A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.

开始日期2020-09-03

申办/合作机构

Otsuka Pharmaceutical Development & Commercialization, Inc.

NCT04408755 / Recruiting临床3期

开始日期2020-07-08

申办/合作机构

Otsuka Pharmaceutical Development & Commercialization, Inc.

NCT03896945 / Terminated临床2/3期

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Negative Symptoms of Schizophrenia

This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786, as compared with placebo, for the treatment of negative symptoms of schizophrenia.

开始日期2019-02-15

申办/合作机构

Otsuka Pharmaceutical Development & Commercialization, Inc.

100 项与氘右美沙芬/硫酸奎尼丁相关的临床结果

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100 项与氘右美沙芬/硫酸奎尼丁相关的转化医学

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100 项与氘右美沙芬/硫酸奎尼丁相关的专利（医药）

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项与氘右美沙芬/硫酸奎尼丁相关的文献（医药）

2023-11-01·Current medicinal chemistry

Clinical Application and Synthesis Methods of Deuterated Drugs

Article

作者: Rao, Guo-Wu ; Zhang, Wen ; Xu, Xiao-Liang

Abstract::

Many drugs have adverse absorption, distribution, metabolism, and excretory (ADME) properties that prevent their widespread use or limit their use in some indications. In addition to preparation techniques and prodrug strategies, deuterium modification is a viable method for improving ADME properties. Deuterated drugs have attracted increasing attention from the pharmaceutical industry in recent years. To date, two deuterated drugs have been approved by the FDA. In 2017, austedo was approved by the FDA as a new drug for Huntington's disease in the United States, the first deuterium drug to be marketed worldwide. Recently (June 9, 2021), donafinil has been listed in China; this result has caused major pharmaceutical companies and the pharmaceutical industry to pay attention to deuterium technology again. In addition, BMS-986165, RT001, ALK-001, HC-1119, AVP-786 and other drugs are in phase III clinical studies, and some solid deuterium compounds have entered phase I and II clinical trials. The deuterium strategy has been widely used in pharmaceutical research and has become a hot spot in pharmaceutical research in recent years. In this paper, the research and development of deuterated drugs are reviewed, and the influence of deuterium modification on drugs, the advantages of deuterium strategies and the synthesis strategies of deuterated drugs are mainly introduced. Hoping to provide references for clinical application, the discovery of new deuterium chemical entities and research and development of new deuterated drugs.

2021-05-03·Expert opinion on pharmacotherapy3区 · 医学

AVP-786 as a promising treatment option for Alzheimer’s Disease including agitation

3区 · 医学

Review

作者: Velury, Divya ; Marx, Charlotte ; Grossberg, George T. ; Khoury, Rita ; Chakkamparambil, Binu ; Mirgati, Sidney

INTRODUCTION:

To date, there is no FDA-approved treatment for agitation in Alzheimer's disease (AD). Medications currently used off-label have modest clinical efficacy and serious side effects.

AREAS COVERED:

The authors review the pharmacology, mechanism of action, pharmacokinetics, efficacy, safety and tolerability data of AVP-786, for the treatment of agitation in AD.

EXPERT OPINION:

AVP-786, the deuterated form of dextromethorphan/quinidine (AVP-923) which is an approved treatment for Pseudo-Bulbar Affect, emerges as a promising and safe treatment for agitation in AD. Deuteration is an innovative technology that accelerates drug development by conducting faster and less costly clinical trials. No phase II trial was conducted with AVP-786 for the treatment of agitation in AD; the decision to expedite the development of this drug was based on a successful phase II study with AVP-923. Phase III trials with AVP-786 (TRIAD-1 and TRIAD-2) showed mixed findings probably due to the difference in study design. Future phase III studies should use innovative study designs such as the Sequential Parallel Comparison Design to mitigate high placebo response, and the Cohen-Mansfield Agitation Inventory for agitation assessment. They should also include positron emission tomography studies to assess occupancy of various receptors in the brain after AVP-786 is administered.

2021-01-01·Chronic stress (Thousand Oaks, Calif.)

Emerging Therapeutics Based on the Amino Acid Neurotransmitter System: An Update on the Pharmaceutical Pipeline for Mood Disorders

Review

作者: Hecking, Julia ; Davoudian, Pasha A. ; Wilkinson, Samuel T.

Mood disorders represent a pressing public health issue and significant source of disability throughout the world. The classical monoamine hypothesis, while useful in developing improved understanding and clinical treatments, has not fully captured the complex nature underlying mood disorders. Despite these shortcomings, the monoamine hypothesis continues to dominate the conceptual framework when approaching mood disorders. However, recent advances in basic and clinical research have led to a greater appreciation for the role that amino acid neurotransmitters play in the pathophysiology of mood disorders and as potential targets for novel therapies. In this article we review progress of compounds that focus on these systems. We cover both glutamate-targeting drugs such as: esketamine, AVP-786, REL-1017, AXS-05, rapastinel (GLYX-13), AV-101, NRX-101; as well as GABA-targeting drugs such as: brexanolone (SAGE-547), ganaxolone, zuranolone (SAGE-217), and PRAX-114. We focus the review on phase-II and phase-III clinical trials and evaluate the extant data and progress of these compounds.

项与氘右美沙芬/硫酸奎尼丁相关的新闻（医药）

2024-05-24

·FiercePharma

Fierce Pharma Asia—AstraZeneca eyes China's innovation, plots Singapore ADC plant; FDA rejects Hengrui's PD-1 drug

AstraZeneca made multiple headlines related to Asia this week. In addition, the FDA's rejection of Hengrui's PD-1 inhibitor made our news roundup. AstraZeneca's CEO wants to tap into China's innovation explosion. The company inked an oncology antibody deal with Harbour BioMed, and it plans to build a $1.5 billion ADC plant in Singapore. Hengrui and Elevar's proposed PD-1/VEGFR liver cancer combination has been rejected by the FDA. Plus more. 1. AstraZeneca to harness China's explosion of innovation to boost cell therapy R&D Innovation in China has “exploded,” and AstraZeneca plans to utilize its growing presence in the country to boost its R&D ambitions in cell therapy, CEO Pascal Soriot said during an investor event. Clinical development of cell therapy in China can “move much faster than anywhere else in the world,” he said. The British pharma has made several deals with Chinese companies over the past two years, including its $1 billion acquisition of Gracell Biotechnologies. 2. AstraZeneca pays $19M to Harbour BioMed's Nona for preclinical cancer antibodies Speaking of tapping into China’s innovation, AstraZeneca paid Harbour BioMed’s U.S. subsidiary Nona Biosceicnes $19 million upfront for preclinical monoclonal antibodies as potential targeted cancer therapies. Nona’s mice-based technology can produce heavy chain-only antibodies. The deal also includes $10 million in near-term payments and another $575 million in biobucks. 3. AstraZeneca places $1.5B bet on end-to-end ADC manufacturing in Singapore Meanwhile, AZ has unveiled plans to build a $1.5 billion antibody-drug conjugate manufacturing facility in Singapore. The site, expected to be operational by 2029, will become the company’s first end-to-end ADC production site. The move comes shortly after CEO Soriot said AZ is building separate drug supply chains for China and Western countries amid geopolitical risks. In recent years, Singapore has become a hot destination for biopharma manufacturing expansions. 4. FDA snubs another China-made PD-1 with rejection of Elevar, Hengrui's liver cancer combo The FDA has rejected Jiangsu Hengrui Pharma and Elevar Therapeutics’ respective applications for PD-1 inhibitor camrelizumab and the VEGFR inhibitor rivoceranib for use as a combination in first-line liver cancer. The FDA cited unresolved issues from the inspection of Hengrui’s manufacturing facility for camrelizumab as well as unfinished clinical trial site inspections. The partners aim to refile as soon as possible. 5. Takeda gets crafty with $1.2B biobucks deal to create molecular glues with Degron Takeda has signed a $1.2 billion biobucks deal with Shanghai’s Degron Therapeutics to work on molecular glue degraders for multiple targets in oncology, neuroscience and inflammation. Degron will use its GlueXplorer platform to find the new glues for therapeutic targets selected by Takeda. Degron has an in-house pipeline, including five early-stage molecular glue candidates in oncology. 6. Otsuka pulls plug on Alzheimer's agitation drug after 2nd failed trial Otsuka has officially ended development of AVP-786 after the NMDA receptor antagonist failed to move the needle in agitation associated with Alzheimer’s disease in a phase 3 trial. Otsuka obtained the drug from its $3.5 billion acquisition of Avanir Pharmaceuticals in 2015, which also gave the Japanese pharma Nuedexta for the rare disorder pseudobulbar affect. 7. Merck KGaA unit avoids DOJ prosecution after exposing scheme to divert drugs to China Two Florida residents pleaded guilty to conspiring to “fraudulently procure deeply discounted products” from Merck’s KGaA’s Sigma-Aldrich and ship them to China using faked export documents. The Department of Justice decided not to prosecute the German firm’s life science division, MilliporeSigma, because the company quickly disclosed the scheme and cooperated with the government’s investigation. 8. Chinese CDMO Asymchem expands footprint with deal to take over former Pfizer UK site China’s Asymchem Laboratories inked a deal to purchase a former Pfizer small molecule API pilot plant and part of its development labs in Sandwich, England. As part of a bigger cost-cutting scheme, Pfizer last year laid off 500 staffers at the plant. The purchase marks Asymchem’s first foray into Europe, and the firm expects to hire 100 workers by the end of the year, including many former Pfizer employees. Other News of Note: 9. Bristol Myers lines up Opdivo treatment in Pakistan, Rwanda and beyond as part of 10-year access campaign 10. Astellas, Yaskawa Electric Corporation ink pact to explore automated cell therapy production 11. Serum Institute deploys first doses of Oxford, Novavax-partnered malaria shot to Africa 12. No treachery here: Celltrion signs 'The Traitors' star Mollie Pearce for bowel disease campaign

并购临床3期细胞疗法引进/卖出抗体药物偶联物

2024-05-23

·Pharmaceutical Technology

Otsuka cuts development for AVP-786 following Phase III flop

Otsuka Pharmaceuticals ended clinical development for AVP-786 for agitation associated with Alzheimer’s disease following a negative Phase III readout. Credit: SOPA Images via Getty Images. Otsuka Pharmaceutical has axed the development of its dementia drug, AVP-786, following a disappointing Phase III readout (NCT03393520). Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. Thank you. You will receive an email shortly. Please check your inbox to download the Report. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. The Japanese company was investigating the therapy as a potential treatment for patients with agitation associated with dementia due to Alzheimer’s disease (AD). Otsuka completed the recent Phase III study in December 2023, reporting the official study results in February 2024. In the randomised, double-blind study, AVP-786 demonstrated no significant difference in the primary endpoint of mean change in the Cohen-Mansfield Agitation Inventory total score compared to the placebo. As per the 22 May press release, the decision to terminate the drug’s development followed a complete data analysis of the Phase III trial. AVP-786 is a dextromethorphan/quinidine combination that works by antagonising NMDA receptors and agonising Sigma-1 receptors amongst other effects. The therapy is a second-generation treatment, derived from Avanir Pharmaceuticals ’ Nuedexta (AVP-923). Otsuka acquired Avanir in a $3.5bn deal in December 2014. Nuedexta is a first-in-class dual-action glutamate inhibitor approved by the US Food and Drug Administration (FDA) for the treatment of pseudobulbar affect (PBA) associated with certain neurological conditions, including multiple sclerosis, in December 2010. Otsuka is the developer of the only FDA-approved treatment for the agitation associated with dementia due to AD, Rexulti (brexpiprazole), which received approval in November 2023. See Also: Pfizer starts $1.5bn cost-cutting initiative amidst declining Covid-19 revenues Patients and caregivers driving innovation in drug development According to GlobalData, there are seven therapies in Phase III trials for dementia associated with Alzheimer’s disease. This includes trials studying Auvelity— Axsome Therapeutics bupropion / dextromethorphan combination therapy, and Novo Nordisk ’s semaglutide. Novo Nordisk’s drug is approved for the treatment of weight loss and diabetes, under the brand names Wegovy and Ozempic. Pharma companies are actively trying to push the scope of these GLP-1 receptor agonists , with trials now exploring them as treatments for neurological disorders and fatty liver disease. Novo Nordisk predicts that the Phase III AD trial with semaglutide will be completed in October 2026. GlobalData is the parent company of Pharmaceutical Technology. As per the recent press release, Otsuka has declared that it will continue developing therapies for agitation associated with AD. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. Thank you. You will receive an email shortly. Please check your inbox to download the Report. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

临床3期上市批准临床结果申请上市临床2期

2024-05-23

·Pharmaceutical Technology

Pfizer starts $1.5bn cost-cutting initiative amidst declining Covid-19 revenues

The sales for Pfizer’s Covid products, Comirnaty and Paxlovid, decreased by 88% and 50% respectively in Q1 this year, compared to Q1 2022, as per the company’s financials. Image Credit: Andrii Yalanskyi / Shutterstock. Pfizer has unveiled another cost reduction programme, which is expected to run over multiple years and will result in savings of approximately $1.5bn by 2027. The move will include one-time expenditures, such as severance and implementation costs, of approximately $1.7bn. The company expects most of this to be recorded in its 2024 balance sheet but did caution investors to expect cash outlays up to 2026. Pfizer was sparse on details on the cost-cutting initiative, which will include “operational efficiencies, network structure changes, and product portfolio enhancements”. Following the announcement of the cost-saving initiative on 22 May, Pfizer’s share was up by 3.9% by the time the market closed later that day. The company’s market cap stands at $167.7bn. The demand for Covid-19 products has seen a significant decline over the past year. This has hit Pfizer hard, with the company’s revenue declining by 42% in 2023 , compared to the previous year. In October 2023, Pfizer started cost-saving measures , to save $1bn by the end of last year and an additional $2.5bn in 2024. In December, Pfizer added a $500m expense reduction plan to its cost reduction programme, aiming for $4bn in savings by this year. See Also: Otsuka cuts development for AVP-786 following Phase III flop AstraZeneca to establish $1.5bn ADC production site in Singapore Pfizer has two Covid-19 products in its catalogue – an antiviral pill Paxlovid (nirmatrelvir/ritonavir); and the Covid-19 vaccine Comirnaty, developed in partnership with BioNTech. The sales for both continue to decline – Comirnaty and Paxlovid sales decreased by 88% and 50% respectively in Q1 this year, compared to Q1 2023. To offset the profit decline from Covid-19 products, Pfizer has invested in expanding its pipeline. It doubled the size of its oncology pipeline with a $43bn acquisition of the antibody-drug conjugate specialist Seagen last year. Pfizer expects to develop eight or more “potential blockbusters” by 2030, as per a 29 February press release. The company also expects biologics to make a dent in revenues, increasing total oncology revenue from 6% in 2023 to 65% in 2030. Pfizer is also investigating therapies for weight loss, a high revenue-generating sector . While it had to discontinue the development of one of its glucagon-like peptide-1 receptor agonist (GLP-1-RA) candidates, lotiglipron, due to liver dysfunction, a Phase II trial (NCT04707313) with the second GLP-1-RA candidate, danuglipron, met the primary endpoint . The therapy induced weight reductions of between 8% and 13% after 32 weeks, and 5% and 9% after 26 weeks, compared to baseline.

临床2期疫苗并购临床结果

100 项与氘右美沙芬/硫酸奎尼丁相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11152	氘右美沙芬/硫酸奎尼丁	-	-

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
精神分裂症	临床3期	美国	Otsuka Pharmaceutical Development & Commercialization, Inc.	2019-02-15
精神分裂症	临床3期	保加利亚	Otsuka Pharmaceutical Development & Commercialization, Inc.	2019-02-15
精神分裂症	临床3期	波兰	Otsuka Pharmaceutical Development & Commercialization, Inc.	2019-02-15
精神分裂症	临床3期	波多黎各	Otsuka Pharmaceutical Development & Commercialization, Inc.	2019-02-15
躁动	临床3期	美国	Otsuka Pharmaceutical Development & Commercialization, Inc.	2015-07-23
躁动	临床3期	爱沙尼亚	Otsuka Pharmaceutical Development & Commercialization, Inc.	2015-07-23
躁动	临床3期	德国	Otsuka Pharmaceutical Development & Commercialization, Inc.	2015-07-23
躁动	临床3期	波兰	Otsuka Pharmaceutical Development & Commercialization, Inc.	2015-07-23
躁动	临床3期	葡萄牙	Otsuka Pharmaceutical Development & Commercialization, Inc.	2015-07-23
躁动	临床3期	波多黎各	Otsuka Pharmaceutical Development & Commercialization, Inc.	2015-07-23

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02442778 (CTgov)	临床3期	阿尔茨海默病引起的痴呆症 \| 躁动	522	Placebo (Placebo)	鏇醖願蓋遞廠鏇壓醖顧(淵糧艱鹽膚製鏇淵憲積) = 衊鑰鏇觸鹽糧齋製壓鹽憲齋淵餘廠顧遞鬱餘網 (願構憲鬱鑰獵糧遞獵鹽, 壓選鏇築憲蓋網積艱襯 ~ 製製夢觸憲齋構築淵鏇) 更多	-	2022-09-09
				AVP-786-18 (AVP-786-28)	鏇醖願蓋遞廠鏇壓醖顧(淵糧艱鹽膚製鏇淵憲積) = 鏇衊觸製顧範網憲觸網憲齋淵餘廠顧遞鬱餘網 (願構憲鬱鑰獵糧遞獵鹽, 齋願壓網衊淵築網選壓 ~ 鹽夢壓廠衊鑰鹽鬱夢獵) 更多
NCT03420222 (CTgov)	临床2期	破坏性、冲动控制及品行障碍	10	AVP-786 (AVP-786)	夢顧憲夢簾構選遞築選(網餘醖顧醖觸窪選顧糧) = 醖醖鏇齋齋鹹鹽鑰製網願鑰網選顧願鬱願觸醖 (襯蓋遞鏇夢淵鑰夢築顧, 觸遞鹽鹹繭壓鹹淵願衊 ~ 鬱顧顧廠壓鏇願鹽積願) 更多	-	2022-05-24
				placebo (Placebo)	夢顧憲夢簾構選遞築選(網餘醖顧醖觸窪選顧糧) = 鹽遞鬱衊鬱遞製鹽觸築願鑰網選顧願鬱願觸醖 (襯蓋遞鏇夢淵鑰夢築顧, 壓鑰衊繭蓋襯繭鬱餘願 ~ 鑰衊獵築選製鹹繭夢遞) 更多
NCT02534038 (CTgov)	临床2期	神经系统变性病 \| Crouzon综合征伴黑棘皮症	1	Placebo (Placebo)	鏇蓋淵願廠繭積鏇觸選(夢積艱選築夢蓋觸選餘) = 簾醖積餘鏇齋餘糧艱鹽網憲窪鑰憲襯鬱築鹹壓 (鹽蓋獵簾蓋獵鏇簾鬱選, 遞獵窪簾顧憲範選膚鏇 ~ 艱顧齋夢襯網齋壓膚夢) 更多	-	2020-10-26
				AVP-786 (AVP-786)	鏇蓋淵願廠繭積鏇觸選(夢積艱選築夢蓋觸選餘) = 憲鑰鬱鹹遞糧鹹獵願艱網憲窪鑰憲襯鬱築鹹壓 (鹽蓋獵簾蓋獵鏇簾鬱選, 夢鬱蓋構夢鹽壓鏇壓壓 ~ 淵鬱鏇襯遞製遞膚鏇艱) 更多