- |||||||||| ulotaront (SEP-363856) / Sumitomo Pharma, Otsuka, PsychoGenics
Review of the Taar1 Agonist Ulotaront: Part II - Summary of Initial Clinical Efficacy/Safety Results (Hall B Foyer, Exhibition Level Moscone South) - May 17, 2023 - Abstract #APA2023APA_1470;
In the double-blind study, ulotaront was associated with significant (p<0.001) endpoint improvement in the PANSS total score (effect size [ES]: 0.45), the CGI-Severity score (ES: 0.52) and the Brief Negative Symptom Scale total score (ES: 0.48) [1]. In a post-hoc enrichment analysis, ulotaront demonstrated moderate-to-large treatment effects on negative symptoms with an endpoint MPNS factor score effect size of 0.84 (vs. 0.33 on the atypical antipsychotic lurasidone).
- |||||||||| lurasidone / Generic mfg.
Two Birds, One Stone: Lurasidone Pharmacotherapy for Comorbid Autism Spectrum Disorder and Schizophrenia (Hall B Foyer, Exhibition Level Moscone South) - May 17, 2023 - Abstract #APA2023APA_555;
Since Lurasidone is prescribed to treat symptoms of both disorders, it was chosen for use in the above patient, especially after he could not tolerate Aripiprazole and Risperidone. This case report describes using Lurasidone as a pharmacotherapy for symptoms of psychosis, which also decreased the patient's agitation and irritability symptoms.
- |||||||||| lurasidone / Generic mfg., ibuprofen / Generic mfg.
Journal: Are all poorly soluble drugs dissolved in deep eutectic solvents true solutions? (Pubmed Central) - May 13, 2023
In addition, the colloidal system with polydispersity shows superior physical and chemical stability. Different to the prevailing view that substances are fully dissolved in DES, this study discovers another existence state as stable colloidal particles in DES.
- |||||||||| Lodopin (zotepine) / Astellas
Retrospective data, Review, Journal: Long-term efficacy of antipsychotic drugs in initially acutely ill adults with schizophrenia: systematic review and network meta-analysis. (Pubmed Central) - May 9, 2023
In terms of overall symptoms, olanzapine was on average more efficacious than ziprasidone (standardized mean difference, SMD=0.37, 95% CI: 0.26-0.49), asenapine (SMD=0.33, 95% CI: 0.21-0.45), iloperidone (SMD=0.32, 95% CI: 0.15-0.49), paliperidone (SMD=0.28, 95% CI: 0.11-0.44), haloperidol (SMD=0.27, 95% CI: 0.14-0.39), quetiapine (SMD=0.25, 95% CI: 0.12-0.38), aripiprazole (SMD=0.16, 95% CI: 0.04-0.28) and risperidone (SMD=0.12, 95% CI: 0.03-0.21)...The differences between olanzapine and lurasidone, amisulpride, perphenazine, clozapine and zotepine were either small or uncertain...Concerning weight gain, the impact of olanzapine was higher than all other antipsychotics, with a mean difference ranging from -4.58 kg (95% CI: -5.33 to -3.83) compared to ziprasidone to -2.30 kg (95% CI: -3.35 to -1.25) compared to amisulpride. Our data suggest that olanzapine is more efficacious than a number of other antipsychotic drugs in the longer term, but its efficacy must be weighed against its side effect profile.
- |||||||||| Rexulti (brexpiprazole) / Lundbeck, Otsuka
Review, Journal: Narrative review of the advances in the pharmacotherapeutic management of juvenile-onset schizophrenia. (Pubmed Central) - Apr 27, 2023
Since 2012, lurasidone (2017) and brexpiprazole (2022) have also been approved...Antipsychotics can induce adaptive changes in the brain that predispose patients to future problems such as tardive dyskinesia and supersensitivity psychosis. When pathophysiology of schizophrenia, and a clear understanding of the pharmacology of existing antipsychotics are included in the evidence-based analysis, use of partial agonists, that are less likely to induce adaptive changes in the brain, and less likely to induce metabolic and prolactin side effects, become the preferred agents.
- |||||||||| aripiprazole / Generic mfg., lurasidone / Generic mfg.
Clinical guideline, Review: Polish Psychiatric Association diagnostic and therapeutic management guidelines for patients with early-onset schizophrenia. (Pubmed Central) - Apr 23, 2023
Second-generation antipsychotic agents approved for the treatment of early-onset schizophrenia - aripiprazole, lurasidone and paliperidone - enable its effective and safe treatment. The necessary complement to pharmacological therapy is non-pharmacological interventions that should be adapted to the patient's age, cognitive abilities, disease stage and the needs of the whole family.
- |||||||||| lithium carbonate ER / Generic mfg.
Journal: An update on potential pharmacotherapies for cognitive impairment in bipolar disorder. (Pubmed Central) - Apr 17, 2023
Traditional treatments, such as lithium, anticonvulsants (lamotrigine), antipsychotics (aripiprazole, asenapine, cariprazine, lurasidone, and olanzapine), antidepressants (vortioxetine, fluoxetine, and tianeptine) and psychostimulants (modafinil), and emerging interventions, such as acetylcholinesterase inhibitors (galantamine and donepezil), dopamine agonists (pramipexole), erythropoietin, glucocorticoid receptor antagonists (mifepristone), immune modulators (infliximab, minocycline and doxycycline), ketamine, metabolic agents (insulin, metformin, and liraglutide), probiotic supplements, and Withania somnifera are discussed...In the past, methodological pitfalls in BD cognition trials have also been a critical limiting factor. Expanding on the existing literature and identifying novel pharmacological and non-pharmacological treatments for cognitive impairment in BD should be a priority.
- |||||||||| ulotaront (SEP-363856) / Sumitomo Pharma, Otsuka, PsychoGenics
Review of the TAAR1 Agonist Ulotaront: Part II - Summary of Initial Clinical Efficacy/Safety Results (Salon 4) - Apr 15, 2023 - Abstract #ASCP2023ASCP_199;
In the double-blind study, ulotaront was associated with significant (p<0.001) endpoint improvement in the PANSS total score (effect size [ES]: 0.45), the CGI-Severity score (ES: 0.52) and the Brief Negative Symptom Scale total score (ES: 0.48). In a post-hoc enrichment analysis, ulotaront demonstrated moderate-to-large treatment effects on negative symptoms with an endpoint MPNS factor score effect size of 0.84 (vs. 0.33 on the atypical antipsychotic lurasidone).
- |||||||||| lurasidone / Generic mfg.
Enrollment status, Trial completion date, Trial primary completion date: The Safety and Effectiveness of Latuda (clinicaltrials.gov) - Apr 13, 2023
P=N/A, N=3000, Enrolling by invitation,
Not yet recruiting --> Enrolling by invitation Recruiting --> Enrolling by invitation | Trial completion date: Jan 2023 --> Jun 2024 | Trial primary completion date: Oct 2022 --> Mar 2023
- |||||||||| Cyclurad (cycloserine/lurasidone) / NRx Pharma, Alvogen
Trial completion date, Trial primary completion date: MBD: NRX-101 for Bipolar Depression With Subacute Suicidal Ideation (clinicaltrials.gov) - Mar 29, 2023
P2, N=70, Recruiting,
Not yet recruiting --> Active, not recruiting Trial completion date: May 2023 --> Nov 2023 | Trial primary completion date: Mar 2023 --> Sep 2023
- |||||||||| clozapine / Generic mfg.
Leveraging SMI Adviser (Poinciana 1-2) - Mar 18, 2023 - Abstract #ASCP2023ASCP_78;
2. Describe the process by which up-to-date, peer-reviewed information can be disseminated through SMI Adviser.
- |||||||||| lurasidone / Generic mfg.
Preclinical, Journal: Early effects of lurasidone treatment in a chronic mild stress model in male rats. (Pubmed Central) - Mar 14, 2023
Trial completion date: Feb 2023 --> Apr 2024 | Trial primary completion date: Feb 2023 --> Jan 2024 These results suggest that the capacity of lurasidone to normalize anhedonia at an early stage of treatment may depend on its ability to modulate the function of the prefrontal cortex.
- |||||||||| lurasidone / Generic mfg., quetiapine / Generic mfg.
Clinical guideline, Review, Journal: Antipsychotic drugs for women: a narrative review and clinical guidelines (Pubmed Central) - Mar 14, 2023
In fact, some patients who did not show early response at 2?weeks might have marked improvement at 6?weeks. Clinicians should be aware that women should be treated differently with antipsychotics than men.
- |||||||||| ulotaront (SEP-363856) / Sumitomo Pharma, Otsuka, PsychoGenics
Review of the TAAR1 Agonist ulotaront: Part Ii - Summary of InitialClinical efficacy/safety Results () - Mar 10, 2023 - Abstract #SIRS2023SIR_411;
Also summarized are post-hoc analyses comparing the effectof ulotaront vs. lurasidone on negative symptoms (based on a Marder PANSS negative symptomfactor [MPNS] enrichment strategy); and analyses comparing key safety and adverse event (AE)domains for ulotaront vs. atypical antipsychotics (APs), including an Empirical Bayes GeometricMean (EBGM) analysis of the FDA Adverse Event Reporting System (FAERS) database.Results In the double-blind study, short-term treatment with ulotaront was associated withsignificant (p<0.001) endpoint improvement in the PANSS total score (effect size [ES]: 0.45), theCGI-Severity score (ES: 0.52) and the Brief Negative Symptom Scale (BNSS) total score (ES: 0.48)[1]...The follow-up study [2] further confirmed the tolerability ofulotaront, with a 6-month completion rate of 67%, which compares favourably to benchmark6-month completion rates in the CATIE study [3] (e.g., olanzapine, 55%; risperidone, 43%;quetiapine, 29%)...Thesafety and tolerability profile of ulotaront is markedly different with respect to class-related AEsthat are characteristic of both first- and second-generation antipsychotics. The benefit-risk profile ofulotaront, as a member of a novel TAAR1 agonist class, is distinguished from antipsychotics by lackof D2 and 5-HT2A receptor blockade.KeywordKeywordsUlotarontTAAR1 agonistAntipsychotic agentsAcute schizophreniarandomized clinical trialPoster Award NoPlease list all co-authors for this poster submission.* Presenting AuthorFirst Name Last Name AffiliationSeth C. Hopkins Sunovion Pharmaceuticals, Inc.Heather Dworak Sunovion Pharmaceuticals Inc.Courtney * Zeni * Sunovion PharmaceuticalsKenneth S. Koblan Sunovion Pharmaceuticals, Inc.Consent of Release of Rights I have read and agree to the above terms and conditions.
- |||||||||| Cyclurad (cycloserine/lurasidone) / NRx Pharma, Alvogen
Trial primary completion date: MBD: NRX-101 for Bipolar Depression With Subacute Suicidal Ideation (clinicaltrials.gov) - Mar 8, 2023
P2, N=70, Recruiting,
The benefit-risk profile ofulotaront, as a member of a novel TAAR1 agonist class, is distinguished from antipsychotics by lackof D2 and 5-HT2A receptor blockade.KeywordKeywordsUlotarontTAAR1 agonistAntipsychotic agentsAcute schizophreniarandomized clinical trialPoster Award NoPlease list all co-authors for this poster submission.* Presenting AuthorFirst Name Last Name AffiliationSeth C. Hopkins Sunovion Pharmaceuticals, Inc.Heather Dworak Sunovion Pharmaceuticals Inc.Courtney * Zeni * Sunovion PharmaceuticalsKenneth S. Koblan Sunovion Pharmaceuticals, Inc.Consent of Release of Rights I have read and agree to the above terms and conditions. Trial primary completion date: Dec 2022 --> Mar 2023
- |||||||||| lurasidone / Generic mfg., clozapine / Generic mfg.
Journal: Lurasidone Augmentation of Clozapine in Refractory Schizophrenia: A Case Series. (Pubmed Central) - Mar 4, 2023
Trial primary completion date: Dec 2022 --> Mar 2023 Our observation suggests that lurasidone can lead to clinically significant improvements in psychopathology with a good tolerability profile when added to clozapine.
- |||||||||| lurasidone / Generic mfg.
Journal: Mechanistic insights into the crystallization of coamorphous drug systems. (Pubmed Central) - Mar 2, 2023
In our previous study, the coamorphous formulation of lurasidone hydrochloride (LH) with saccharin (SAC) showed significantly enhanced dissolution and physical stability compared to crystalline/amorphous LH...In addition, molecular dynamics simulations with miscibility, radial distribution function and binding energy calculations suggested coamorphous components exhibited good miscibility and strong intermolecular interactions, which also was conductive to the enhancement in its stability. This study offers an in-depth understanding about the effect of the coformer on the crystallization kinetics of coamorphous systems, and points out the important contribution of the configurational entropy in stabilizing the coamorphous systems.
- |||||||||| lithium carbonate ER / Generic mfg.
Combination therapy for bipolar disorder (08. Room Passy) - Mar 2, 2023 - Abstract #EPA2023EPA_242;
Adjunctive treatment of olanzapine with fluoxetine may be necessary in a depression with mixed features... Rational polytherapy allows better and faster control over symptoms of bipolar disorder and should be considered after a detailed discussion of risks and benefits.
- |||||||||| Trintellix (vortioxetine) / Lundbeck, Takeda
Review, Journal: Therapeutic Potential and Limitation of Serotonin Type 7 Receptor Modulation. (Pubmed Central) - Feb 12, 2023
The other is that activation of 5-HT7 can improve transmission dysfunction due to microstructure abnormality in the neurotransmission network-which could be unaffected by conventional therapeutic agents-via modulating intracellular signalling during the neurodevelopmental stage or via loss of neural networks with aging. This review attempts to describe the current and novel clinical applications of 5-HT7 modulation based on preclinical findings.
- |||||||||| lurasidone / Generic mfg.
Journal: Improving Lurasidone Hydrochloride's Solubility and Stability by Higher-Order Complex Formation with Hydroxypropyl-β-cyclodextrin. (Pubmed Central) - Jan 22, 2023
Phase solubility,H-NMR, and docking computational characterization suggested that the main stoichiometric ratio was 1:1; however, we cannot rule out a 1:2 ratio, where a second cyclodextrin molecule could bind through the isoindole-1,3-dione ring, improving its stability as well. Finally, we can conclude that the formation of higher-order inclusion complexes of lurasidone with hydroxypropyl-β-cyclodextrin is a successful strategy to increase the solubility and stability of the drug.
- |||||||||| lurasidone / Generic mfg.
Journal: Microbial degradation products of lurasidone and their significance in postmortem toxicology. (Pubmed Central) - Jan 18, 2023
This finding is significant for toxicology laboratories screening for this drug in postmortem casework. The major postmortem lurasidone degradation product has consequently been added to the LC-QTOF-MS drug screen at Forensic Science SA (FSSA) to indicate postmortem lurasidone degradation in authentic postmortem blood specimens and as a marker of lurasidone administration in the event lurasidone is degraded to concentrations below detection limits.
- |||||||||| lurasidone / Generic mfg.
Trial termination: A Study of Lurasidone Compared With Placebo for the Treatment of Bipolar I Depression (clinicaltrials.gov) - Jan 17, 2023
P3, N=124, Terminated,
The major postmortem lurasidone degradation product has consequently been added to the LC-QTOF-MS drug screen at Forensic Science SA (FSSA) to indicate postmortem lurasidone degradation in authentic postmortem blood specimens and as a marker of lurasidone administration in the event lurasidone is degraded to concentrations below detection limits. Active, not recruiting --> Terminated; Company's business decision
- |||||||||| Rexulti (brexpiprazole) / Lundbeck, Otsuka, Serlect (sertindole) / Lundbeck, Abbott
Journal, Adverse events: Antipsychotics and risk of QT prolongation: a pharmacovigilance study. (Pubmed Central) - Dec 16, 2022
Our results suggest that lurasidone is less associated with QT interval prolongation reports. Our study also suggests that antipsychotics with the higher hERG affinity are more associated with to QT prolongations reports.
- |||||||||| lithium carbonate ER / Generic mfg.
Journal: Psychopharmacological Treatment Algorithms of Manic/Mixed and Depressed Episodes in Pediatric Bipolar Disorder. (Pubmed Central) - Dec 7, 2022
We offer an update to the 2005 AACAP algorithms for the treatment of pediatric bipolar mixed/manic episodes and added an evidence-based algorithm for the treatment of depression in PBD. In addition to treatment algorithms, we review current evidence for efficacy of agents proposed in the AACAP algorithm and provide tables summarizing medication side effects and efficacy.
- |||||||||| lurasidone / Generic mfg.
Journal: Effectiveness of Lurasidone 80 mg in Patients with Schizophrenia: Results of an Open-Label, 12-Week Extension Study. (Pubmed Central) - Nov 18, 2022
Discontinuation rates due to adverse events on lurasidone modal 80 mg/d vs 40 mg/d were 4.4% vs 7.2%; and the most common adverse events in the modal 80 mg/d group were nasopharyngitis, 7.4% (vs 4.6% on modal 40 mg/d), constipation, 5.9% (vs 2.0%), and headache, 5.9% (vs 2.0%). In patients with acute schizophrenia treated with lurasidone 40 mg/d, increasing the dose to 80 mg/d was well tolerated, and was associated with greater improvement in PANSS subscale scores compared to continued treatment with a dose of 40 mg/d.
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