- |||||||||| Doria (risperidone extended release) / ROVI Pharmaceuticals Laboratories, Aristada once-monthly (aripiprazole lauroxil once-monthly formulation) / Alkermes
Review, Journal: Switching to Long-Acting Injectable Antipsychotics: Pharmacological considerations and practical approaches. (Pubmed Central) - Jun 22, 2023
Future LAI developments should focus on longer dosing intervals, subcutaneous administration, expansion of LAIs beyond currently available antipsychotic agents and indications beyond schizophrenia and bipolar disorder. In the future, LAIs might become a first-line treatment after initial oral stabilization for chronic mental disorders with need for maintenance treatment and presence of significant non-adherence.
- |||||||||| Doria (risperidone extended release) / ROVI Pharmaceuticals Laboratories
Enrollment open: RESHAPE: Non-interventional Study of Risperidone ISM (clinicaltrials.gov) - Nov 10, 2022
P=N/A, N=1200, Recruiting,
It thus represents a valuable and novel therapeutic option in management of schizophrenia. Not yet recruiting --> Recruiting
- |||||||||| Doria (risperidone extended release) / ROVI Pharmaceuticals Laboratories
Efficacy of Risperidone ISM in patients with an acute exacerbation of schizophrenia: a post-hoc analysis on the PANSS-6 score (Poster area [IN-PERSON]) - Oct 13, 2022 - Abstract #ECNP2022ECNP_928;
P3
Mean change in PANSS-6 and PANSS-30 scores from baseline to Day 85 in the phase III study “PRISMA-3” PLACEBO N = 132 RISPERIDONE ISM 75 mg N = 129 RISPERIDONE ISM 100 mg N = 129 PANSS-6 Mean (SD) score baseline22.8 (2.60)22.7 (3.09)22.6 (2.83) LS Mean change from baseline to Day 85 (95% CI)*-2.9 (-3.7 to -2.1)-5.8 (-6.6 to -5.0)-5.9 (-6.8 to -5.1) Difference versus placebo (95% CI)--2.9 (-4.1 to -1.7)-3.0 (-4.2 to -1.9) P-value-<0.001<0.001 PANSS-30 [1] Mean (SD) score baseline96.4 (7.21)96.3 (8.47)96.1 (8.42) LS Mean change from baseline to Day 85 (95% CI)*-11.0 (-14.1 to -8.0)-24.6 (-27.5 to -21.6)-24.7 (-27.7 to -21.6) Difference versus placebo (95% CI)--13.0 (-17.3 to -8.8)-13.3 (-17.6 to -8.9) P-value-<0.0001<0.0001 * Analysis by a mixed model repeated measures approach. Conclusion : PANSS-6 Result s were consistent with the previously published Result s of the PRISMA-3 study based on the PANSS-30 score, showing that Risperidone ISM provides rapid and progressive reduction of symptoms in patients with acutely exacerbated schizophrenia. The brief PANSS-6 rating scale is a useful and simple tool for assessing the efficacy of antipsychotics, including Risperidone ISM.
- |||||||||| Doria (risperidone extended release) / ROVI Pharmaceuticals Laboratories
Extrapyramidal safety and tolerability profile of the new long-acting antipsychotic Risperidone ISM for the treatment of patients with schizophrenia (Poster area [IN-PERSON]) - Oct 13, 2022 - Abstract #ECNP2022ECNP_869;
P3
Mean change from baseline to end-of-treatment in the EPS-related scores over the 12-week DB and 1-year OLE phases PLACEBO RISPERIDONE-ISM 75 mg RISPERIDONE-ISM 100 mg ALL RISPERIDONE ISM DB PHASE N = 147 N = 144 N = 146 N = 290 AIMS, Mean (SD) 0.1 (1.36)-0.1 (1.98)-0.1 (1.22)-0.1 (1.64) BARS, Mean (SD) 0.1 (0.98)0.0 (0.59)0.1 (0.87)0.1 (0.75) SAS, Mean (SD) 0.1 (2.51)0.1 (0.75)0.0 (1.17)0.1 (0.98) OLE PHASE NA N = 116 N = 99 N = 215 AIMS, Mean (SD) NA0.3 (1.73)0.2 (1.07)0.3 (1.47) BARS, Mean (SD) NA0.1 (0.38)0.2 (0.64)0.1 (0.52) SAS, Mean (SD) NA0.3 (1.06)0.3 (0.76)0.3 (0.93) Conclusion : A low incidence of EPS-related TEAEs was observed during the acute and maintenance treatment with long-acting Risp-ISM in patients with schizophrenia. Furthermore, a low percentage of patients used anticholinergic or beta-blocking agents during both the DB and OLE PRISMA-3 study phases, confirming the good EPS tolerability profile of Risp-ISM, despite rapid achievement of therapeutic blood levels.
- |||||||||| Doria (risperidone extended release) / ROVI Pharmaceuticals Laboratories
Cardiovascular safety profile of the long-acting antipsychotic Risperidone ISM in patients with schizophrenia treated in a phase 3 clinical trial (Poster area [IN-PERSON]) - Oct 13, 2022 - Abstract #ECNP2022ECNP_671;
P3
Patients with treatment-related cardiovascular adverse events and change from baseline (CFB) at endpoint on QT parameters reported over the 12-week Double-Blind (DB) and 1-year Open-Label Extension (OLE) phases of PRISMA-3 Study PLACEBO RISPERIDONE ISM 75 mg RISPERIDONE ISM 100 mg ALL RISPERIDONE ISM DB PHASE N=147N=144N=146N=290 Sinus bradycardia, N (%)001 (0.7)1 (0.3) Tachycardia01 (0.7)3 (2.1)4 (0.9) QT Interval CFB, Single Beat (msec), Mean (SD)5.7 (26.08)6.9 (28.98)5.1 (25.83)6.0 (27.44) QTcB Interval CFB, Single Beat (msec), Mean (SD)3.3 (21.71)6.2 (19.97)1.0 (17.34)3.6 (18.87) QTcF Interval CFB, Single Beat (msec), Mean (SD)4.1 (16.91)6.5 (14.68)2.3 (14.07)4.4 (14.51) OLE PHASE NAN = 116N = 99N = 215 Sinus thachycardia, N (%)NA1 (0.9)01 (0.5) Tachycardia, N (%)NA02 (2.0)2 (0.9) QT Interval CFB, Single Beat (msec), Mean (SD)NA-1.1 (27.94)1.8 (22.99)0.2 (25.79) QTcB Interval CFB, Single Beat (msec), Mean (SD)NA-0.1 (17.07)0.6 (18.21)0.2 (17.55) QTcF Interval CFB, Single Beat (msec), Mean (SD)NA-0.5 (14.13)0.9 (13.44)0.1 (13.80) Conclusion : Neither new nor unexpected cardiovascular findings were observed. The changes from baseline in the QT interval were small and non-clinically significant, and the incidence of cardiovascular-related adverse events was very low in both the DB and OLE phases of the PRISMA-3 study, confirming the favorable cardiovascular profile of Risperidone ISM.
- |||||||||| Doria (risperidone extended release) / ROVI Pharmaceuticals Laboratories
Review, Journal: Risperidone ISM as a New Option in the Clinical Management of Schizophrenia: A Narrative Review. (Pubmed Central) - Oct 5, 2022
There is clinical evidence that these results are maintained in the long term. In conclusion, four-weekly risperidone ISM (75 mg and 100 mg) is an adequate antipsychotic for treating schizophrenia, both in the short term when an exacerbation has recently occurred and for long-term maintenance, since it provides rapid onset of action and sustained efficacy, as well as being safe and well tolerated.
- |||||||||| Doria (risperidone extended release) / ROVI Pharmaceuticals Laboratories
Clinical, Journal: Long-term efficacy and safety of once-monthly Risperidone ISM® in the treatment of schizophrenia: Results from a 12-month open-label extension study. (Pubmed Central) - Mar 26, 2022
In conclusion, four-weekly risperidone ISM (75 mg and 100 mg) is an adequate antipsychotic for treating schizophrenia, both in the short term when an exacerbation has recently occurred and for long-term maintenance, since it provides rapid onset of action and sustained efficacy, as well as being safe and well tolerated. Risperidone ISM® is an effective, safe, and well-tolerated long-term treatment of schizophrenia in adults, regardless of the initial disease severity or whether patients were previously treated with Risperidone ISM® during an acute exacerbation or switched from stable doses of oral risperidone.
- |||||||||| Doria (risperidone extended release) / ROVI Pharmaceuticals Laboratories
Clinical, Journal: The Steady-State Comparative Bioavailability of Intramuscular Risperidone ISM and Oral Risperidone: An Open-Label, One-Sequence Study. (Pubmed Central) - Feb 23, 2022
The rapid release of risperidone ISM allows the achievement of the desired levels similar to those observed at the steady-state after oral risperidone treatment. Therefore, direct switch after 24 hours from the last oral risperidone dose to risperidone ISM treatment can be done in schizophrenia patients with no time lag, maintaining steady-state levels of the active moiety throughout treatment and without the need for oral risperidone supplementation or loading doses.
- |||||||||| Doria (risperidone extended release) / ROVI Pharmaceuticals Laboratories, risperidone controlled-release implant (BB-0817) / Braeburn, Perseris (risperidone sustained-release 1-month depot) / Indivior, Reckitt Benckiser, HLS Therap
Review, Journal: Newer Formulations of Risperidone: Role in the Management of Psychotic Disorders. (Pubmed Central) - Aug 20, 2021
All three preparations have been shown to be effective and well tolerated in clinical trials. A fourth formulation (TV-46000), which can be given subcutaneously every 1 or 2 months, has recently begun trials.
- |||||||||| Doria (risperidone extended release) / Rovi Pharmaceuticals Laboratories, Perseris (risperidone sustained-release 1-month depot) / Indivior, Reckitt Benckiser, HLS Therap, Risperdal Consta (risperidone depot formulation) / J&J
[VIRTUAL] A Comparison of the Pharmacokinetics, Efficacy, and Tolerability of Long-Acting Injectable Risperidone Formulations () - Apr 4, 2021 - Abstract #CPNP2021CPNP_18;
Consta® could be considered first-line because it is well-tolerated, offers more potential for an individualized dosing regimen, and has the greatest PANSS score reduction. As new formulations gain FDA-approval, it is essential that prescribers engage in multifactorial decision-making centered around each individual's needs.
- |||||||||| Doria (risperidone extended release) / Rovi Pharmaceuticals Laboratories
Journal: Newer Formulations of Risperidone: Remarks About Risperidone ISM. (Pubmed Central) - Feb 27, 2021
As new formulations gain FDA-approval, it is essential that prescribers engage in multifactorial decision-making centered around each individual's needs. No abstract available
- |||||||||| Doria (risperidone extended release) / Rovi Pharmaceuticals Laboratories
Journal: Redescription of the type specimens of Althepus pictus Thorell, 1898 (Araneae, Psilodercidae) from Myanmar. (Pubmed Central) - Oct 21, 2020
The species is redescribed here based on the original male and female type specimens deposited in Museo Civico di Storia Naturale 'Giacomo Doria' (MSNG) in Italy...No information is available on the female specimen from Farm Caves, which maybe have been lost. No fresh material of this species has been collected in region during five subsequent expeditions to Myanmar tours organized by the Southeast Asia Biodiversity Research Institute in the years 2016-2020.
- |||||||||| Doria (risperidone extended release) / Rovi Pharmaceuticals Laboratories
Journal: Exploring design variations of the Titian Stradivari violin using a finite element model. (Pubmed Central) - Oct 4, 2020
This agrees with the widespread belief that the high-frequency response of Stradivari violins is stronger than Guarneri violins. Changes in the response of the system were quantified once each part of the design was added, calling attention to the influence of the blocks on the behavior of signature modes, especially in the frequency and shape of B. A text file of the FE model is available in supplemental materials; it runs in ANSYS (free version), for which guides are included.
- |||||||||| Doria (risperidone extended release) / ROVI Pharmaceuticals Laboratories
Trial completion: PRISMA-3_OLE: Study to Evaluate the Efficacy and Safety of Risperidone ISM® in Patients With Acute Schizophrenia: Open Label Extension (clinicaltrials.gov) - Feb 5, 2020
P3, N=215, Completed,
Thus, additional mechanisms of action and agents require study to improve schizophrenia outcomes for total/positive symptoms with reduced adverse effects, but also cognitive symptoms, negative symptoms, and treatment resistance, the areas of greatest need in schizophrenia currently. Active, not recruiting --> Completed
- |||||||||| Doria (risperidone extended release) / ROVI Pharmaceuticals Laboratories
Trial completion: Comparative Bioavailability of Risperidone (clinicaltrials.gov) - Jul 1, 2019
P1, N=81, Completed,
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||||||||| Doria (risperidone extended release) / ROVI Pharmaceuticals Laboratories
Trial primary completion date: Comparative Bioavailability of Risperidone (clinicaltrials.gov) - Jan 18, 2019
P1, N=81, Active, not recruiting,
Active, not recruiting --> Completed | Trial completion date: Jan 2020 --> Dec 2018 Trial primary completion date: Sep 2018 --> Mar 2019
- |||||||||| Doria (risperidone extended release) / ROVI Pharmaceuticals Laboratories
Enrollment closed: Comparative Bioavailability of Risperidone (clinicaltrials.gov) - Sep 12, 2018
P1, N=65, Active, not recruiting,
Recruiting --> Active, not recruiting | Trial completion date: Jan 2019 --> Jan 2020 Recruiting --> Active, not recruiting
- |||||||||| Doria (risperidone extended release) / ROVI Pharmaceuticals Laboratories
Enrollment open: Comparative Bioavailability of Risperidone (clinicaltrials.gov) - Jul 20, 2018
P1, N=58, Recruiting,
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
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