Katarzyna Śladowska, Paweł Kawalec, Tomasz Brzostek, Andrzej Pilc
{"title":"Potential use of psilocybin drugs in the treatment of depression.","authors":"Katarzyna Śladowska, Paweł Kawalec, Tomasz Brzostek, Andrzej Pilc","doi":"10.1080/14728214.2023.2264180","DOIUrl":"10.1080/14728214.2023.2264180","url":null,"abstract":"<p><strong>Introduction: </strong>Depression is a common disabling psychiatric disorder, which - in extreme cases - may lead to suicide if untreated or inadequately treated. Despite the availability of various treatments for depression, including pharmacotherapy, there is still a need to search for new agents with higher effectiveness and faster onset of action, especially for patients with treatment-resistant depression.</p><p><strong>Areas covered: </strong>A substance that has attracted considerable attention for nearly a decade is psilocybin, a natural psychedelic found in psilocybin mushrooms. In this study, we evaluated the efficacy and safety of psilocybin in the treatment of depression, based on pivotal randomized clinical trials. Moreover, we used findings from observational studies regarding recreational use. We also looked at ongoing clinical trials and discussed the registration status and clinical potential of the drug.</p><p><strong>Expert opinion: </strong>Clinical phase I-II trials published to date reported promising results for psilocybin in the treatment of patients with major depressive disorder and treatment-resistant depression, in a relatively short time after administration. However, before psilocybin is approved for use and administered to patients with depression, the results of large ongoing phase III clinical trials are needed to confirm its efficacy and safety and to change the way it is perceived by physicians and patients.</p>","PeriodicalId":12292,"journal":{"name":"Expert Opinion on Emerging Drugs","volume":" ","pages":"241-256"},"PeriodicalIF":3.4,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41196197","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Maxwell J Wagner, Charles P Daniel, Connor J Plaisance, Grant E Borne, Shahab Ahmadzadeh, Sahar Shekoohi, Alan D Kaye
{"title":"Apomorphine for Parkinson's disease: pharmacologic and clinical considerations.","authors":"Maxwell J Wagner, Charles P Daniel, Connor J Plaisance, Grant E Borne, Shahab Ahmadzadeh, Sahar Shekoohi, Alan D Kaye","doi":"10.1080/14728214.2023.2278677","DOIUrl":"10.1080/14728214.2023.2278677","url":null,"abstract":"<p><strong>Introduction: </strong>In Parkinson's disease, dopamine depletion in the basal ganglia leads to symptoms including bradykinesia, gait abnormalities, and cognitive impairment. Even with treatment, the disease course leads to decreases in the amount of dopamine produced and released into the synapse. As dopamine production falls and the treatment course is insufficient to match the metabolic supply and demand, acute 'off' periods develop that cause reemergence of symptoms. Apomorphine is used to reverse these 'off' periods and restore function in patients with Parkinson's. This review will provide clinicians a concise article to read to learn more about apomorphine and its appropriate utilization.</p><p><strong>Areas covered: </strong>The research discussed is focused on the history, pharmacokinetics, and mechanism of action of Apomorphine. Its utilization as a treatment for Parkinson's Disease and its comparison to currently utilized drugs is also discussed in this review. We focused on articles published on PubMed and Google Scholar within the last 10 years, but in some instances had to go as far back as 1951 to include early articles published about apomorphine.</p><p><strong>Expert opinion: </strong>The expert opinion section focuses on the ways in which apomorphine could be administered in the future to better promote utilization and increase tolerability.</p>","PeriodicalId":12292,"journal":{"name":"Expert Opinion on Emerging Drugs","volume":" ","pages":"275-281"},"PeriodicalIF":3.4,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71422179","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Emerging treatment for Sjögren's disease: a review of recent phase II and III trials.","authors":"Robert I Fox, Carla M Fox, Sara S McCoy","doi":"10.1080/14728214.2023.2209720","DOIUrl":"10.1080/14728214.2023.2209720","url":null,"abstract":"<p><strong>Introduction: </strong>Sjögren's Disease, SjD, is a systemic autoimmune disorder characterized by reduced function of the salivary and lacrimal glands. Patients suffer from dryness, fatigue, and pain and may present with or without extra-glandular organ involvement. Symptoms limit SjD patients' quality of life and are the most difficult to improve with therapy. SjD patients are heterogeneous and clustering them into biologically similar subgroups might improve the efficacy of therapies. The need for therapies that address both the symptoms and extra glandular organ involvement of SjD presents an unmet opportunity that has recently attracted a growing interest in the pharmaceutical industry.</p><p><strong>Areas covered: </strong>The goal of this report is to review recent phase II/III studies in SjD. To accomplish our goal, we performed a literature search for phase II/III studies and abstracts recently presented at conferences.</p><p><strong>Expert opinion: </strong>This review allows updates the reader on the multitude of recent phase II/III clinical trials. We speculate on how subtypes of SjD will drive future therapeutic targeting and inform pathogenesis.</p>","PeriodicalId":12292,"journal":{"name":"Expert Opinion on Emerging Drugs","volume":"28 2","pages":"107-120"},"PeriodicalIF":2.7,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10330372/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9763290","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Zheng Xian Thng, Albert John Bromeo, S Saeed Mohammadi, Anadi Khatri, Anh N T Tran, Amir Akhavanrezayat, Ngoc T T Than, Khiem S Nguyen, Woong-Sun Yoo, Azadeh Mobasserian, Christopher Chi Mong Or, Quan Dong Nguyen
{"title":"Recent advances in uveitis therapy: focus on selected phase 2 and 3 clinical trials.","authors":"Zheng Xian Thng, Albert John Bromeo, S Saeed Mohammadi, Anadi Khatri, Anh N T Tran, Amir Akhavanrezayat, Ngoc T T Than, Khiem S Nguyen, Woong-Sun Yoo, Azadeh Mobasserian, Christopher Chi Mong Or, Quan Dong Nguyen","doi":"10.1080/14728214.2023.2293049","DOIUrl":"10.1080/14728214.2023.2293049","url":null,"abstract":"<p><strong>Introduction: </strong>Uveitis is a heterogeneous group of ocular conditions characterized by inflammation of the uveal tract. It is a leading cause of blindness in developed countries and exerts significant psychological, social, and economic impact on both patients and the larger society. While there are numerous pharmacotherapy options, posterior segment noninfectious uveitis remains a significant challenge to treat due to its severity, chronicity, and high recurrence rates.</p><p><strong>Areas covered: </strong>The index review highlights the unmet needs of uveitis pharmacotherapy and its research and the shortcomings of existing ocular and systemic therapeutic options for noninfectious uveitis. The more promising novel ocular drug delivery methods and therapeutic targets/drugs are discussed, and evidence from the clinical trials is evaluated.</p><p><strong>Expert opinion: </strong>There has been incredible growth in the number of treatment options available to uveitis patients today, especially with the new generation of biologic drugs. Available evidence suggests that these newer options may be superior to conventional immunosuppressive therapies in terms of efficacy and side effect profiles. Further high-quality research and additional clinical trials will be needed to clarify their roles in the stepladder treatment approach of noninfectious uveitis.</p>","PeriodicalId":12292,"journal":{"name":"Expert Opinion on Emerging Drugs","volume":" ","pages":"297-309"},"PeriodicalIF":3.4,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138829132","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A review of emerging tyrosine kinase inhibitors as durable treatment of neovascular age-related macular degeneration.","authors":"Nikhil Das, Sameer Chaurasia, Rishi P Singh","doi":"10.1080/14728214.2023.2259790","DOIUrl":"10.1080/14728214.2023.2259790","url":null,"abstract":"<p><strong>Introduction: </strong>Current treatment for age-related macular degeneration poses a large burden on patients and the inability of patients to adhere to this immense burden can lead to worse visual outcomes. Novel treatments have been proposed to extend treatment intervals and reduce visit burden.</p><p><strong>Areas covered: </strong>This review article summarizes phase I and phase II clinical trials of tyrosine kinase inhibitors as durable treatment options for patient with neovascular age-related macular degeneration.</p><p><strong>Expert opinion: </strong>Tyrosine kinase inhibitors have shown substantial promise in reducing treatment burden while maintaining visual acuity and anatomic outcomes with favorable safety profiles. Several platforms have shown positive outcomes in initial trials and are currently moving toward phase III clinical trials.</p>","PeriodicalId":12292,"journal":{"name":"Expert Opinion on Emerging Drugs","volume":" ","pages":"203-211"},"PeriodicalIF":3.4,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41117971","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Silvia Salvatori, Benedetto Neri, Irene Marafini, Mattia Brigida, Giovanni Monteleone
{"title":"Emerging oral drug options for ulcerative colitis.","authors":"Silvia Salvatori, Benedetto Neri, Irene Marafini, Mattia Brigida, Giovanni Monteleone","doi":"10.1080/14728214.2023.2254686","DOIUrl":"10.1080/14728214.2023.2254686","url":null,"abstract":"<p><strong>Introduction: </strong>Despite the availability of a variety of therapeutic compounds and improved management strategies, one-third of UC patients with moderate-to-severe disease do not benefit from the existing treatments or experience drug-related side effects. This has boosted intensive research focusing on the development of new drugs for UC therapy. This article aims to summarize the available evidence on oral drugs, which are now being explored in clinical trials or are ready to enter the clinics.</p><p><strong>Areas covered: </strong>From May 15 to June 11, we searched on PubMed using the keywords 'oral drugs ulcerative colitis,' 'ulcerative colitis clinical trials,' 'UC phase 2 and 3 trials' excluding case reports, case series, phase 1 and 4 studies, and studies about approved therapies.</p><p><strong>Expert opinion: </strong>The findings discussed in this article suggest that the future treatment of UC patients will be probably characterized by the possibility of using various small-molecule drugs. All these new compounds, even those belonging to the same class, differ in terms of efficacy and safety. Identification of predictors of response could help optimize the efficacy and safety of these treatments, thus improving resource allocation through a pretreatment stratification of patients.</p>","PeriodicalId":12292,"journal":{"name":"Expert Opinion on Emerging Drugs","volume":" ","pages":"191-201"},"PeriodicalIF":3.4,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10159708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Claudio Tana, Francesco Cipollone, Maria Adele Giamberardino, Paolo Martelletti
{"title":"New drugs targeting calcitonin gene-related peptide for the management of migraines.","authors":"Claudio Tana, Francesco Cipollone, Maria Adele Giamberardino, Paolo Martelletti","doi":"10.1080/14728214.2023.2288334","DOIUrl":"10.1080/14728214.2023.2288334","url":null,"abstract":"<p><strong>Introduction: </strong>Significant advances in migraine research have contributed to the development of new drugs for the treatment of migraine. Monoclonal antibodies (mAbs) against Calcitonin Gene-Related Peptide (CGRP) or its receptor and CGRP receptor antagonists (gepants) have been associated with a good safety profile and resulted in an overall efficacy in reducing the number of monthly migraine days both in episodic and chronic forms of migraine.</p><p><strong>Areas covered: </strong>The results from main investigation studies (phase 2 or 3) of CGRP-targeting drugs (both anti-CGRP mAbs and gepants) are reported in this expert-opinion review.</p><p><strong>Expert opinion: </strong>The introduction of new drugs targeting CGRP is a significant breakthrough in the migraine field, and represents a new generation of therapeutic agents that are available to manage migraine. The evaluation of efficacy and safety in the long-term follow-up and the development of trials comparing the available drugs could improve the current knowledge. The economic sustainability of these drugs remains to be clarified, and a cost-cutting campaign should be promoted based on the high burden of migraine.</p>","PeriodicalId":12292,"journal":{"name":"Expert Opinion on Emerging Drugs","volume":" ","pages":"233-240"},"PeriodicalIF":3.4,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138298904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"How can we prevent diarrhea induced by systemic treatments in oncological patients? An evaluation of phase II trials.","authors":"Andrea Esposito, Paolo Bossi","doi":"10.1080/14728214.2023.2264182","DOIUrl":"10.1080/14728214.2023.2264182","url":null,"abstract":"","PeriodicalId":12292,"journal":{"name":"Expert Opinion on Emerging Drugs","volume":" ","pages":"213-216"},"PeriodicalIF":3.4,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41120970","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Emerging drugs for the treatment of moderately to severely active ulcerative colitis: review of phase II and III clinical trials.","authors":"Laura Neurath, Ferdinando D'Amico, Silvio Danese","doi":"10.1080/14728214.2023.2186399","DOIUrl":"https://doi.org/10.1080/14728214.2023.2186399","url":null,"abstract":"<p><strong>Introduction: </strong>Current therapeutic options for patients with ulcerative colitis comprise monoclonal antibodies against tumor necrosis factor (TNF), alpha4/beta7 integrin, and interleukin (IL)12/23 as well as small molecules such as tofacitinib, upadacitinib, ozanimod, and filgotinib. However, many patients fail to respond to these agents or have loss of response over time. Therefore, there is a large unmet clinical need for new therapeutic agents.</p><p><strong>Areas covered: </strong>Here, we review recent phase 2/3 studies in active ulcerative colitis and discuss preliminary data on the efficacy (clinical, endoscopic, and histologic remission) and safety of novel drugs including Janus kinase (JAK) inhibitors, IL23 blockers, integrin inhibitors, and S1P1R modulators.</p><p><strong>Expert opinion: </strong>We highlight the potential impact of these agents for the future therapeutic landscape of this disease with special emphasis on clinical impact, unmet needs, safety aspects, and advanced combination therapy.</p>","PeriodicalId":12292,"journal":{"name":"Expert Opinion on Emerging Drugs","volume":"28 1","pages":"27-42"},"PeriodicalIF":3.4,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9285522","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Emerging drugs for the treatment of type 1 diabetes mellitus: a review of phase 2 clinical trials.","authors":"Thinzar Min, Stephen C Bain","doi":"10.1080/14728214.2023.2188191","DOIUrl":"https://doi.org/10.1080/14728214.2023.2188191","url":null,"abstract":"<p><strong>Introduction: </strong>Despite therapeutic advances in the field of diabetes management since the discovery of insulin 100 years ago, there are still unmet clinical needs for people with type 1 diabetes mellitus (T1DM).</p><p><strong>Areas covered: </strong>Genetic testing and islet autoantibodies testing allow researchers to design prevention studies. This review discusses the emerging therapy for prevention of T1DM, disease modification therapy in early course of T1DM, and therapies and technologies for established T1DM. We focus on phase 2 clinical trials with promising results, thus avoiding the exhausted list of every new therapy for T1DM.</p><p><strong>Expert opinion: </strong>Teplizumab has demonstrated potential as a preventative agent for individuals at risk prior to the onset of overt dysglycemia. However, these agents are not without side effects, and there are uncertainties on long-term safety. Technological advances have led a substantial influence on quality of life of people suffering from T1DM. There remains variation in uptake of new technologies across the globe. Novel insulins (ultra-long acting), oral insulin, and inhaled insulin attempt to narrow the gap of unmet needs. Islet cell transplant is another exciting field, and stem cell therapy might have potential to provide unlimited supply of islet cells.</p>","PeriodicalId":12292,"journal":{"name":"Expert Opinion on Emerging Drugs","volume":"28 1","pages":"1-15"},"PeriodicalIF":3.4,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9292202","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}