Uzedy (risperidone XR SC suspension) / Teva, MedinCell - LARVOL DELTA

Population Pharmacokinetic-Based Strategies for Switching Patients with Schizophrenia Between Long-Acting Injectable Formulations of Risperidone: R064766 or RBP-7000 to TV-46000. (PubMed, Neurol Ther) - "These simulations revealed switching to TV-46000 4-6 weeks after the last dose of R064766 and 4 weeks after the last dose of RBP-7000 provided generally comparable PK exposures at first dose and steady state of TV-46000. Clinician discretion will determine which switching strategy is most appropriate in context based on factors such as patient preference, scheduling convenience, and concerns about tolerability."

Journal • PK/PD data • CNS Disorders • Psychiatry • Schizophrenia

FDA Approves Expanded Indication for UZEDY (risperidone) Extended-Release Injectable Suspension as a Treatment for Adults Living with Bipolar I Disorder (Teva Press Release) - "The approval is based on existing clinical data for UZEDY, coupled with Model-Informed Drug Development (MIDD) methodologies that leverage previous findings on the safety and efficacy of risperidone formulations already approved for BD-I."

FDA approval • Bipolar Disorder

In a retrospective observational cohort study that included HCPs who prescribed UZEDY or Invega Sustenna (paliperidone palmitate) for patients with schizophrenia during hospitalization, found that the initiation of UZEDY (n=137) was associated with shorter hospital stays compared to Invega Sustenna (n=94) (Teva Press Release) - "UZEDY was associated with a 2.89-day shorter length of stay compared with Invega Sustenna (12.57 [SD:10.03] vs 15.46 days [10.15], P=0.033), which translates to estimated direct cost savings of $3,200 per hospitalization. UZEDY was favored over Invega Sustenna for ease of administration (45% vs 34%), initiation (47% vs 33%), dosing characteristics (40% vs 38%), and subcutaneous injection features (40% vs 33%). Overall, 45% preferred UZEDY, while 38% preferred Invega Sustenna."

Retrospective data • Schizophrenia

Uzedy, long-acting subcutaneous injection for schizophrenia, wins Korean approval (Korea Biomedical Review)

Korea approval • Schizophrenia

Switching Patients with Schizophrenia from Intramuscular Paliperidone Palmitate Once Monthly to TV-46000, a Long-Acting Subcutaneous Antipsychotic: Population Pharmacokinetic-Based Strategies. (PubMed, Adv Ther) - "Switching to TV-46000 125 mg q1m 4 weeks after the last PP1m 234-mg injection yielded generally comparable pharmacokinetic parameters at steady state. The same was true for other TV-46000 q1m or q2m dosages and equivalent dosages of PP1m. Clinician discretion will ultimately determine how to switch on the basis of factors such as patient preference, convenience, and concerns about tolerability or symptom breakthrough."

Journal • PK/PD data • CNS Disorders • Psychiatry • Schizophrenia

Safety Outcomes with the Long-Acting Subcutaneous Antipsychotic TV-46000 in Schizophrenia: A Post Hoc Analysis of Behavioral, Neuromotor, Endocrine, and Cardiometabolic Outcomes from Two Phase 3 Studies. (PubMed, CNS Drugs) - P3 | "The safety profile of TV-46000 is favorable and consistent with other currently approved oral and long-acting injectable risperidone formulations."

Journal • P3 data • Retrospective data • Cardiovascular • CNS Disorders • Depression • Diabetes • Endocrine Cancer • Insomnia • Mood Disorders • Pain • Psychiatry • Schizophrenia • Sleep Disorder

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

Efficacy and Safety of TV-46000 and Second-Generation Long-Acting Injectable Antipsychotics for Schizophrenia: A Systematic Literature Review and Network Meta-Analysis of Randomized Controlled Trials. (PubMed, Adv Ther) - "TV-46000 q1m and q2m demonstrated comparable efficacy and safety to second-generation LAIs approved in Canada and used for maintenance treatment of schizophrenia."

Clinical • Journal • Retrospective data • Review • CNS Disorders • Pain • Psychiatry • Schizophrenia

Clinical Utility of Long-Acting Injectable Risperidone in Schizophrenia and Bipolar I Disorder: A Review of Clinical Studies. (PubMed, Psychol Res Behav Manag) - "To date, five different risperidone LAI formulations have been marketed - including a second biweekly microsphere injection (LY03004), a newer monthly intramuscular formulation using in situ microparticles (ISM) technology that does not require an oral risperidone run-in, and two subcutaneous formulations (RBP-7000 and TV-46000)...To facilitate this, healthcare providers should develop a comprehensive understanding of these formulations to select the most suitable option. While risperidone ISM, RBP-7000, and TV-46000 may enhance treatment feasibility and adherence, further research is needed to build an evidence base comparable to that available for BW-RLAI, particularly in the treatment of BD."

Journal • Review • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry • Schizophrenia

Teva Reports Ninth Consecutive Quarter of Growth in Q1 2025 With Key Innovative Medicines Growing ~40%; 2025 Profit Outlook Improved (Teva Press Release) - "AUSTEDO – shows continued strong growth, with worldwide revenues of $411 million in Q1 2025, an increase of 39% in local currency terms compared to Q1 2024; increasing 2025 full-year revenue outlook from ~$1.9-2.05 billion to $1.95-2.05 billion. AJOVY – global revenues of $139 million in Q1 2025, an increase of 26% in local currency terms compared to Q1 2024. Reaffirming $600M 2025 revenue outlook. UZEDY continues strong momentum – global revenues of $39 million in Q1 2025."

Sales • CNS Disorders • Huntington's Disease • Migraine • Schizophrenia

New Data Strengthens Teva’s Schizophrenia Portfolio... (GlobeNewswire) - "Below is the full set of schizophrenia data presented by Teva at SIRS 2025: TEV-'749 (olanzapine): (De novo) Patient and healthcare professional attitudes and trial experiences with a subcutaneous long-acting injectable olanzapine (TV-44749) for the treatment of schizophrenia; UZEDY (risperidone): (De novo) Predictors of response and non-response to treatment for schizophrenia: machine learning analysis of patients treated with TV-46000 or placebo in the RISE study; Schizophrenia Treatment Landscape: (De novo) Healthcare professionals’ attitudes toward use of long-acting injectable antipsychotics for schizophrenia treatment differ among settings of care: ADVANCE survey results; (De novo) The evolving schizophrenia treatment landscape in the United States: A real-world claims analysis of treatment patterns and use of long-acting injectable antipsychotics; (De novo) Real-world antipsychotic prescription patterns among patients with schizophrenia in Australia:..."

Clinical data • Schizophrenia

Population Pharmacokinetic Modeling of TV-46000, a Risperidone Long-Acting Subcutaneous Antipsychotic for the Treatment of Patients with Schizophrenia. (PubMed, Neurol Ther) - "The developed popPK model, together with corresponding simulations, supports TV-46000 as a LASCA that offers flexible dosing intervals (q1m or q2m) and administration sites (abdomen or upper arm) and does not require oral supplementation or loading dose(s)."

Journal • PK/PD data • CNS Disorders • Psychiatry • Schizophrenia

An Evaluation of the Subcutaneous Depot Release of TV-46000, A Novel Long-Acting Injectable (LAI) Formulation of Risperidone, Under Extreme Conditions in Dogs, Minipigs and Humans. (PubMed, Pharmaceutics) - "The observed similarity in findings between the animal and human studies supports the suitability of animal models for evaluation of the effect of extrinsic factors on injection sites and its translatability to clinical settings."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Teva and Medincell Announce FDA Acceptance of Supplemental New Drug Application for UZEDY (risperidone) Extended-Release Injectable Suspension as a Treatment for Patients with Bipolar I Disorder (GlobeNewswire) - "Teva Pharmaceuticals...and Medincell...announced today that the supplemental New Drug Application (sNDA) for UZEDY extended-release injectable suspension for the maintenance treatment of BP-I in adults has been accepted for filing by the U.S. Food and Drug Administration (FDA). The sNDA is based on leveraging the existing clinical data for UZEDY coupled with the Agency’s previous findings of safety and efficacy of past risperidone formulations approved for the treatment of BP-I."

FDA filing • Bipolar Disorder

Teva Delivers Second Consecutive Year of Growth; Announces Strong Financial Results in Fourth Quarter and Full Year 2024, Led by Generics Performance and Innovative Portfolio Growth (GlobeNewswire) - "Duvakitug (Anti-TL1A) positive Phase 2B results announced and initiation of Phase 3 program is expected in 2025...AJOVY revenues in our United States segment in the fourth quarter of 2024 were $63 million, an increase of 11% compared to the fourth quarter of 2023...AUSTEDO revenues in our United States segment in the fourth quarter of 2024 increased by 27%, to $518 million, compared to $408 million in the fourth quarter of 2023...UZEDY (risperidone) extended-release injectable suspension revenues in our United States segment in the fourth quarter of 2024 were $43 million...COPAXONE revenues in our United States segment in the fourth quarter of 2024 were $63 million, a decrease of 13% compared to the fourth quarter of 2023, mainly due to market share erosion and competition, partially offset by a reduction in sales allowance."

Commercial • New P3 trial • CNS Disorders • Crohn's disease • Huntington's Disease • Migraine • Multiple Sclerosis • Schizophrenia

TV-46000, A Long-Acting Subcutaneous Antipsychotic Agent, Demonstrated Improved Patient-Centered Outcomes in Patients with Schizophrenia. (PubMed, Neuropsychiatr Dis Treat) - P3 | "Improvements in patient-centered outcomes were observed across cohorts, with the largest improvements observed for patients who began TV-46000 during SHINE (ie, de novo and placebo rollover cohorts), while gains made during RISE were minimally improved or maintained in the TV-46000 rollover cohort, indicating the benefit of uninterrupted TV-46000 treatment. These data support the effectiveness of TV-46000 to improve patient-centered outcomes in patients with schizophrenia."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Medincell’s partner Teva provides update on pivotal clinical Phase 3 of investigational Olanzapine Long-Acting Injectable (LAI) and UZEDY commercial progress (Businesswire) - P3 | N=675 | SOLARIS (NCT05693935) | Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. | "Olanzapine LAI (mdc-TJK): No PDSS observed after completion of c.95% of the targeted injections for submission; Full phase 3 safety results on track for H2 2024. UZEDY: Reaffirming revenue guidance for 2024: c.$80 million; Exploring an additional indication for UZEDY for the treatment of Bipolar I Disorder in adults."

P3 data • Sales • CNS Disorders • Schizophrenia

Physiologically-Based Pharmacokinetic Modeling and In Vitro-In Vivo Correlation of TV-46000 (Risperidone LAI): Prediction from Dog to Human. (PubMed, Pharmaceutics) - "The resulting simulated TV-46000 PK profile in humans showed that the shape of the predicted risperidone and its active metabolite 9-OH-risperidone PK profiles was different from the observed one, thus suggesting that the TV-46000 release profile was species-dependent and cannot be directly extrapolated from dog to human. In conclusion, while level A IVIVC cannot be claimed, this work combining PBPK and IVIVC modeling represents an interesting alternative approach for complex injectable formulations where classical methods are not applicable."

Journal • PK/PD data • Preclinical • CNS Disorders • Psychiatry • Schizophrenia

A Long-Term Safety and Tolerability Study of TV-46000 for Subcutaneous Use in Patients with Schizophrenia: A Phase 3, Randomized, Double-Blinded Clinical Trial. (PubMed, CNS Drugs) - P3 | "Results from this long-term safety study add to the favorable safety profiles of TV-46000 q1m and q2m, consistent with other formulations of risperidone and previous studies with TV-46000."

Clinical • Journal • P3 data • CNS Disorders • Diabetes • Pain • Psychiatry • Schizophrenia

In brief: Three new injectable antipsychotic drugs. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry • Schizophrenia

Efficacy and safety of TV-46000, a long-acting, subcutaneous, injectable formulation of risperidone, for schizophrenia: a randomised clinical trial in the USA and Bulgaria. (PubMed, Lancet Psychiatry) - P3 | "In patients with schizophrenia, subcutaneous TV-46000 once monthly and once every 2 months significantly delayed impending relapse versus placebo. TV-46000 is an effective long-acting, subcutaneous, antipsychotic agent treatment option in adult patients with schizophrenia, with a favourable benefit-risk profile."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Teva Reports Third Quarter 2023 Financial Results and Increases Revenue Guidance (Businesswire) - "AJOVY revenues in our North America segment in the third quarter of 2023 increased by 8% to $61 million, compared to the third quarter of 2022, mainly due to growth in volume. In the third quarter of 2023, AJOVY’s exit market share in the United States in terms of total number of prescriptions was 24.9% compared to 24.7% in the third quarter of 2022. AUSTEDO revenues in our North America segment in the third quarter of 2023 increased by 30%, to $339 million, compared to $260 million in the third quarter of 2022...UZEDY (risperidone) extended-release injectable suspension was approved by the FDA on April 28, 2023 for the treatment of schizophrenia in adults, and was launched in the U.S. in May 2023....COPAXONE revenues in our North America segment in the third quarter of 2023 decreased by 2% to $103 million, compared to the third quarter of 2022..."

Sales • CNS Disorders • Huntington's Disease • Immunology • Migraine • Multiple Sclerosis • Pain • Schizophrenia

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 (Businesswire) - "Teva Pharmaceuticals...announced 16 data presentations across its neuroscience portfolio happening at Psych Congress on September 6-10 in Nashville, TN. Abstracts include data for AUSTEDO...UZEDY, TV-44749 and AJOVY. "

Clinical data • P3 data • CNS Disorders • Migraine • Pain • Schizophrenia

"MedinCell’s partner @TevaUSA announces successful launch of UZEDY™ Full PR: https://t.co/SUysO5bf10 #BetterMedicineForAll #ImpactHealth #Tevapharm" (@MedinCell)

MedinCell’s Partner Teva Announces Successful Launch of UZEDY (Businesswire) - "During today’s Q2 earnings call, Richard Francis, President and CEO of Teva, and Eric Hughes, Executive Vice President, Global R&D & Chief Medical Officer, commented the US launch of UZEDY since May 2023 and the olanzapine Long-Acting Injectable (LAI)....UZEDY, a long-acting injectable (LAI) risperidone for the treatment of schizophrenia in adults, is the first FDA-approved product based on MedinCell’s BEPO technology."

Launch US • CNS Disorders • Schizophrenia