Attention Deficit Disorder With Hyperactivity

Study sheds light on a medical accessibility issue, the need for alternative or modified concussion assessment norms and the need for baseline testing PHILADELPHIA, March 28, 2024 /PRNewswire/ -- Schools and colleges across the country rely on Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) evaluations to assess and manage student-athlete concussions on the sidelines. However, this FDA-cleared tool is not recommended for student-athletes with neurodevelopmental disorders, who often score significantly lower than neurotypical individuals. New research published Feb. 13 in the Archives of Clinical Neuropsychology demonstrates the need for alternative or modified concussion assessment norms and the need for baseline testing for autistic athletes. "Given the findings of the current study and other recent studies, there is a clear need for ImPACT normative reference data specifically for student-athletes with autism spectrum disorder (ASD)," says Philip Schatz, PhD, principal investigator and professor of psychology at Saint Joseph's University. "The [neuropsychology] field needs to expand assessment and interpretation practices and procedures for people with ASD and related developmental conditions." Individuals with attention deficit hyperactivity disorder (ADHD), learning disorder (LD) and ASD are not included in normative reference data. This means when autistic athletes are assessed for a concussion, their data is compared to age- and gender-similar neurotypical individuals. Therefore, the utility and accuracy of widely used test measures like the ImPACT test decreases. Within the United States, the prevalence of ASD has increased over the past 20 years, from 1-in-150 children in 2000 to 1-in-36 children in 2020. Nearly 91% of adolescents with ASD reported liking sports and exercise, meaning the potential for concussive injuries in this population is high. Furthermore, previous research at Saint Joseph's University has shown that exercise can be helpful in treatment for ASD. "This is a medical accessibility issue," says Joseph McCleery, PhD, assistant professor of psychology and executive director of academic programs in the Kinney Center for Autism Education and Support and co-author on the study. "We need to make medicine more neurodivergence friendly. Research like this is an important first step toward fixing the problem." The research team points to the study as a critical first step in creating normative reference values for young athletes with ASD, and looks forward to continuing their research as part of a larger conversation of neuroinclusive care. "Athletes' developmental diagnosis was self-reported in this study," says Schatz. "Moving forward, we will need a more objective way of measuring this factor. We also will need to evaluate the utility of various concussion assessment measures. I look forward to the future, as it is important everyone receives effective concussion management, including people who are on the autism spectrum." SOURCE Saint Joseph's University

CUPERTINO, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced that Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva will be presenting at the 2024 Schizophrenia International Research Society (SIRS) Annual Meeting, to be held April 3-7, 2024, in Florence, Italy. Details for the Oral and poster presentations can be found below: Presentation Title: Brilaroxazine Phase 3 Recover Trial in Acute Schizophrenia Supports Efficacy, Safety, and Effects on NeuroinflammationOral Presentation Date and Time: Thursday, April 4, 2024 at 10:25 – 10:45 AM CETPoster Presentation Date and Time: Thursday, April 4, 2024 at 12:00 – 2:00 PM CETPoster Number: T291Presenter: Laxminarayan Bhat, Reviva PharmaceuticalsLocation: Florence, Italy About BrilaroxazineBrilaroxazine is an in-house discovered new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms. Positive topline data from the global Phase 3 RECOVER-1 trial in schizophrenia demonstrated the trial successfully met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains at week 4 with 50 mg of brilaroxazine vs. placebo with a generally well-tolerated side effect profile comparable to placebo and discontinuation rates lower than placebo. Positive data from a clinical drug-drug interaction (DDI) study investigating the potential effect of CYP3A4 enzyme on brilaroxazine in healthy subjects supports no clinically significant interaction when combined with a CYP3A4 inhibitor. Reviva believes that a full battery of regulatory compliant toxicology and safety pharmacology studies has been completed for brilaroxazine. Reviva intends to develop brilaroxazine for other neuropsychiatric indications including bipolar disorder, major depressive disorder (MDD) and attention-deficit/hyperactivity disorder (ADHD). Additionally, brilaroxazine has shown promising nonclinical activity for inflammatory diseases psoriasis, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) with mitigation of fibrosis and inflammation in translational animal models. Brilaroxazine has already received Orphan Drug Designation by the U.S. FDA for the treatment of PAH and IPF conditions. To learn more about the clinical and preclinical data available for brilaroxazine, please visit https://revivapharma.com/publications/.About RevivaReviva is a late-stage biopharmaceutical company that discovers, develops, and seeks to commercialize next-generation therapeutics for diseases representing unmet medical needs and burdens to society, patients, and their families. Reviva’s current pipeline focuses on central nervous system (CNS), inflammatory and cardiometabolic diseases. Reviva’s pipeline currently includes two drug candidates, brilaroxazine (RP5063) and RP1208. Both are new chemical entities discovered in-house. Reviva has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries. Forward-Looking StatementsThis press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act, as amended, including those relating to the Company’s 1-year open label extension (OLE) trial evaluating the long-term safety and tolerability for brilaroxazine in schizophrenia, the registrational Phase 3 RECOVER-2 trial, the Company’s expectations regarding the anticipated clinical profile of its product candidates, including statements regarding anticipated efficacy or safety profile, and those relating to the Company’s expectations, intentions or beliefs regarding matters including product development, clinical and regulatory timelines and expenses, planned or additional studies, planned or intended regulatory submissions, market opportunity, ability to raise sufficient funding, competitive position, possible or assumed future results of operations, business strategies, potential opportunities for development including partnerships, growth or expansion opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential, “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and the Company’s other filings from time to time with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Corporate Contact:Reviva Pharmaceuticals Holdings, Inc.Laxminarayan Bhat, PhD www.revivapharma.com Investor Relations Contact:LifeSci Advisors, LLCBruce Macklebmackle@lifesciadvisors.com Media Contact:Kristin Politikpoliti@lifescicomms.com(646) 876-4783

一款存在17年的原研药，倏然间在中国市场消失了。近期，有患者亲属在互联网平台反映，礼来治疗注意缺陷多动障碍（ADHD）的药物择思达（盐酸托莫西汀胶囊，Strattera），逐渐停止了在中国市场的供应，并称全国各地多家医院门口贴有“断货”通知。有的患者亲属在互联网购物平台上下单，其订单审核也显示不通过，或官方会直接来电表示缺货。一份在患者群中流传的关于择思达撤网申请说明显示：因礼来产品线战略调整，目前由礼来公司国外工厂LILLY DEL CARIBE Inc生产、礼来贸易有限公司作为总代的产品将逐渐停止向中国市场供应，最终在2024年1月底终止供应。停止供应的剂型均为胶囊，包装规格系10mg、25mg和40mg三种。图片来源于网络对此，E药经理人在多个线上购药平台进行求证，不少药店客服称，暂未收到正式断供通知，但近期突然出现了“哄抢”现象，某药店甚至称“一位客户直接一次性购入了100盒”。有的药店表示择思达胶囊目前库存所剩无几。此外笔者发现，择思达胶囊价格现在五花八门，有的已经炒至千元高价，有药店也感叹：“近期的确一天一个价了。”不仅是择思达，另有不少人发现，与择思达具备同一适应证的进口药专注达（原研厂家为强生），在医院也贴有“断货”通知。近三年，“撤出”中国市场的原研药不算少，每一次撤出，意味着对应不同的中国患者群体失去了一种药物选择。全球唯一获批用于治疗黏多糖贮积症IVA型（MPS IVA）的特效药唯铭赞退出中国市场，再往前，2021年，默沙东250亿重磅药国内批文注销，艾伯维曾经的明星丙肝药宣布“撤市”……细究原研药退出中国市场背后，原因不尽相同，如公司产品线要作出战略调整，销售难以覆盖成本，产品在公司内部发生了迭代升级，专利挑战，又或是受到外部激烈仿制药竞争，承受了较大的集采压力。“消失”的择思达择思达是一种高度选择性去甲肾上腺素重摄取抑制剂（SNRI），2002年7月获美国FDA批准上市，是全球首个被批准用于治疗注意缺陷多动障碍（ADHD）的非兴奋型药物。自2002年择思达在美国上市以来，全球范围内关于ADHD药物的研发一度陷入停滞。而副作用较小，具备良好的安全性和有效性的择思达则顺利打进了全球诸多市场。2007年，择思达（胶囊）在中国获批上市，与再普乐、百优解及欣百达并称为礼来在中国中枢神经产品线中的四大核心药品。2018年，择思达的口服溶液剂型也在中国获批，但彼时，不管是择思达，还是其余三款中枢神经产品，核心专利均已过专利保护期。好在，择思达在中国上市后得到了广泛的认可，不仅是《中国注意缺陷多动障碍防治指南(第二版)》非中枢兴奋剂类主要推荐药物，也是中国儿童ADHD防治指南将择思达作为治疗ADHD的主要推荐药物。公开数据显示，2021-2022年，托莫西汀在中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院终端的销售额保持在3亿元左右的水平。实际上，在2017年，择思达使用方法专利（US-05658590）正式到期。这意味着，关于该产品的胶囊剂和口服溶液剂的仿制品种都会在短时间内充斥市场。果不其然，这一年国内天方药业和江苏正大丰海两家企业的盐酸托莫西汀胶囊仿制药相继获得了生产批文；而到了次年，又有6款仿制药上市。此外，盐酸托莫西汀口服溶液对应的多款仿制药也陆续获批生产。不过，象征市场“萎缩”的钟声在2023年才敲响。在第九批集采中，盐酸托莫西汀的胶囊与口服溶液剂型同时入选，并成为此轮集采中最“卷”的品种之一。近20家企业入围，仅有9家企业最终拿到中标资格。值得注意的是，参与竞标的多数还为“光脚”企业，结果可想而知。往前回溯，择思达今年撤出中国市场的命运实则早有预兆。从礼来在中国的发展路径来看，一个关键的时间节点不可忽视——2018年，礼来计划重整及优化业务，瞄准利润更大的领域以促进业绩增长。彼时，礼来拟准备出售在中国专利过期药业务、往“新药”靠拢的信号明显。前脚出售了两款抗生素药权益，后脚对已过专利保护期的产品重视度进行调整，甚至“裁撤”，一切都是在为引入创新药物让位。调整后的礼来，在全球和中国市场的业务重心早已发生更迭，但在中国一直受到集采的影响。礼来年报显示，2022年因受到胰岛素集采影响，礼来中国市场收入同比下滑10%。不过在2023年的年报中，礼来中国区收入已经回归到了11%的增速水平。目前，礼来中国除了对糖尿病领域药物十分重视外，其在肿瘤领域的CKD4/6抑制剂阿贝西利表现颇为亮眼，2023年在全球大卖近40亿美元，其在中国区业绩持续攀升。不仅仅是中国，早已专利到期的老药择思达，似乎已经结束了它的历史使命，在礼来全球的财报中不再见其踪影。那些年退出中国市场的明星药物礼来择思达退出中国市场并非个例。近年来，还有不少明星药物似乎完成阶段性使命般，最终选择了退出中国市场。背后原因梳理来看，无外乎“商业前景不及预期”、“仿制药群起”、“同类更优产品冲击既有优势”、“内部产品更新迭代”等关键词。默沙东明星降糖药西格列汀片算是一大典型案例。2006年，作为全球第一款DPP-4抑制剂，默沙东西格列汀获FDA批准上市，用于单药或与二甲双胍、噻唑烷二酮类药物联合使用用于改善II型糖尿+病的血糖控制。由于长时间无竞争对手，西格列汀也算是风靡多年，销售额逐年攀升。该药进入中国市场则稍晚一些，直到2009年正式获批，成为国内市场上首个用于治疗2型糖尿病的DPP-4抑制剂。在国内甫一亮相，同样风光无两。转折发生在2020年，随着仿制药逐一登台亮相，占尽先发优势的西格列汀开始倍感压力。先是正大天晴首仿药率先进入市场，随后石药、东阳光西格列汀仿制药也相继获批，还有一众企业排队审批中……仿制药来势汹汹，西格列汀周遭销烟四起，面临的市场竞争也愈发激烈。这还仅是一击重锤，西格列汀原本引以为傲的“新”优势也逐渐减弱。随着更多的糖尿病新型疗法GLP-1受体激动剂、SGLT-2抑制剂陆续在国内获批上市并纳入医保，DPP-4抑制剂西格列汀除了被诸多仿制药“合围”外，还被更多糖尿病新疗法蚕食原本的市场空间，原有市场遭受挤压渐成定局。这逐渐演变成后来者所熟知的局面，默沙东适当调整企业战略，这款昔日明星药物选择退出中国，将资源给予更具竞争优势的产品。抛开竞争者来势汹汹，还有部分原因是“企业内部产品迭代”，从而自然演变至“淘汰更新”局面。艾伯维昔日明星丙肝药物奥比帕利退出中国市场这一案例或最为外界熟知。奥比帕利片联合达塞布韦钠片治疗方案于2017年首次在国内获批，2018年上市，作为一种全口服、无干扰素的治疗方案，用于治疗无肝硬化或伴代偿期肝硬化的基因1型慢性丙肝。虽然上市整体较为顺利，但遗憾的是，奥比帕利在2019年的医保谈判中失利。这还不算致命，更重要的是，该药物迭代产品也迅速上线了。2019年5月，艾伯维在中国市场推出了疗效更优的新一代丙肝产品——格卡瑞韦哌仑他韦片，用于治疗基因1、2、3、4、5或6型慢性丙型肝炎病毒感染的无肝硬化或代偿期肝硬化成人患者。这直接加速了奥比帕利在华的生命周期“衰退”，成为了2021年国内注销批文的重磅药物之一。彼时，艾伯维给出的官方回应同样验证了这一结局：新一代产品已在中国上市，奥比帕利的申请注销是全球同步。罕见病药物则面临着不一样的现实困境。拿全球唯一一款治疗黏多糖贮积症IVA型的药物“唯铭赞”为例，该药物将于今年5月退出中国市场，揭开了罕见病市场用药难的一角。退出原因从生产商百傲万里制药给患者的回复中可窥见一二：“复杂的市场准入规则使得药物的供应不可持续，特别是在罕见病治疗方面。尽管我们在过去几年中尽了最大努力，仍然没有促使药品进入医保报销体系，我们决定不再续签该产品的进口药品注册证。”它遇到的问题实则较为明确：一方面，患者本身数量少，国内黏多糖贮积症在患者组织处登记的人数约为400-500人。另一方面，根据病人症状和影像学表现的不同，该疾病有7种分型，一种分型的患者数量可能在100人左右。由此，患者人数少，加之药物价格高昂，患者负担不起，出于对市场前景考量、商业回报的不确定性权衡，企业战略性放弃部分市场似乎也在情理之中。就以2023年财报数据，百傲万里制药全年实现营收24.19亿美元，其中“唯铭赞”全球营收达7.01亿美元，却主要由美国和欧洲市场推动。对于这类罕见病药物，国内支付体系仍有不少需克服的挑战。随着同类产品层出不穷，仿制药陆续获批，原研药市场大不如前局面几乎无法逆转。由此，外资药企产品注销时有发生，命运相似者不在少数，还包括曾创下年销售15亿美金记录的诺华艾瑞宁。但无论这些明星药物是功成身退，还是被自然淘汰，或仅是暂时“出走”国内市场……都为时代留下了一笔鲜明的注脚。声明：本文3月27日首发于《E药经理人》（ID：eyjlr2013），经授权转载，如需二次转载请联系原作者。E药经理人媒体平台致力于成为医药行业意见领袖平台，记录和观察医药重大商业事件，展现行业的复杂与冲突，提供最前沿的思想洞见。 阅读原文，是昨天最受欢迎的文章哦