A Phase III, Randomized, Double Blind, Active Controlled, Prospective, Parallel Group, Comparative, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination of Dextromethorphan Hydrobromide plus Bupropion Hydrochloride Extended Release Tablets versus Bupropion Hydrochloride Sustained Release Tablets in Adult Patients with Major Depressive Disorder (MDD). ?

Start Date16 Jun 2023

Sponsor / Collaborator

Exemed Pharmaceuticals

CTRI/2022/11/047227

/ RecruitingPhase 4

A Multicentric, Phase IV Clinical Trial to Evaluate Safety and Efficacy Of Fixed Dose Combination Of Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Sustained Release Suspension in Patients Suffering from Dry Cough Associated with Sneezing and/ or Running Nose and/ or Throat Irritation

Start Date21 Nov 2022

Sponsor / Collaborator-

CTR20212976

/ CompletedNot Applicable

氢溴酸右美沙芬硫酸奎尼丁胶囊 20mg/10mg 随机、开放、单剂量、两制剂、双交叉空腹及餐后状态下人体生物等效性试验

[Translation] A randomized, open-label, single-dose, two-formulation, double-crossover bioequivalence study of dextromethorphan hydrobromide and quinidine sulfate capsules 20 mg/10 mg in humans under fasting and fed conditions

主要目的：研究健康受试者在空腹及餐后状态下，单次分别口服受试制剂氢溴酸右美沙芬硫酸奎尼丁胶囊（规格：20mg/10mg）与参比制剂氢溴酸右美沙芬硫酸奎尼丁胶囊（商品名：Nuedxta®，规格：20mg/10mg），考察两制剂在健康人体内的生物等效性，为正式试验的样本量计算提供依据。次要目的：观察受试制剂氢溴酸右美沙芬硫酸奎尼丁胶囊和参比制剂Nuedxta®在健康受试者中的安全性。

[Translation]

Primary objective: To study the bioequivalence of the two preparations in healthy subjects by taking a single oral dose of the test preparation dextromethorphan hydrobromide quinidine sulfate capsules (specification: 20mg/10mg) and the reference preparation dextromethorphan hydrobromide quinidine sulfate capsules (trade name: Nuedxta®, specification: 20mg/10mg) in the fasting and postprandial state, and to provide a basis for the sample size calculation of the formal trial. Secondary objective: To observe the safety of the test preparation dextromethorphan hydrobromide quinidine sulfate capsules and the reference preparation Nuedxta® in healthy subjects.

Start Date19 Dec 2021

Sponsor / Collaborator

Zhuhai Rundu Pharmaceutical Co., Ltd.

100 Clinical Results associated with Dextromethorphan Hydrobromide/Quinidine Sulfate

100 Translational Medicine associated with Dextromethorphan Hydrobromide/Quinidine Sulfate

100 Patents (Medical) associated with Dextromethorphan Hydrobromide/Quinidine Sulfate

Literatures (Medical) associated with Dextromethorphan Hydrobromide/Quinidine Sulfate

02 Jan 2024·Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration

ALSUntangled #71: Nuedexta

Review

Author: Brown, Andrew ; Li, Xiaoyan ; Bromberg, Mark ; Beauchamp, Morgan ; Staats, Kim ; Sun, Yuyao ; Carter, Greg ; Barkhaus, Paul ; Benatar, Michael ; Mascías Cadavid, Javier ; Jhooty, Sartaj ; Ennist, Dave ; Wicks, Paul ; Bedlack, Richard ; Bertorini, Tulio ; Pattee, Gary

Nuedexta is a combination of dextromethorphan hydrobromide and quinidine sulfate and was approved by the Food and Drug Administration (FDA) in 2010 to treat pseudobulbar affect (PBA). There have since been anecdotal case reports of bulbar function improvements after Nuedexta treatment. Here, we review the off-label use of Nuedexta for improving bulbar function in people with ALS. Nuedexta has plausible mechanisms for protecting brain stem motor neurons via its effects on S1R and glutamate excitotoxicity. Recent clinical trials support that Nuedexta can improve bulbar function in PALS, with or without PBA. Nuedexta causes mild to moderate side effects. Based on this information, we support considering Nuedexta treatment for bulbar dysfunction in ALS patients with or without PBA.

01 Jan 2024·AIMS Neuroscience

Assessing the efficacy of amyotrophic lateral sclerosis drugs in slowing disease progression: A literature review

Review

Author: Wen, Jimmy ; Ansari, Zaid ; Chen, Vincent ; Ansari, Ubaid ; Nadora, Dawnica ; Alam, Meraj ; FitzPatrick, Megan ; Muttalib, Zohaer ; Taguinod, Isabel ; Lui, Forshing

<abstract> <p>Amyotrophic lateral sclerosis (ALS) is a fatal and intricate neurodegenerative disease that impacts upper and lower motor neurons within the central nervous system, leading to their progressive destruction. Despite extensive research, the pathogenesis of this multifaceted disease remains elusive. The United States Food and Drug Administration (FDA) has granted approval for seven medications designed to address ALS and mitigate its associated symptoms. These FDA-sanctioned treatments are Qalsody, Relyvrio, Radicava, Rilutek, Tiglutik, Exservan, and Nuedexta. In this review, the effects of these seven drugs on ALS based on their mechanism of action, dosing, and clinical presentations are comprehensively summarized. Each medication offers a distinct approach to manage ALS, aiming to alleviate the burdensome symptoms and slow the disease's progression, thereby improving the quality of life for individuals affected by this neurological condition. However, despite these advancements in pharmaceutical interventions, finding a definitive cure for ALS remains a significant challenge. Continuous investigation into ALS pathophysiology and therapeutic avenues remains imperative, necessitating further research collaborations and innovative approaches to unravel the complex mechanisms underlying this debilitating condition.</p> </abstract>

01 Jan 2023·Applied Microbiology and Biotechnology

Biological aspects of nitrogen heterocycles for amyotrophic lateral sclerosis

Review

Author: Roopan, Selvaraj Mohana ; Pouthika, Kamalanathan ; Madhumitha, Gunabalan ; Manjupriya, Ravichandran

Amyotrophic lateral sclerosis (ALS) is a rare, cumulative neurological deteriorating disease that disturbs the neurons (nerve cells) that control voluntary muscle movement (those muscles we choose to move). Currently, the Food and Drug Administration (FDA) approved drugs such as Radicava, Rilutek, Tiglutik, Exservan, and Nuedexta to treat ALS. Given the wide range of pharmaceutical applications of heterocyclic compounds, especially those containing the nitrogen ring systems such as pyridine, pyrimidine, and indole. These molecular frameworks have piqued the interest of medicinal chemists for further investigation in a variety of diseases. We have found several review works done on this research topic. Until now, no reviews published on the nitrogen heterocycles for treating ALS. This review examines the major causes of ALS, a brief history of medications that have been used to treat it so far, and the most recent breakthroughs in nitrogen ring systems for treating ALS. The novelty of this study provides insights on several effective synthetic techniques for nitrogen-based heterocyclic medications that operate as potent anti-inflammatory treatments and guard against ALS. KEY POINTS: • Pharmacological activity of heterocyclic compounds. • Neurodegenerative diseases and their drawbacks are discussed in detail. • Recent survey of nitrogen heterocycles in treating ALS disease are highlighted.

News (Medical) associated with Dextromethorphan Hydrobromide/Quinidine Sulfate

24 May 2024

·www.fiercepharma.com

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

AcquisitionPhase 3Cell TherapyLicense out/inADC

23 May 2024

·www.pharmaceutical-technology.com

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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British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country * UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo By downloading this case study, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy Tick here to opt out of curated industry news, reports, and event updates Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. 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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Bissau (+245) Guyana (+592) Haiti (+509) Honduras (+504) Hong Kong (+852) Hungary (+36) Iceland (+354) India (+91) Indonesia (+62) Iran (+98) Iraq (+964) Ireland (+353) Israel (+972) Italy (+39) Jamaica (+1876) Japan (+81) Jordan (+962) Kazakhstan (+7) Kenya (+254) Kiribati (+686) Korea North (+850) Korea South (+82) Kuwait (+965) Kyrgyzstan (+996) Laos (+856) Latvia (+371) Lebanon (+961) Lesotho (+266) Liberia (+231) Libya (+218) Liechtenstein (+417) Lithuania (+370) Luxembourg (+352) Macao (+853) Macedonia (+389) Madagascar (+261) Malawi (+265) Malaysia (+60) Maldives (+960) Mali (+223) Malta (+356) Marshall Islands (+692) Martinique (+596) Mauritania (+222) Mayotte (+269) Mexico (+52) Micronesia (+691) Moldova (+373) Monaco (+377) Mongolia (+976) Montserrat (+1664) Morocco (+212) Mozambique (+258) Myanmar (+95) Namibia (+264) Nauru (+674) Nepal (+977) Netherlands (+31) New Caledonia (+687) New Zealand (+64) Nicaragua (+505) Niger (+227) Nigeria (+234) Niue (+683) Norfolk Islands (+672) Northern Marianas (+670) Norway (+47) Oman (+968) Palau (+680) Panama (+507) Papua New Guinea (+675) Paraguay (+595) Peru (+51) Philippines (+63) Poland (+48) Portugal (+351) Puerto Rico (+1787) Qatar (+974) Reunion (+262) Romania (+40) Russia (+7) Rwanda (+250) San Marino (+378) Sao Tome & Principe (+239) Saudi Arabia (+966) Senegal (+221) Serbia (+381) Seychelles (+248) Sierra Leone (+232) Singapore (+65) Slovak Republic (+421) Slovenia (+386) Solomon Islands (+677) Somalia (+252) South Africa (+27) Spain (+34) Sri Lanka (+94) St. Helena (+290) St. Kitts (+1869) St. Lucia (+1758) Sudan (+249) Suriname (+597) Swaziland (+268) Sweden (+46) Switzerland (+41) Syria (+963) Taiwan (+886) Tajikstan (+7) Thailand (+66) Togo (+228) Tonga (+676) Trinidad & Tobago (+1868) Tunisia (+216) Turkey (+90) Turkmenistan (+7) Turkmenistan (+993) Turks & Caicos Islands (+1649) Tuvalu (+688) Uganda (+256) Ukraine (+380) United Arab Emirates (+971) Uruguay (+598) Uzbekistan (+7) Vanuatu (+678) Vatican City (+379) Venezuela (+58) Vietnam (+84) Virgin Islands - British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country * UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo By downloading this case study, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy Tick here to opt out of curated industry news, reports, and event updates Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Phase 3Drug ApprovalClinical ResultNDAPhase 2

22 May 2024

·www.fiercepharma.com

Otsuka pulls plug on Alzheimer's agitation drug after 2nd failed trial

After coming up short in a phase 3 trial for the second time, Otsuka has discontinued development of AVP-786. The drug was under investigation as a therapy for agitation that can accompany Alzheimer's disease. Otsuka Pharmaceutical is packing up an Alzheimer’s disease med after a phase 3 study failed to move the needle on measures of agitation associated with dementia. The results were originally issued in February, with Otsuka reporting that AVP-786 did not achieve the primary endpoint that measured a change in baseline on a rating scale of agitation compared with placebo. The therapy had been under development through Otsuka’s U.S. subsidiaries for agitation associated with dementia due to Alzheimer's. At the time, Otsuka did not have full details of the study to present. In announcing the termination of AVP-786 today, the Japanese pharma is still keeping those details under wraps. AVP-786 has traveled a bumpy path through the clinic, including failing a different phase 3 trial in 2019. That disappointment for the NMDA receptor antagonist came just months after Otsuka posted positive results for AVP-786 in a separate phase 3 trial. Otsuka acquired AVP-786 from CNS specialist Avanir Pharmaceuticals in a 2015 buyout worth $3.5 billion. Also coming in that deal was Nuedexta, a treatment approved in 2010 for pseudobulbar affect (PBA), a rare disorder that causes outbursts of laughing or crying that accompany some neurological conditions. Nuedexta uses the same chemical compound—dextromethorphan hydrobromide and quinidine sulfate—as AVP-786. Otsuka also investigated AVP-786 in early-stage trials for intermittent explosive disorder, schizophrenia and traumatic brain injury.

Phase 3AcquisitionClinical ResultDrug ApprovalPhase 2

100 Deals associated with Dextromethorphan Hydrobromide/Quinidine Sulfate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Dextromethorphan Hydrobromide/Quinidine Sulfate	N07XX59	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pseudobulbar Palsy	United States	Avanir Pharmaceuticals, Inc.	29 Oct 2010

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
pseudobulbar affect	Phase 3	Norway	Jenson Pharmaceutical Services Limited	24 Jun 2013
pseudobulbar affect	Phase 3	Iceland	Jenson Pharmaceutical Services Limited	24 Jun 2013
pseudobulbar affect	Phase 3	Liechtenstein	Jenson Pharmaceutical Services Limited	24 Jun 2013
pseudobulbar affect	Phase 3	European Union	Jenson Pharmaceutical Services Limited	24 Jun 2013
Amyotrophic Lateral Sclerosis	Phase 3	United States	Avanir Pharmaceuticals, Inc.	01 Jan 2001
Emotional lability	Phase 3	United States	Avanir Pharmaceuticals, Inc.	01 Jan 2001

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


P6-3.008 (AAN2024)	Not Applicable	Huntington Disease	20	Dextromethorphan/Quinidine 20mg/10mg	(mynqvaqwmd) = giylpbupui amnkvfegzu (aajhlfqzdl )	Negative	09 Apr 2024
				Placebo	(mynqvaqwmd) = avbdfinhly amnkvfegzu (aajhlfqzdl )
NCT01767129 (LID in PD, CTgov)	Phase 2	Dyskinesia, Drug-Induced \| Parkinson Disease	14	AVP-923-45 (AVP-923-45)	kplvklzzba(ivfdfgbkqc) = kluwjkzwkn nnrfrdkmkn (qbscsoblpa, pvnhbzkymj - qhkkxatfac) View more	-	29 Apr 2022
				Placebo (Placebo)	kplvklzzba(ivfdfgbkqc) = czhjjgemxd nnrfrdkmkn (qbscsoblpa, iqxsrmgfge - fqeqpdntdf) View more
NCT01584440 (CTgov)	Phase 2	Alzheimer Disease \| Agitation	220	Placebo (Placebo)	totbvlfbve(urdlvuhhji) = ewtxnmvhhw bcbcifqhlg (lekpoelgvu, aclomiwchf - tysmxwuyqt) View more	-	26 Nov 2021
				AVP-923-20 (AVP-923)	totbvlfbve(urdlvuhhji) = eizfxjivyl bcbcifqhlg (lekpoelgvu, bedyvimren - bqcndtlced) View more
NCT01324232 (PRIME, CTgov)	Phase 2	Multiple Sclerosis \| Neuralgia	209	Placebo (Placebo)	nbujfutjzs(sgdupaixjj) = vsccjmrpxf uroqvvrewv (fonfgibxpg, mfyajfmhoy - jyhzgbghdq) View more	-	22 Nov 2021
				AVP-923-20 (AVP-923-20)	nbujfutjzs(sgdupaixjj) = crrawchbjk uroqvvrewv (fonfgibxpg, ifnxoisxjw - tnwjxglyqj) View more
AAN2019	Not Applicable	pseudobulbar affect	86	Dextromethorphan-Quinidine (Nuedexta)	kbwdvvgurf(zytqpogxvr) = vwwvwpetis ulzxpesxsq (kpkyqfoyhx, -3.30 to 5.22)	-	09 Apr 2019
NCT01882829 (CTgov)	Phase 2	Depressive Disorder, Major \| Depressive Disorder, Treatment-Resistant	20	dextromethorphan/quinidine	(vaviqikhtv) = gxfwwxwfqf ngxktkzatq (lgrufniuwn, bhtsbrlper - cqravxljie) View more	-	11 Jun 2018
NCT02176018 (CTgov)	Phase 2	Migraine Disorders	76	Dextromethorphan (Nuedexta)	nnwdmtgblc(ddknomowrd) = zlwchzthiu dubgbfgilc (jcldwlbiav, qkgjhqqijj - ustsuscars) View more	-	03 Apr 2018
				Placebo (Placebo)	nnwdmtgblc(ddknomowrd) = lyhaaasghi dubgbfgilc (jcldwlbiav, oeeebzyprp - ctucxjwmbd) View more
NCT01630811 (Nuedexta, CTgov)	Phase 2	Autistic Disorder \| Autism Spectrum Disorder	13	Nuedexta (Nuedexta)	kwoounjthd(hcsrvsdyhb) = iymypfbhbf vgvzeqwdhc (kxqxrsxcfe, sgqdwmhjlc - idbkciakdc) View more	-	08 Dec 2017
				Placebo (Placebo)	kwoounjthd(hcsrvsdyhb) = nptxlkwwco vgvzeqwdhc (kxqxrsxcfe, hzccptutlc - zxjgtmcbyj) View more
NCT01799941 (PRISM II, Pubmed \| CNS Spectr)	Phase 4	pseudobulbar affect	134	Dextromethorphan/quinidine 20/10 mg	(seekssjxau) = obghjdhbwh odhputfwmy (ihxldozdsz ) View more	-	01 Dec 2016
NCT01799941 (PRISM II, AAN2016)	Phase 4	pseudobulbar affect	367	Dextromethorphan 20 mg/Quinidine 10 mg (NUEDEXTA®)	ajwdzhtpje(znmchadrhz) = oeiixbjujj uvtpgfsmoo (naefjbxphu )	Positive	05 Apr 2016

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