Phase II trial evaluating the safety and efficacy of a 5-day administration of ME2136 combined with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based highly emetogenic chemotherapy

Start Date16 Jul 2024

Sponsor / Collaborator-

CTR20240253 / Active, not recruitingNot Applicable

一项评价阿塞那平透皮贴剂在健康成年人中药代动力学特征及安全性的临床研究

[Translation] A clinical study to evaluate the pharmacokinetic characteristics and safety of asenapine transdermal patch in healthy adults

主要研究目的:评价阿塞那平透皮贴剂 (ASE TTS) 单次给药与阿塞那平透皮贴剂(Secuado®)多次给药的药代动力学特征; 次要研究目的:评价使用阿塞那平透皮贴剂后受试者的安全性；评估阿塞那平透皮贴剂 (ASE TTS) 的黏附性；评估阿塞那平透皮贴剂 (ASE TTS) 的药物残留量。

[Translation]

Primary study objectives: To evaluate the pharmacokinetic characteristics of single-dose and multiple-dose asenapine transdermal patches (ASE TTS); Secondary study objectives: To evaluate the safety of subjects after using asenapine transdermal patches; To evaluate the adhesion of asenapine transdermal patches (ASE TTS); To evaluate the drug residue in asenapine transdermal patches (ASE TTS).

Start Date28 Feb 2024

Sponsor / Collaborator

LTS LOHMANN Therapie-Systeme AG

[+2]

CTR20222759 / CompletedPhase 3

评价马来酸阿塞那平舌下片治疗急性期精神分裂症的有效性和安全性的随机、双盲、阳性对照、多中心临床试验

[Translation] A randomized, double-blind, positive-controlled, multicenter clinical trial to evaluate the efficacy and safety of asenapine maleate sublingual tablets in the treatment of acute schizophrenia

评价马来酸阿塞那平舌下片治疗急性期精神分裂症的有效性和安全性

[Translation]

To evaluate the efficacy and safety of asenapine maleate sublingual tablets in the treatment of acute schizophrenia

Start Date11 Jan 2023

Sponsor / Collaborator

Harbin Medisan Pharmaceutical Co., Ltd.

100 Clinical Results associated with Asenapine Maleate

100 Translational Medicine associated with Asenapine Maleate

100 Patents (Medical) associated with Asenapine Maleate

475

Literatures (Medical) associated with Asenapine Maleate

01 Dec 2024·INVESTIGATIONAL NEW DRUGS

A phase II study of ME2136 (Asenapine Maleate) plus standard antiemetic therapy for patients, including diabetic patients, receiving cisplatin-based chemotherapy

Article

Author: Murakami, Haruyasu ; Hamauchi, Satoshi ; Yasui, Hirofumi ; Ono, Akira ; Kado, Nobuhiro ; Mori, Keita ; Takahashi, Toshiaki ; Yamazaki, Kentaro ; Yokota, Tomoya ; Tsushima, Takahiro ; Onozawa, Yusuke ; Hirashima, Yasuyuki ; Fushiki, Kunihiro ; Naito, Tateaki

Olanzapine combined with the neurokinin-1 receptor antagonist, palonosetron and dexamethasone is the standard treatment for chemotherapy-induced nausea and vomiting (CINV) due to highly emetogenic chemotherapy (HEC). However, the use of olanzapine poses challenges in patients with diabetes mellitus (DM) due to the potential risk of hyperglycemia. ME2136, antipsychotic similar to olanzapine, is associated with a lower risk of hyperglycemia. This study investigated the antiemetic efficacy and safety of ME2136 for HEC. This single-arm phase 2 study examined the safety and efficacy of ME2136 5 mg for 4 days in combination with triplet-combination antiemetic therapy. Two cohorts were established for the safety assessment: DM and non-DM. Eligible patients had malignant tumors and were receiving cisplatin-based chemotherapy for the first time. The primary endpoint was the complete response (CR) rate, defined as the percentage of patients without vomiting and not requiring rescue medications in the delayed phase (24-120 h). Between December 2020 and January 2022, 40 patients were enrolled, with 20 in each cohort. All patients were included in the safety analysis and 35 in the efficacy analysis. The CR rate in the delayed phase was 71.4% [60% CI 63.1-78.6%] for all patients, 66.7% in the DM cohort, and 76.5% in the non-DM cohort. No treatment-related adverse events ≥ grade 3, including hyperglycemia, were reported. ME2136, when combined with standard triplet-combination antiemetic therapy, is expected to exert similar antiemetic effects to the standard treatment for CINV due to HEC. Currently, ME2136-02 trial is underway to examine the safety and efficacy of triplet-combination antiemetic therapy and a 5-day treatment with ME2136. This study was registered with the Japan Registry of Clinical Trials (jRCT2041200071) on 10 December 2020. Clinical trial registration: This study was registered with the Japan Registry of Clinical Trials (jRCT2041200071) on 10 December 2020.

02 Aug 2024·Expert Review of Neurotherapeutics

An overview of the efficacy and safety of brexpiprazole for the treatment of schizophrenia in adolescents

Review

Author: Abuelazm, Hagar ; Crump, Chesika J. ; El-Mallakh, Rif S. ; Ibrahim, Kirolos ; Shah, Shaishav

INTRODUCTION:

The onset of psychotic symptoms occurs prior to age 19 in 39% of the patients with schizophrenia. There are limited approved treatment options for adolescents with schizophrenia. Brexpiprazole was approved by the United States Food and Drug Administration (FDA) for treatment of schizophrenia in adolescents in 2022.

AREAS COVERED:

Extrapolation of adult data to youth and use of pharmacologic modeling coupled with open long-term safety data were used by the FDA to approve brexpiprazole for adolescent schizophrenia. They were all reviewed herein.

EXPERT OPINION:

D2 receptor partial agonist antipsychotic agents are preferred in the early phase of treatment of psychotic disorders. Approval of brexpiprazole in adolescent schizophrenia provides an additional option. Brexpiprazole was approved by the FDA on the basis of extrapolation of adult data without controlled trials in adolescents. This reduces placebo exposure in young people. Two previous agents (asenapine and ziprasidone) approved for adult schizophrenia failed to separate from placebo in adolescent schizophrenia studies; this partially undermines the process of extrapolation. For brexpiprazole, the paucity of data in adolescents relegates it to a second-line agent. More research on brexpiprazole is needed to delineate its relative role in the management of adolescent schizophrenia.

01 Aug 2024·JOURNAL OF THE AMERICAN ACADEMY OF CHILD AND ADOLESCENT PSYCHIATRY

Systematic Review and Network Meta-Analysis: Efficacy and Safety of Antipsychotics vs Antiepileptics or Lithium for Acute Mania in Children and Adolescents

Article

Author: Correll, Christoph U ; Blom, Thomas J ; Nöhles, Viktor B ; Kowatch, Robert A ; Vita, Giovanni ; Ostuzzi, Giovanni ; DelBello, Melissa P ; Heuer, Fabiola H ; Welge, Jeffrey A ; Keller, Amanda ; Barbui, Corrado ; Tedeschi, Federico

OBJECTIVE:

To compare second-generation antipsychotics (SGAs) and mood stabilizers (MSs) in youth with a bipolar disorder type I (BD-I) manic/mixed episode.

METHOD:

A systematic PubMed/Embase/PsycInfo literature search until December 31, 2023, for randomized trials of SGAs or MSs in patients ≤18 years of age with BD-I manic/mixed episode was conducted. The study included a network meta-analysis comparing treatments regarding mania symptoms and mania response (co-primary outcomes), and secondary efficacy and tolerability outcomes.

RESULTS:

Eighteen studies (n = 2844, mean age = 11.74, female participants = 48.0%, mean study duration = 5.4 weeks) comparing 6 SGAs (aripiprazole, asenapine, olanzapine, quetiapine, risperidone, and ziprasidone) and 4 MSs (lithium, oxcarbazepine, topiramate, and valproate) were meta-analyzed. All 6 SGAs outperformed placebo in reducing manic symptomatology, including risperidone (standardized mean difference [SMD] = -1.18, 95% CI = -0.92, -1.45, Confidence in Network Meta-Analysis [CINeMA] = moderate confidence), olanzapine (SMD = -0.77, 95% CI = -0.36, -1.18, low confidence), aripiprazole (SMD = -0.67, 95% CI = -0.33, -1.01, moderate confidence), quetiapine (SMD = -0.60, 95% CI = -0.32, -0.87, high confidence), asenapine (SMD = -0.54, 95% CI = -0.19, -0.89, moderate confidence), and ziprasidone (SMD = -0.43, 95% CI = -0.17, 0.70, low confidence), whereas no mood stabilizer outperformed placebo. Concerning mania response, risperidone (Risk ratio [RR] = 2.58, 95% CI = 1.88, 3.54, low confidence), olanzapine (RR = 2.42, 95% CI = 1.33, 3.54, very low confidence), aripiprazole (RR = 2.05, 95% CI = 1.44, 2.92, low confidence), quetiapine (RR = 1.89, 95% CI = 1.45n 2.47, moderate confidence), asenapine (RR = 1.81, 95% CI = 1.28, 2.55, very low confidence) and lithium (RR = 1.35, 95% CI = 1.00, 1.83, p = .049, very low confidence) outperformed placebo, without superiority of other MSs vs placebo. Individually, risperidone was more efficacious in reducing manic symptomatology than all other comparators, except olanzapine and topiramate, yet with low/very low confidence, and was associated with increased prolactin and glucose. Pooled together, SGAs outperformed both placebo and MSs for mania symptom reduction (SMD = -0.68, 95% CI = -0.86, -0.51 and SMD = -0.61, 95% CI = -0.82, -0.40, moderate confidence), and mania response (RR = 1.85, 95% CI = 1.53, 2.24 and RR = 1.65, 95% CI = 1.33, 2.04, moderate confidence) without differences between MSs and placebo. There were no significant treatment-placebo differences for all-cause discontinuation, whereas lithium, ziprasidone, and oxcarbazepine were associated with more adverse event-related drop-outs than placebo. Most SGAs were associated with more sedation, weight gain, and metabolic issues vs placebo and MSs.

CONCLUSION:

SGAs were more efficacious than placebo and MSs in treating acute mania symptoms, however, their use must be carefully weighed against important side effects.

News (Medical) associated with Asenapine Maleate

26 Aug 2024

·www.prnewswire.com

Schizophrenia Market: RISVAN's Approval Has Sparked a Competitive Race Among Pharmaceutical Companies | DelveInsight

The recent approval of Rovi Pharmaceuticals Laboratories' OKEDI/RISVAN (risperidone ISM) has spiked the competition among the other pharmaceutical companies that are developing novel therapies to improve the treatment landscape. RISVAN has the potential to become a blockbuster drug. LAS VEGAS, Aug. 26, 2024 /PRNewswire/ -- Schizophrenia is a severe mental illness affecting about 1% of Americans, cognitive functions, emotional responses, decision-making, and social interaction. Onset typically occurs in late teens to early 20s for men and late 20s to early 30s for women. Currently, as per the WHO, the vast majority of schizophrenia patients around the world are not receiving mental health care. Approximately 50% of people in mental hospitals have a schizophrenia diagnosis, and only 31.3% of people with psychosis receive specialist mental health care. As per DelveInsight analysis, in 2023 the total diagnosed prevalent cases of schizophrenia in the 7MM were found to be approximately 4 million cases out of which the US accounted for nearly 1.5 million cases. It is anticipated that these numbers will rise by 2034 due to several factors, including population growth, improved diagnostic techniques, increased awareness, and reduced stigma around mental health issues prompting more individuals to seek diagnosis, and potentially, environmental stressors contributing to a higher occurrence of the disorder. Schizophrenia treatment involves a blend of medication, psychological counseling, and social support. However, nearly one-third of patients do not respond sufficiently to standard treatments. Relapses, characterized by psychotic symptoms and functional impairments, are significant. Schizophrenia treatment mainly consists of antipsychotic medications that target dopamine neurotransmitters. Second-generation medications are favored because they lower the risk of severe side effects. Long-acting injectable antipsychotics can enhance adherence and improve treatment outcomes. High-dose regimens of specific medications may be advantageous for patients with severe, treatment-resistant schizophrenia. Additionally, hospitalization and electroconvulsive therapy might be necessary for patients who do not respond to medication therapy or during severe episodes. First-generation antipsychotics like chlorpromazine, fluphenazine, haloperidol, and perphenazine are effective in treating positive symptoms such as hallucinations and delusions but do not alleviate negative symptoms or cognitive impairments. Second-generation antipsychotics, including REXULTI/RXULTI (brexpiprazole), CAPLYTA (lumateperone), LATUDA (lurasidone hydrochloride), SAPHRIS (asenapine), ABILIFY MYCITE (aripiprazole tablets with sensor), VRAYLAR/REAGILA (cariprazine), SECUADO (asenapine), INVEGA SUSTENNA/TRINZA/HAYFERA (paliperidone palmitate), ARISTADA/ARISTADA INITIO (aripiprazole lauroxil), PERSERIS (risperidone), FANAPT (iloperidone), and LYBALVI (olanzapine and samidorphan), were developed to address both positive and negative symptoms, as well as cognitive symptoms. Although these medications typically have fewer extrapyramidal side effects, they can cause weight gain, sexual dysfunction, and other metabolic disorders. Additionally, elderly patients using FGAs and SGAs are at an increased risk of developing pneumonia. Learn more about the FDA-approved schizophrenia drugs @ Drugs for Schizophrenia Treatment REXULTI (brexpiprazole) is an oral tablet available in strengths from 0.25 mg to 4 mg, containing various inactive ingredients. While its exact mechanism of action is not fully understood, it work as a partial agonist at serotonin 5-HT1A and dopamine D2 receptors and as an antagonist at serotonin 5-HT2A receptors. REXULTI was first approved in the US in July 2015 for use in adults with MDD and schizophrenia. In January 2022, it received FDA approval for pediatric patients aged 13–17. The EMA approved it in July 2018, and Japan approved it in tablet form in January 2018 and as an oral-disintegrating dose in August 2021. Generic versions of REXULTI have now been approved, which may affect its market presence. Janssen Pharmaceutical's INVEGA SUSTENNA/INVEGA TRINZA/INVEGA HAFYERA (paliperidone palmitate) is an SGA agent that seems to act as a D2 partial agonist and a 5-HT-2A receptor antagonist. INVEGA SUSTENNA is administered monthly, INVEGA TRINZA every three months, and INVEGA HAFYERA twice yearly. Paliperidone is a benzisoxazole derivative. In the EU and Japan, INVEGA SUSTENNA is marketed as XEPLION. In the EU, INVEGA TRINZA is sold as TREVICTA, and in Japan as XEPLION TRI. INVEGA HAFYERA is a long-acting injectable treatment administered in the upper buttocks every six months, providing continuous treatment and symptom control over this period. Additionally, the recent approval of RISVAN (Risperidone ISM) has intensified the competition in the schizophrenia treatment space. Risperidone ISM is a long-acting injectable antipsychotic created and patented by ROVI for treating schizophrenia in adults. From the first injection, it delivers immediate and sustained plasma drug levels without the need for loading doses or additional oral risperidone. This approval is based on the positive outcomes of the pivotal PRISMA-3 study, which assessed the efficacy and safety of Risperidone ISM in patients with schizophrenia. The study's findings demonstrate that the two doses tested (75 mg and 100 mg administered once monthly) successfully met the predetermined primary and secondary efficacy endpoints for treating patients with moderate to severe schizophrenia symptoms. Furthermore, OKEDI (risperidone ISM) was launched in Germany, the UK, and Spain in 2022. The approval was based on the positive results of the pivotal PRISMA-3 study on the efficacy and safety of risperidone ISM in schizophrenia patients. As per the estimates by Delveinsight analysts, this drug has blockbuster potential in the schizophrenia market with medium-fast uptake. To know more about schizophrenia treatment options, visit @ New Treatment for Schizophrenia The schizophrenia market is crowded with so many companies working in the domain. Various potential therapies that are projected to enter during the forecast period include Boehringer Ingelheim's Iclepertin (BI-425809), Sumitomo Pharma/Otsuka's Ulotaront (SEP-363856), Reviva Pharmaceuticals' Brilaroxazine (RP5063), Minerva Neurosciences/Mitsubishi Tanabe Pharma's Roluperidone (MIN-101/MT-210), Karuna Therapeutics (Bristol Myers Squibb)/Royalty Pharma's KarXT (xanomeline-trospium), ACADIA Pharmaceuticals' NUPLAZID (pimavanserin), Teva Pharmaceutical/MedinCell/Royalty Pharma's Olanzapine LAI (mdc-TJK/TV-44749), Neurocrine Biosciences/Mitsubishi Tanabe Pharma's Valbenazine (NBI-98854), Lyndra Therapeutics' LYN-005 (long-acting oral risperidone), Newron Pharmaceuticals' Evenamide (NW-3509), Luye Pharma's LY03010 (ER paliperidone palmitate), and others. Discover which therapies are expected to grab major schizophrenia market share @ Schizophrenia Market Report Iclepertin (BI 425809) is an investigational drug and a glycine transporter 1 (GlyT1) inhibitor aimed at addressing the brain biology related to cognitive symptoms in schizophrenia (CIAS). Abnormalities in glutamatergic signaling downstream of neuronal NMDA receptors contribute to cognitive impairment in this condition. Enhancing NMDA receptor function could potentially improve synaptic plasticity and cognition. Glycine, an essential NMDA receptor co-agonist, is modulated by glycine transporters GlyT-1 and GlyT-2, which are located in presynaptic and astrocyte membranes. These transporters regulate glycine levels by taking it up into nerve terminals and adjacent glial cells, affecting synaptic cleft glycine concentration. By inhibiting these transporters, BI 425809 aims to increase glycine levels, thereby modulating NMDA receptor function. Administered orally, this potent and selective GlyT1 inhibitor is also under investigation for Alzheimer's disease. However, early 2020 Phase II trial results did not support its continued development for this indication, and the focus has now shifted to schizophrenia, with multiple Phase III trials currently underway. Since schizophrenia, patients frequently ignore certain symptoms, such as cognitive impairment. Therefore, if approved, BI-425809 will be the first approved pharmacotherapy for the treatment of CIAS. Ulotaront (SEP-363856), developed by Sumitomo Pharma and Otsuka Pharmaceuticals, is a trace amine-associated receptor 1 (TAAR1) agonist with serotonin 5-HT1A agonist activity. It is a small-molecule oral agent that does not bind to dopamine D2 or serotonin 5-HT2A receptors. Sunovion discovered Ulotaront in collaboration with PsychoGenics using the in vivo phenotypic SmartCube platform and associated artificial intelligence algorithms. Ulotaront is currently in late-stage development for schizophrenia and generalized anxiety disorder (GAD) in Japan and as an adjunctive treatment for major depressive disorder, schizophrenia, and GAD in the US. Top-line results from Phase III DIAMOND 1 and DIAMOND 2 trials in schizophrenia have been released, but the Phase III DIAMOND 3 trial in the US has been halted. Sumitomo Pharma has also stopped a Phase III trial for schizophrenia in Japan and another Phase II/III trial in China, Japan, Taiwan, and the Philippines, citing business strategy reasons. Despite this, two Phase III trials are still ongoing. Recently, Otsuka and Sumitomo revised their licensing agreement, excluding SEP-4199 and SEP-378614. Under this revision, Otsuka gained exclusive rights from SMPA to develop, manufacture, and commercialize ulotaront worldwide. If Otsuka successfully develops and commercializes ulotaront, they will pay up to 30 million USD (approximately 4.5 billion yen) in milestones, along with royalties based on sales, without any upfront payment. Starting January 2024, Otsuka will cover the full cost of studies conducted by both Sumitomo Pharma Group and Otsuka, except for certain studies. KarXT (xanomeline–trospium) is an oral modulator targeting muscarinic receptors found in both the central nervous system (CNS) and various peripheral tissues. This proprietary product combines xanomeline, a novel muscarinic agonist, with trospium, an approved muscarinic antagonist, to preferentially stimulate muscarinic receptors in the CNS. As a dual M1/M4 muscarinic acetylcholine receptor agonist, KarXT aims to improve the positive, negative, and cognitive symptoms of schizophrenia. The US FDA has accepted Karuna Therapeutics' NDA for KarXT for adult schizophrenia treatment, with a PDUFA date of September 26, 2024. Additionally, KarXT is undergoing multiple Phase III trials as an adjunctive treatment with standard-of-care agents for schizophrenia and is being evaluated for psychosis treatment in Alzheimer's disease patients. Following Bristol Myers Squibb's acquisition of Karuna Therapeutics, Karuna is now a wholly-owned subsidiary of BMS. At the Annual Congress of the Schizophrenia International Research Society (SIRS) in April 2024 in Italy, BMS presented promising results from the latest interim analysis of the Phase III EMERGENT-4 open-label extension trial, showing KarXT's efficacy in reducing symptoms in adults with schizophrenia. BMS plans to continue discussions with the US FDA and will release more data from the EMERGENT program later this year. Discover more about drugs for schizophrenia in development @ Schizophrenia Clinical Trials The anticipated launch of these emerging therapies for schizophrenia are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the schizophrenia market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for schizophrenia is expected to grow from USD 2.6 billion in 2023 with a significant CAGR by 2034. This growth can be attributed to the introduction of upcoming therapies and the rising prevalence of the disease. The anticipated launch of these therapies is also expected to attract new entrants to the Schizophrenia market, resulting in increased competition and innovation. DelveInsight's latest published market report titled as Schizophrenia Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the schizophrenia country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The schizophrenia market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalent Cases of Schizophrenia Total Diagnosed Prevalent Cases of Schizophrenia Gender-specific Diagnosed Prevalent Cases of Schizophrenia Severity-specific Diagnosed Prevalent Cases of Schizophrenia The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM schizophrenia market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this schizophrenia market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the schizophrenia market. Also, stay abreast of the mitigating factors to improve your market position in the schizophrenia therapeutic space. Related Reports Schizophrenia Pipeline Schizophrenia Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key schizophrenia companies, including Otsuka Pharmaceutical Development & Commercialization, Inc., Gedeon Richter Ltd., Lyndra Therapeutics, Neurocrine Bioscience, Takeda Pharmaceutical Company, Memory Pharmaceuticals, Hoffmann-La Roche, Neurocrine Biosciences, Boehringer Ingelheim, Meiji Seika Pharma Co., Ltd., SK Life Science, Inc., Alkermes, Inc. , Solvay Pharmaceuticals, Mitsubishi Tanabe Pharma Corporation, SyneuRx International (Taiwan) Corp, BioXcel Therapeutics Inc, Cognitive Research Corporation, Amarex Clinical Research, Forum Pharmaceuticals Inc, Amneal Pharmaceuticals, LLC, Recognify Life Sciences, Accutest Research Laboratories (I) Pvt. Ltd., Eli Lilly and Company, Johnson & Johnson Pharmaceutical Research & Development, L.L.C, Janssen, LP, Delpor, Inc., Jiangsu Hansoh Pharmaceutical, Cerevel Therapeutics, LLC, Zogenix, Inc., Luye Pharma, Reviva Pharmaceuticals, Alkermes, Inc., Karuna Therapeutics, Autifony Therapeutics, Neumora Therapeutics, Adex Therapeutics, among others. Schizophrenia Epidemiology Forecast Schizophrenia Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and schizophrenia epidemiology trends. Dementia Market Dementia Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key dementia companies, including Hoffmann-La Roche, Forest Laboratories, Inc., Janssen Pharmaceuticals, Inc., Merck and Co., Inc., Novartis, among others. Bipolar Depression Market Bipolar Depression Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key bipolar depression companies, including Intra-Cellular Therapies, Sunovion Pharmaceuticals, COMPASS Pathways, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

Phase 3Phase 2Clinical ResultDrug ApprovalLicense out/in

13 Jun 2022

·www.biospace.com

Cortexyme Appoints June Bray to its Board of Directors

June 13, 2022 12:00 UTC SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Cortexyme, Inc. (Nasdaq: CRTX), a clinical-stage biopharmaceutical company focused on rare and degenerative diseases, today announced the appointment of June Bray, a pharmaceutical industry veteran and global drug development and regulatory process expert, to the company’s Board of Directors. “We are very pleased to welcome a seasoned pharmaceutical and global regulatory expert of June Bray’s caliber to our Board of Directors,” said David Lamond, chairperson of Cortexyme’s Board of Directors. “With more than four decades of pharmaceutical industry experience, we look forward to her valuable contribution and perspective across multiple therapeutic areas.” “I am excited to join Cortexyme’s Board of Directors as the company works to efficiently and effectively advance its current clinical stage therapeutics, in addition to expanding its development pipeline in strategic ways,” said June Bray. “I look forward to supporting the new leadership team as they work to establish a clear roadmap for driving the company’s clinical stage and discovery pipeline, and in the evaluation of new business development opportunities.” To the Cortexyme Board of Directors, Ms. Bray brings more than forty years of extensive U.S. and global regulatory experience in the healthcare industry and a proven track record of successful regulatory interactions with health authorities which have led to the approval of 32 NDAs in the U.S. and multiple international approvals. She most recently served as Senior Vice President, Global Regulatory Affairs and Medical Writing at Allergan, where she was responsible for regulatory strategies on development projects and lifecycle management in all therapeutic areas, including psychiatry and neurology. During her tenure, she led numerous NDA approvals, including Namenda XR®, Namzaric®, Vraylar®, and Ubrelvy®. Previously, Ms. Bray served as Vice President, Regulatory Affairs at Organon (now Merck), where she led regulatory activities for development and marketed products, including the NDA for Saprhis® (asenapine) for the treatment of schizophrenia and bipolar disorder. Earlier in her career, Ms. Bray held numerous roles of increasing responsibility over a 25-year period at Berlex Laboratories, Inc. (now Bayer HealthCare Pharmaceuticals). She began her pharmaceutical career in sterile manufacturing at Hoechst-Roussel Pharmaceuticals (now Sanofi-Aventis). Ms. Bray holds a B.S. in Pharmacy from the University of Rhode Island and an M.B.A in Pharmaceutical Marketing from Fairleigh Dickinson University. About Cortexyme Cortexyme, Inc. (Nasdaq: CRTX) is a clinical stage biopharmaceutical company focused on rare and degenerative diseases. The company’s innovative pipeline includes a precision bone growth molecule and drug-targeting platform to treat rare skeletal diseases, bone cancer and injury, in addition to small molecule therapeutics targeting the infectious pathogen P. gingivalis’ role in degenerative disease progression, including for indications such as periodontal disease, oral potentially malignant disorders, and Alzheimer’s disease, among others. To learn more about Cortexyme, visit or follow @Cortexyme on Twitter.

Small molecular drug

23 May 2007

·www.pharmatimes.com

Organon's asenapine shows promise in Phase III trials

Organon, the healthcare business of The Netherlands’s Akzo Nobel, has presented promising late-stage data for its experimental antipsychotic asenapine. Phase III data, presented at the American Psychiatric Association's annual meeting in San Diego, revealed that asenapine significantly improved acute mania symptoms in patients with bipolar I disorder compared to placebo, and had a lower risk of weight gain than Eli Lilly's Zyprexa (olanzapine). As part of the three-week study, 488 patients with bipolar I disorder experiencing mania or a mixed episode were randomised to three weeks of treatment with either asenapine twice-daily, Zyprexa once-daily, or placebo. 3.1% of patients who received asenapine reported weight gain, compared with 6.9% of those taking the Lilly drug and 1% of patients in the placebo group. 61% of patients taking asenapine reported adverse events, most of which were mild to moderate, including sedation, dizziness, headache and fatigue, compared with 53% on of those taking Zyprexa -- whose reported side effects included sedation, dry mouth and weight gains -- and 36 percent of those given placebos Robert Hirschfeld, at the Department of Psychiatry and Behavioural Sciences at The University of Texas, said that the results of this trial suggest that “asenapine is an attractive option for the acute treatment of mania because of its rapid onset of action and modest side effect profile.” However Organon was keen to highlight the brevity of the study and more trials need to be done. The drug is also being studied in schizophrenia, and late-stage results for this indication are expected later this year. The data is a boost for Organon which was jointly developing asenapine with Pfizer before the drugs giant pulled out of the agreement in November, citing commercial interests. The compound is regarded as the most promising in the pipeline at Organon, which is set to be acquired by Schering-Plough.

100 Deals associated with Asenapine Maleate

External Link

KEGG	Wiki	ATC	Drug Bank
D02995	Asenapine Maleate	N05AH05	DB06216

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bipolar I disorder	EU	Organon NV	01 Sep 2010
Bipolar I disorder	IS	Organon NV	01 Sep 2010
Bipolar I disorder	LI	Organon NV	01 Sep 2010
Bipolar I disorder	NO	Organon NV	01 Sep 2010
Mania	EU	Organon NV	01 Sep 2010
Mania	IS	Organon NV	01 Sep 2010
Mania	LI	Organon NV	01 Sep 2010
Mania	NO	Organon NV	01 Sep 2010
Bipolar Disorder	US	Allergan Sales LLC	13 Aug 2009
Schizophrenia	US	Allergan Sales LLC	13 Aug 2009

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Stuttering	Phase 3	US	Merck Sharp & Dohme Corp.	01 Sep 2012
Schizophrenia, Treatment-Resistant	Phase 3	-	Organon & Co.	05 Apr 2011
Paranoid Schizophrenia	Phase 3	-	Organon & Co.	28 Sep 2010
Schizophrenia, Disorganized	Phase 3	-	Organon & Co.	28 Sep 2010
Psychotic Disorders	Phase 3	-	Organon & Co.	01 Feb 2006
Schizoaffective disorder	Phase 3	-	Organon & Co.	04 Sep 2003

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02876900 (HP-3070, CTgov)	Phase 3	Schizophrenia	617	Placebo+Low Dose Asenapine maleate transdermal patch (Low Dose Asenapine Maleate Patch)	osqjhpldem(asbcquhswu) = rpctagohnk scorualdxr (pvbkxqmavy, ynlzsfqloz - jlvksnbiqs) View more	-	27 Mar 2020
				Placebo+High Dose Asenapine maleate transdermal patch (High Dose Asenapine Maleate Patch)	osqjhpldem(asbcquhswu) = dabrsicxby scorualdxr (pvbkxqmavy, hakjypikhb - yntarerveg) View more
NCT00145470 (P05844 \| A7501008, CTgov)	Phase 3	Bipolar Disorder	326	Placebo (Placebo)	khkrtavhnj(bneabetgkc) = ixvutasayx wyecviobxt (blnxwuaqek, zzdvcytodn - ymfotwclay) View more	-	16 Sep 2019
				Asenapine (Asenapine)	khkrtavhnj(bneabetgkc) = niblqvoltc wyecviobxt (blnxwuaqek, upmaevubae - qhavpnmhcp) View more
NCT01396291 (P06384, Pubmed \| Am J Psychiatry) Manual	Phase 3	Bipolar I disorder Maintenance	253	Asenapine	ujyvjstbxa(jfqywxllpd) = statistically significantly longer for asenapine- than placebo-treated subjects. jrakjzfbpk (ozelvcziqs ) View more	Positive	01 Jan 2018
				Placebo
NCT01617187 (Pubmed \| CNS Spectr)	Phase 3	Acute schizophrenia	360	Asenapine 5 mg bid	bltrdbysjx(eazlduitju): points = -5.5 (95% CI, -10.1 to -1.0), P-Value = 0.0356	Positive	01 Aug 2017
				Placebo
NCT01349907 (P05898, Pubmed \| Paediatr Drugs)	Phase 3	Bipolar I disorder	321	Asenapine	uboytdmmse(pxinhfaydi) = 34.8 % of patients experienced clinically significant weight gain (≥7 % increase) eofimcudgq (nfummhjkpj ) View more	-	01 Oct 2016
NCT01098110 (Pubmed \| Psychopharmacology (Berl))	Phase 3	Acute schizophrenia	532	Asenapine 5 mg bid	ookgzzztwc(srigszjzte) = isdlxbzjpr yebgdmjsbe (zxrjgzoorr, ±2.65)	Positive	01 Jul 2016
				Asenapine 10 mg bid	ookgzzztwc(srigszjzte) = pcehqlnqic yebgdmjsbe (zxrjgzoorr, ±2.89)
NCT01142596 (P06125, CTgov)	Phase 3	Schizophrenia	201	Placebo+Asenapine (Placebo/Asenapine)	tzufacpeyc(iuxvogqhyn) = wtgtqjqcpk pwlhzgsybt (pjvzmcpicp, djjgdouwab - oqprwuqlig) View more	-	18 May 2016
				Asenapine (Asenapine 5/10 mg BID)	tzufacpeyc(iuxvogqhyn) = lnpgshotqk pwlhzgsybt (pjvzmcpicp, szeqsovozm - scufuiiwrh) View more
NCT01400113 (CTgov)	Phase 4	Agitation	120	Asenapine (Asenapine)	wpqaihjlhl(fmdjmyxntt) = ptbujzojpv gtklibqzrm (ydkcsefien, qoxocmuent - ajoulrbgwp) View more	-	16 May 2016
				Placebo (Placebo)	wpqaihjlhl(fmdjmyxntt) = uueldnvmhf gtklibqzrm (ydkcsefien, hahjmbhdiz - ykggfpdrge) View more
NCT01244815 \| NCT01349907 (Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder, Pubmed \| J Am Acad Child Adolesc Psychiatry)	Phase 3	Bipolar I disorder	403	Placebo	ffrfhirliu(woffyofiyu) = thpbcqqopg etvyaalmkq (qucvjklevi ) View more	Positive	01 Dec 2015
				Asenapine 2.5 mg b.i.d.	aruzfnxwrq(hwjyysfofd) = ufaaxblmni nqqiqpwksp (ounborlsqv ) View more
NCT01670019 (CTgov)	Phase 4	Depressive Disorder, Major	46	Asenapine 5-20 mg daily (Asenapine 5-20 mg Daily)	uxhwkaqdjc(omeryydhep) = ibfqzsjhyu hscllagzwt (nbgajddnpm, ldtlppwikz - zrrfpdmsam) View more	-	01 Oct 2015
				Placebo 1-4 tablets daily (Placebo 1-4 Tablets Daily)	uxhwkaqdjc(omeryydhep) = yewdzkdagk hscllagzwt (nbgajddnpm, lwyedyapfg - zulzaugewe) View more

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