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A single-centre, open-label, randomised, 2-way cross-over study to determine the effects on the short-term lower leg growth rate between Qvar® 100 µg bd delivered via a metered dose inhaler (MDI) (TEVA UK Ltd) with a reference beclometasone formulation via a reference MDI in children with mild to moderate asthma

Start Date13 Jun 2008

Sponsor / Collaborator

Teva UK Ltd.

100 Clinical Results associated with Teva UK Ltd.

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0 Patents (Medical) associated with Teva UK Ltd.

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9

Literatures (Medical) associated with Teva UK Ltd.

01 Aug 2024·CNS Drugs

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

Article

Author: Harary, Eran ; Suett, Mark ; Tohami, Orna ; Sharon, Nir ; Eshet, Roy ; Davis, Glen L ; Kane, John M ; Franzenburg, Kelli R ; Correll, Christoph U ; Knebel, Helena ; Elgart, Anna

BACKGROUNDTV-46000 is a long-acting subcutaneous antipsychotic (LASCA) formulation of risperidone that is approved by the United States Food and Drug Administration for the treatment of schizophrenia in adults. In the phase 3, randomized, double-blind RIsperidone Subcutaneous Extended-release (RISE) study, TV-46000 once monthly (q1m) and once every 2 months (q2m) significantly prolonged time to impending relapse compared with placebo [5.0-fold (q1m) and 2.7-fold (q2m)]. This phase 3, randomized, double-blind Safety in Humans of TV-46000 subcutaneous INjection Evaluation (SHINE) study was designed to evaluate the long-term safety, tolerability, and exposure of TV-46000 in schizophrenia.METHODSPatients who completed RISE without relapse (rollover) or who were newly recruited (de novo) were eligible for the SHINE study. Patients were initially stabilized on oral risperidone for 12 weeks (completed in RISE for rollover, or in SHINE for de novo). Patients in the de novo cohort and patients who received placebo in RISE were randomized 1:1 in SHINE to receive TV-46000 q1m or q2m for up to 56 weeks. Primary endpoint for SHINE was frequency of reported adverse events (AEs); event rates [ER; events per 100 patient-years (PYs)] were calculated for each AE by patients upon general questioning.RESULTSOverall, 336 patients were randomized in SHINE [TV-46000 q1m, n = 174; TV-46000 q2m, n = 162; of these, de novo, n = 109 and rollover, n = 227 (n = 172 patients were treated and n = 55 received placebo)]. A total of 334 patients were evaluated for safety [q1m, n = 172 (PY = 97.8); q2m, n = 162 (PY = 104.5)]. Proportions of patients (ER) with ≥ 1 AE and ≥ 1 treatment-related AE were 37% (180.0) and 21% (84.9) for TV-46000 q1m and 46% (157.9) and 20% (70.8) for TV-46000 q2m, respectively. Frequent treatment-related AEs [≥ 3% of patients in either group; proportion of patients (ER)] were injection site pain [q1m, 5% (24.5); q2m, 4% (22.0)] and injection site nodule [q1m, 2% (9.2); q2m, 6% (12.4)]. The proportions of patients with serious AEs was 5% for TV-46000 q1m and 7% for TV-46000 q2m; serious AEs reported for ≥ 2 patients overall were worsening schizophrenia [q1m, n = 1 (< 1%; ER, 1.02); q2m, n = 2 (1%; ER, 1.91)] and hyperglycemia [q1m, n = 1 (< 1%; ER, 1.02); q2m, n = 1 (< 1%; ER, 0.96)]. Of three reported deaths, none were related to treatment. Overall, eight patients discontinued treatment because of AEs. Similar or somewhat lower rates of AEs were reported for patients who rolled over from TV-46000 treatment compared with those who had no prior TV-46000 treatment (de novo and placebo rollover). Most AEs related to injection site reactions were mild; no patient had a severe reaction.CONCLUSIONResults 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.REGISTRATIONClinicalTrials.gov, NCT03893825; 27 March 2019.

09 Apr 2024·Neurology

A Prospective, Observational Study to Evaluate the Long-term Safety, Including Cardiovascular Safety, of Fremanezumab in Patients with Migraine in Routine Clinical Practice (P8-12.007)

Author: Krasenbaum, Lynda ; Pramod, JM ; Frain, Jill ; Campos, Verena Ramirez ; Braverman, Debra ; Kahan, Natan ; Barash, Steve ; Rainville, Carolyn ; Nellailingam, Roshini ; Akcicek, Hasan ; Jennissen, Katja ; Colilla, Susan

01 Jul 2023·International Clinical Psychopharmacology

Early versus late administration of long-acting injectable antipsychotic agents among patients with newly diagnosed schizophrenia: an analysis of a commercial claims database

Article

Author: Wang, Yitong ; Mychaskiw, Marko A. ; Lim, Sangtaeck ; Rubio, Jose M. ; Kane, John M. ; Suett, Mark ; Chen, Anna ; Tian, Marc

This study was designed to assess healthcare resource utilization (HCRU) and costs in patients with newly diagnosed schizophrenia based on timing and context of long-acting injectable antipsychotic agent (LAI) initiation. Using claims data, patients (aged 18–40 years) with first schizophrenia diagnosis January 2013–September 2019 (index date), no LAI or oral antipsychotic agent claims during 12-month preindex period, and continuous benefit enrollment from 12 months before index date to 12 months after first LAI administration were identified. Patients were grouped based on timing [early (≤1 year after index date) vs. late] and circumstances [reactive (after schizophrenia-related event) vs. proactive] of LAI initiation. Of 1290 patients with at least one LAI claim, 306 met criteria for early (n = 204; reactive, n = 107; proactive, n = 97) and late (n = 102; n = 75; n = 27) initiation. HCRU and costs were numerically lower in early versus late groups, and significantly lower for proactive initiation in both groups. Comparing worst-case (late-reactive) and best-case (early-proactive) scenarios, the average annual cost difference was $7195.13 (P = 0.0233), with major drivers being emergency department ($171.28; P < 0.05) and other outpatient ($2845.73; P < 0.00001) visits. In addition to the clinical advantages previously described in the literature, the proactive use of LAIs in early-phase schizophrenia is associated with lower healthcare costs.

100 Deals associated with Teva UK Ltd.

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100 Translational Medicine associated with Teva UK Ltd.

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Pipeline

Pipeline Snapshot as of 23 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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