TD: pimozide, haloperidol, and aripiprazole, and as such, most treatments are used off-label...She will also describe recent trials that did not meet their primary end points (eg, deutetrabenazine, nabiximols), but may still hold promise for certain individuals/subgroups with TD... There is a great need for new medications for TD that are as effective for tics as antipsychotics, but without the potential short and long-term side effects associated with typical and atypical antipsychotics. Recently, new medications currently in Phase IIb and III trials are showing great promise!.TD, TICD, PPC"

CNS Disorders • Mental Retardation • Movement Disorders • Psychiatry • Tourette Syndrome

Impact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington Disease (clinicaltrials.gov) - P2/3 | N=30 | Enrolling by invitation | Sponsor: Vanderbilt University Medical Center | Recruiting ➔ Enrolling by invitation | Trial primary completion date: Aug 2025 ➔ Dec 2025

Enrollment status • Trial primary completion date • Genetic Disorders • Huntington's Disease • Movement Disorders

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 October 2025 (European Medicines Agency) - "Following a re-examination at the request of the applicant for Austedo (deutetrabenazine), a medicine for the treatment of adults with moderate-to-severe tardive dyskinesia, the committee confirmed its initial recommendation to not consider deutetrabenazine, as a new active substance."

European regulatory • CNS Disorders

Scopolamine-induced Tardive Dyskinesia: A Case Report (MDS Congress 2025) - "He was then prescribed fluphenazine and deutetrabenazine for the diagnosis of tics and experienced drug-induced parkinsonism as a side effect with the onset of shuffling gait and right upper extremity rest tremor...He was started on valbenazine with significant improvement in his TD and minimal side effects of parkinsonism at the 60mg daily dosage. Although exacerbation of TD by anticholinergics is well documented in the literature, there are few cases of anticholinergic-associated TD documented. Further investigation is essential to determine the interplay between the cholinergic and dopaminergic systems, given the frequent use of anticholinergic medications for common disorders, including nausea, COPD, urinary frequency, and asthma."

Case report • Clinical • CNS Disorders • Epilepsy • Movement Disorders • Parkinson's Disease

Real-World Effectiveness of the 4-Week Patient Deutetrabenazine-Titration Kit for Tardive Dyskinesia Across Races: START Study Post Hoc Analysis (MDS Congress 2025) - "In the START study, patients of all included races showed improvements in AIMS, CGIC, and PGIC scores, and achieved DTBZ doses ≥24 mg. Regardless of race, the DTBZ 4-week titration kit enabled patients to achieve therapeutic doses and effectiveness of DTBZ similar to clinical trials."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Retrospective data • CNS Disorders • Movement Disorders

Real-World Experiences with VMAT2 Inhibitors in Pediatric Hyperkinetic Movement Disorders (MDS Congress 2025) - "Our study suggests that VMAT2 inhibitors are effective for treating pediatric hyperkinetic movement disorders. While adverse effects were common, most were mild and improved with dosage reduction or transitioning to deutetrabenazine or valbenazine. Furthermore, this study provides insights into barriers to access to these drugs by pediatric patients."

Clinical • Real-world • Real-world evidence • CNS Disorders • Movement Disorders

Comparative Efficacy and Safety of VMAT2 Inhibitors for Chorea in Huntington's Disease: A Systematic Review and Meta-Analysis (MDS Congress 2025) - "Objective: To assess the safety and efficacy of vesicular monoamine transporter 2 (VMAT2) inhibitors (deutetrabenazine, tetrabenazine, valbenazine) in managing chorea in Huntington's Disease (HD). VMAT inhibitors effectively enhance chorea motor symptoms in HD, with notable CGI-C improvement. safety is considered acceptable, with fatigue being the most common side effect, but not significantly more prominent than placebo. Regardless of the restricted number of RCTs, this meta-analysis shows strong comparative evidence regarding VMAT2 inhibitors data available in the literature."

Retrospective data • Review • CNS Disorders • Movement Disorders

Efficacy and Safety of Deutetrabenazine in Huntington's Disease: a Systematic Review (MDS Congress 2025) - "DTB demonstrates to be safe and effective in reducing chorea in HD. Conversion from TBZ to DTB is effective and well-tolerated. These findings support DTB as a viable treatment option, although long-term studies are needed to confirm its benefits and safety over longer periods."

Clinical • Review • CNS Disorders • Depression • Insomnia • Mood Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • Sleep Disorder

Adult-Onset Post-Pump Chorea: A Rare Manifestation Post-Cardiac Surgery in a Puerto Rican Patient (MDS Congress 2025) - "Patient was successfully treated with deutetrabenazine for involuntary movements, but later developed a neurocognitive disorder. This case presents a rare occurrence of late-onset post-pump chorea (PPC) in an elderly adult, emerging two months after CPB surgery. We propose the patient's chorea resulted from the combination of his vascular risk factors, CPB surgery, and prolonged ICU stay."

Clinical • Surgery • CNS Disorders • Cognitive Disorders • Movement Disorders

Efficacy and safety of vesicular monoamine transporter 2 inhibitors for Huntington's disease chorea based on network meta-analysis. (PubMed, Front Pharmacol) - "Three VMAT2 inhibitors, including tetrabenazine, deutetrabenazine and valbenazine were investigated. Tetrabenazine is the most effective in controlling chorea, whereas valbenazine may be the optimal choice for patients with comorbid psychiatric symptoms. https://www.crd.york.ac.uk/PROSPERO/view/CRD420251012431, identifier CRD420251012431."

Journal • Retrospective data • Review • Huntington's Disease • Movement Disorders • Psychiatry • Suicidal Ideation

Not the moves you asked for: exploring dopamine receptor-blocking agents-induced movement disorders (ECNP 2025) - "Treatment involves anticholinergic agents like benztropine or diphenhydramine to rapidly alleviate symptoms...Management includes dose reduction, switching to a lower-risk agent, beta-blockers (e.g., propranolol), and benzodiazepines...Management involves reducing or discontinuing the DRBA and switching to alternatives like clozapine or quetiapine, which have a lower risk of causing parkinsonism...Treatment focuses on the use of vesicular monoamine transporter 2 (VMAT2) inhibitors, such as valbenazine and deutetrabenazine... Beyond physical symptoms, DIMDs severely impact quality of life. Unlike psychiatric symptoms, which are internal, DIMDs are highly visible, leading to social stigma, emotional distress, and functional impairment. Akathisia has been linked to dysphoria and suicidal ideation, while TD can increase mortality."

Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dystonia • Mood Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • Suicidal Ideation

Efficacy and Safety of VMAT-2 Inhibitors and Dopamine Stabilizers for Huntington's Chorea: A Systematic Review, Meta-Analysis, and Trial Sequential Analysis. (PubMed, Med Sci (Basel)) - "VMAT-2 inhibitors may suggest potential improvements in motor symptoms in Huntington's disease, while current evidence does not demonstrate a significant benefit of dopamine stabilizers. The safety profiles of both treatments appear generally comparable to placebo. Further rigorous and long-term studies are required to better establish their efficacy and safety."

Clinical • Journal • Retrospective data • Review • Genetic Disorders • Huntington's Disease • Movement Disorders

A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor (clinicaltrials.gov) - P4 | N=50 | Recruiting | Sponsor: Neurocrine Biosciences | Not yet recruiting ➔ Recruiting

Enrollment open • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Movement Disorders • Psychiatry • Schizophrenia

Selected drugs, therapeutic alternatives, and price benchmarks for IPAY 2027 Medicare drug price negotiation. (PubMed, J Manag Care Spec Pharm) - "Four drugs were identified to have 1 (deutetrabenazine, linaclotide, and nintedanib-esylate) or no (rifaximin) therapeutic alternative...Four products (acalabrutinib, semaglutide, linagliptin, and sitagliptin/metformin) will include therapeutic alternatives and MFPs from the first round of negotiation...These analyses identify the likely ceiling price and various initial price offer scenarios for the second round of Medicare price negotiation. We report price benchmarks and likely therapeutic alternatives to improve transparency around the opaque CMS negotiation process."

Journal • Medicare • Reimbursement • US reimbursement

New Developments in the Treatments of Psychosis (WFSBP 2025) - "Objective: Despite the discovery of chlorpromazine over 70 years ago and substantial pharmacologic advances, postsynaptic dopamine blockade has remained the sole mechanism of action of approved drugs for schizophrenia... Newly/recently approved agents include vesicular monoamine transporter-2 inhibitors valbenazine and deutetrabenazine for tardive dyskinesia and, possibly, residual positive symptoms; olanzapine/samidorphan combination, lumateperone, new formulations, including subcutaneous injections, and ultra-long-acting injectable antipsychotics. Agents in development that have at least one positive phase 1B, 2 or 3 trial include the trace amine-associated receptor-1 (TAAR1) ulotaront, M1/M4 muscarinic agonist xanomeline plus peripherally restricted anticholinergic trospium, the M4 muscarinic positive allosteric modulator emraclidine, as well as multiple other muscarinic receptor modulators for total psychopathology, methylated amisulpride (LB-102), and evenamide, a..."

CNS Disorders • Movement Disorders • Psychiatry • Schizophrenia

A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor (clinicaltrials.gov) - P4 | N=50 | Not yet recruiting | Sponsor: Neurocrine Biosciences

New P4 trial • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Movement Disorders • Psychiatry • Schizophrenia

Vesicular monoamine transport inhibitors: current uses and future directions. (PubMed, Lancet) - "VMAT2 inhibitors, such as tetrabenazine, deutetrabenazine, and valbenazine, show therapeutic efficacy in managing hyperkinetic movement disorders, including Huntington's disease, tardive dyskinesia, and Tourette's syndrome. Recent studies have provided further structural insights into VMAT2 inhibition mechanisms, paving the way for the development of inhibitors with enhanced potency and selectivity. Leveraging pharmacogenetics for precision medicine and exploring VMAT2 inhibition in broader therapeutic contexts could revolutionise treatment frameworks for neurological and psychiatric conditions."

Journal • Review • CNS Disorders • Huntington's Disease • Mental Retardation • Movement Disorders • Psychiatry • Tourette Syndrome

Teva’s Innovative Portfolio Fuels 10th Consecutive Quarter of Growth in Q2 2025; Increases 2025 Revenue Outlook for Key Innovative Products and EPS, and Reaffirms All Other Components (GlobeNewswire) - "AJOVY revenues in our United States segment in the second quarter of 2025 were $63 million, an increase of 53% compared to the second quarter of 2024, mainly due to an increase in sales allowance due to a non-recurring item in the second quarter of 2024 and growth in volume in the second quarter of 2025....AUSTEDO revenues in our United States segment in the second quarter of 2025 were $495 million, an increase of 22%, compared to $407 million in the second quarter of 2024....UZEDY (risperidone) extended-release injectable suspension revenues in our United States segment in the second quarter of 2025 were $54 million, an increase of 120% compared to the second quarter of 2024, mainly due to growth in volume....COPAXONE revenues in our United States segment in the second quarter of 2025 were $62 million, a decrease of 23% compared to the second quarter of 2024, mainly due to market share erosion and competition."

Sales • Huntington's Disease • Migraine • Multiple Sclerosis • Schizophrenia

Real-World Experiences with VMAT2 Inhibitors in Pediatric Hyperkinetic Movement Disorders. (PubMed, Tremor Other Hyperkinet Mov (N Y)) - "Of the 359 prescriptions for VMAT2 inhibitors, 94% included tetrabenazine, 4.6% deutetrabenazine, and 1.4% valbenazine. Our study suggests that VMAT2 inhibitors are effective for treating pediatric hyperkinetic movement disorders. Furthermore, this study provides insights into barriers to access to these drugs by pediatric patients."

Journal • Real-world evidence • Huntington's Disease • Movement Disorders • Pediatrics

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 June 2025 (European Medicines Agency) - "On 19 June 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Austedo, intended for the treatment of adults with moderate to severe tardive dyskinesia. The applicant for this medicinal product is TEVA GmbH. Austedo will be available as 12 mg, 24 mg, 30 mg, 36 mg, 42 mg and 48 mg prolonged-release tablets."

CHMP • CNS Disorders

A narrative review of Phase III and IV clinical trials for the pharmacological treatment of Tourette's syndrome in children, adults, and older adults. (PubMed, Medicine (Baltimore)) - "Deutetrabenazine (TEV-50717) showed limited efficacy compared to placebo. Other medications, including Clonidine, Guanfacine, Levetiracetam, Ondansetron, Topiramate, D-serine, and Riluzole, demonstrated varying levels of effectiveness, though some require further validation...Aripiprazole stands out as the most effective therapy, though further research is needed for other medications. Continued advancements in pharmacological interventions offer promise for improving the management of TS and enhancing the quality of life for affected individuals."

Journal • P3 data • Review • CNS Disorders • Developmental Disorders • Movement Disorders • Psychiatry • Tourette Syndrome