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

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

Teva Presents Real-World Data for AUSTEDO (deutetrabenazine) Tablets with 4-Week Patient Titration Kit at Psych Congress Elevate 2023 (Teva Press Release) - "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. Results from clinical studies evaluating UZEDY and TV-44749 in schizophrenia, and the DECIDE survey will be presented at the meeting as well."

Clinical data • Clinical protocol • P3 data • CNS Disorders • Schizophrenia

Teva and MedinCell Announce FDA Approval of UZEDY (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults (Businesswire) - "Teva Pharmaceuticals...and MedinCell...announced today that the U.S. Food and Drug Administration (FDA) has approved UZEDY (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults. UZEDY is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq™....This approval is based on data from two Phase 3 trials evaluating UZEDY in patients with schizophrenia...UZEDY will be available in the U.S. in the coming weeks."

Launch US • NDA • CNS Disorders • Schizophrenia

Patient and Healthcare Professional Preferences for Characteristics of Long-Acting Injectable Antipsychotic Agents for the Treatment of Schizophrenia. (PubMed, Adv Ther) - P3 | "Patients had a range of responses, and on some issues patient and HCP preferences differed. Altogether, this suggests the importance of providing patients with a range of options and the importance of patient-HCP discussions on treatment preference for LAIs."

Journal • CNS Disorders • Psychiatry • Schizophrenia

MedinCell Publishes Its First-half 2020/2021 Financial Results (april - September 2020): Operating Expenses and Portfolio Development in Line With Expectations (Businesswire) - "November 2020 (post-closing) – Phase 3 pivotal efficacy study completed in the United States for the mdc-IRM program, an experimental long-acting subcutaneous injectable treatment of risperidone for schizophrenia. Teva Pharmaceuticals, which funds and oversees the development of the program, expects to have the trial readout during the first quarter of 2021....Progress in the regulatory development of two other antipsychotics: mdc-TJK in Phase 1 and mdc-ANG in preclinical development....The first-in-human study for the investigational long-acting injectable antipsychotic mdc-TJK has started in Q4 2019. The results of this study, expected during 2021, will inform future development."

Clinical data • P3 data • Trial completion • CNS Disorders • Schizophrenia

MedinCell Announces Fiscal Year Consolidated Results - April 2020 - March 2021 (Businesswire) - "Following the announcement of positive results for the Phase 3 trial of mdc-IRM / TV46000 (schizophrenia) in January 2021, Teva Pharmaceuticals, which is leading and funding the program, is preparing for the U.S. regulatory filing, which is expected in mid-2021....Expected by the end of 2021, the findings of the ongoing analysis of the results of the first-in-human study of mdc-TJK, the second program in partnership with Teva Pharmaceuticals, will drive future developments."

NDA • P1 data • CNS Disorders • Schizophrenia

Teva to Present Latest Research From Neurology Portfolio at the 2022 American Psychiatric Association Annual Meeting (Businesswire) - "One study explores the innovative copolymer technology of TV-46000, an extended-release injectable suspension being investigated for the treatment of schizophrenia. Teva will sponsor two educational sessions, examining how social determinants of mental health relate to neuropsychiatric disorders and on the clinical value of long-acting injectables in schizophrenia treatment....Teva Pharmaceuticals...today announced four data presentations for...TV-46000/mdc-IRM. These data will be presented at the American Psychiatric Association (APA) Annual Meeting held May 21-25, 2022 in New Orleans, Louisiana, and again virtually June 7-10, 2022."

Clinical • Educational event • Preclinical • CNS Disorders • Schizophrenia

Teva Reports Fourth Quarter and Full Year 2021 Financial Results (Businesswire) - "Looking forward to 2022...We are also excited about the expected FDA approval and launch of Risperidone LAI, an important treatment for patients suffering from schizophrenia."

Launch US • NDA • CNS Disorders • Schizophrenia

TV-46000: Launch in US for maintenance treatment of schizophrenia in H1 2023 (MedinCell) - Corporate Presentation

Launch US • CNS Disorders • Schizophrenia

TV-46000: “80.0% and 62.5% reduction in risk of relapse vs placebo for monthly and bi-monthly TV-46000, respectively”; Scizophrenia (MedinCell) - Corporate Presentation: “TV-46000 provided continued symptom improvement in patients with schizophrenia”

P3 data • CNS Disorders • Schizophrenia

Teva and MedinCell Receive Complete Response Letter for TV-46000/mdc-IRM (Businesswire) - "Teva Pharmaceuticals...announced that the U.S. Food and Drug Administration ('FDA') has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of schizophrenia....Teva is reviewing its next steps based on the letter and will work closely with FDA to address their recommendations....The application included Phase 3 data from two pivotal studies: TV46000-CNS-30072 (the RISE Study – The Risperidone Subcutaneous Extended-Release Study) and TV46000-CNS-30078 (the SHINE Study – A Study to Test if TV-46000 is Safe for Maintenance Treatment of Schizophrenia)."

FDA event • CNS Disorders • Schizophrenia

MedinCell Announces Its Full Year Financial Results - April 2021 - March 2022 (Businesswire) - "Program awaiting marketing approval: mdc-IRM Treatment of schizophrenia...Teva, which is funding and leading the development of the product, plans to resubmit the New Drug Application in H2 2022. Our partner then anticipates a six-month FDA review period following re-submission. In May 2022, Teva have started pre-clinical evaluation for an additional indication in the field of neuroscience using the mdc-IRM formulation."

NDA • Preclinical • CNS Disorders • Schizophrenia

"$TEVA Teva and MedinCell Receive Complete Response Letter for TV-46000/mdc-IRM https://t.co/afYaSAtwct" (@stock_titan)

Clinical • FDA event

Population Pharmacokinetic Modeling and Simulation of TV-46000: A Long-Acting Injectable Formulation of Risperidone. (PubMed, Clin Pharmacol Drug Dev) - "The simulations showed that therapeutic dose ranges for TV-46000 are 50 to 125 mg for once-monthly and 100 to 250 mg for the once every 2 months regimens. This PPK model provided a basis for prediction of patient-specific exposure and dopamine-D2 receptor occupancy estimates to support further clinical development and dose selection for the phase 3 studies."

Journal • PK/PD data • CNS Disorders • Psychiatry • Schizophrenia • DRD2

A Study to Test if TV-46000 is Safe for Maintenance Treatment of Schizophrenia (clinicaltrials.gov) - P3; N=336; Completed; Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • CNS Disorders • Psychiatry • Schizophrenia

New Phase 3 Data Presented at Psych Congress 2021 Showed TV-46000/mdc-IRM Significantly Prolonged Time to Impending Relapse Compared to Placebo in Patients with Schizophrenia (Businesswire) - P3, N=544; RISE (NCT03503318); Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; "Results showed treatment with TV-46000 (overall, q1m or q2m) significantly prolonged time to relapse, decreased proportions of patients with impending relapse at week 24 and demonstrated significant increase in proportions maintaining stability. The safety profile of TV-46000, as demonstrated in this study, is consistent with other formulations of risperidone. The most common adverse reactions (≥5% and greater than placebo) were nasopharyngitis, increased weight, and extrapyramidal disorder. These findings...were presented during the poster session at the 2021 Psych Congress Annual Meeting taking place Oct. 29-Nov. 1, 2021..."

P3 data • CNS Disorders • Schizophrenia