Last update 19 Jun 2024

Dextromethorphan Hydrobromide Hydrate

Last update 19 Jun 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryDextromethorphan (DXM) is a synthetic analog of codeine, but unlike codeine, it is not a narcotic and does not have the same potential for abuse or addiction. DXM is an N-methyl-D-aspartate (NMDA) receptor antagonist, NMDA receptors are involved in pain perception and the regulation of mood, learning, and memory. DXM is a sigma-1 receptor agonist,Sigma-1 receptors are involved in many different functions, including pain perception, mood regulation, and neuroprotection. Dextromethorphan is commonly used as a cough suppressant, and it has also been investigated for its potential therapeutic effects in a variety of conditions, including neuropathic pain, depression, and addiction. Dextromethorphan was successfully tested in 1954 as part of US Navy and CIA-funded research on nonaddictive substitutes for codeine. It was approved by the FDA in 1958 as an over-the-counter antitussive.

Drug Type

Small molecule drug

Synonyms

Dextromethorphan Hydrobromide, Dextromethorphan Hydrobromide Cranules, Dextromethorphan Hydrobromide Granules

+ [29]

Target

NMDA receptor x σ1 receptor

Mechanism

NMDA receptor antagonists(Glutamate [NMDA] receptor antagonists), σ1 receptor agonists(Sigma opioid receptor agonists)

Therapeutic Areas

Respiratory Diseases

Active Indication

Dry coughCough

Inactive Indication-

Originator Organization

Shionogi Pharma Co., Ltd.

Active Organization

Guangzhou Baiyunshan Guang Hua Pharmacy Co., Ltd.Shionogi Pharma Co., Ltd.Tsuruhara Pharmaceutical Co. Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (01 Jan 1958),

Cough

Regulation-

Structure

Molecular FormulaC18H28BrNO2

InChIKeySTTADZBLEUMJRG-IKNOHUQMSA-N

CAS Registry6700-34-1

164

Clinical Trials associated with Dextromethorphan Hydrobromide Hydrate

NCT06383338 / Not yet recruitingPhase 1IIT

A Prospective Feasibility Study Investigating PhEnoconversion of CYP3A4, CYP2C19 and CYP2D6 Genotype in Paediatric and Adolescent and Young Adult patientS With an acUte diagnosiS of Hodgkin or Non-Hodgkin Lymphoma.

PEGASUS aims to test acceptability and feasibility of studying phenoconversion (the change in metabolism phenotype) using probe medications in a paediatric oncology patient population. The study will be conducted in patients (6-25 years of age) with Hodgkin lymphoma or non-Hodgkin lymphoma as exemplar cohort, but with the understanding that cancer-directed and supportive care medicines of the CYP3A4, CYP2C19, and CYP2D6 metabolic pathways are commonly utilised for the treatment of many paediatric, adolescent, young adult, and adult cancers.
The study involves administration of the probe medication at timepoints which align with pre-determined hospital visits for the treatment of lymphoma and subsequent blood draws to measure the metabolism of the probe medications.
The acceptability and feasibility of this study will inform future studies in phenoconversion within the paediatric cancer population to direct more personalised precision medicine.

Start Date01 Jul 2024

Sponsor / Collaborator

Murdoch Childrens Research Institute

IRCT20090117001556N158 / RecruitingPhase 2/3IIT

Dextromethorphan combination therapy with Fluoxetine in the treatment of moderate to severe OCD : A randomized, double-blind, placebo-controlled trial

Start Date21 May 2024

Sponsor / Collaborator

Tehran University of Medical Sciences

IRCT20100119003106N45 / RecruitingPhase 3IIT

Investigating the effectiveness of dextromethorphan on the sexual activity of women with sexual dysfunction

Start Date20 Apr 2024

Sponsor / Collaborator

Islamic Azad University

100 Clinical Results associated with Dextromethorphan Hydrobromide Hydrate

100 Translational Medicine associated with Dextromethorphan Hydrobromide Hydrate

100 Patents (Medical) associated with Dextromethorphan Hydrobromide Hydrate

2,641

Literatures (Medical) associated with Dextromethorphan Hydrobromide Hydrate

01 Mar 2024·Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy

Sensitive detection of dextromethorphan hydrobromide based on portable Raman spectrometer and CuO@AgNPs nano composite SERS substrate

Article

Author: Zhang, Fengming ; Liu, Xin ; Wang, Yuting ; Niu, Shiyue ; Yuan, Yue ; Liu, Jia ; Yang, Bin ; Bi, Shuyun

A highly sensitive surface-enhanced Raman spectroscopy approach was established for the detection of dextromethorphan hydrobromide (DXM) utilizing nano CuO modified silver nanoparticles (CuO@AgNPs) as substrate. Ultraviolet visible spectra (UV-vis), X-ray diffraction (XRD) and transmission electron microscopy (TEM) characterized the synthesized CuO@AgNPs. UV-vis and fourier transform infrared (FT-IR) were adopted to investigate the interaction between DXM and CuO@AgNPs. The optimal experimental conditions (the dosages of CuO@AgNPs and NaCl as well as mixing time) were explored. The enhancement factor (EF) was 1.71 × 10⁶. The linear relationship between SERS intensity and the concentration of DXM in the range of 67 - 1000 nmol L^-1 was obtained as I_SERS = 25.81 c + 40398.77, and the limit of detection (LOD) was 2.12 nmol L^-1 (S/N = 3). The interference of K⁺, Mg²⁺, Zn²⁺, Ca²⁺, Cu²⁺, Fe³⁺, glucose, HSA, L-tryptophan, soluble starch and ibuprofen were investigated. The method was successfully applied to test DXM in serum samples. The recovery was 99.06% - 101.51% with the relative standard deviation (RSD) of 0.74% - 3.87%.

02 Jan 2024·Amyotrophic lateral sclerosis & frontotemporal degeneration

Review

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

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·Journal of biochemical and molecular toxicology

Beneficial effect of 5‐HT1b/1d agonist on Parkinson's disease by modulating glutamate and reducing deposition of α‐synuclein

Article

Author: Tripathi, Alok Shiomurti ; Zaki, Magdi E. A. ; Fatima, Needa ; Alka ; Maurya, Rahul K ; Yasir, Mohammad ; Tripathi, Pankaj ; Mohapatra, Lucy ; Tripathi, Rina

Abstract:

The given investigation examined the neuroprotection role of 5‐HT1b/1d agonist in reserpine induced Parkinson's disease (PD) in male Wistar rats. PD was induced in rats by reserpine at 5 mg/kg ip for 3 days and thereafter the rats were provided with the following treatments for 4 days, zolmitriptan (ZLM) group (30 mg/kg ip); STD group (levodopa + carbidopa, 200 + 5 mg/kg ip); ZLM + GA group (zolmitriptan, 30 mg/kg ip and glutamic acid, 1.5 mg/kg); ZLM + DX group (zolmitriptan, 30 mg/kg ip and dextromethorphan, 20 mg/kg ip). All the groups were then assessed for cognitive and motor functions at the end of the protocol. Moreover, oxidative stress parameters and histopathological changes were observed in rats of all treatment groups. Deposition of α‐synuclein in the brain tissue was observed by silver staining. Data of this investigation revealed that motor and cognitive functions were improved in the ZLM‐treated group compared with the negative control group, which was observed to be reversed in ZLM + GA group. Treatment with ZLM ameliorated oxidative stress and histopathological changes in the brain tissue of PD rats. Further, ZLM reduced the deposition of α‐synuclein in PD rats, which reversed in ZLM + GA‐treated group. This study concludes by stating that 5‐HT1b/1d agonist can prevent neurodegeneration and reduce oxidative stress in PD rats. The probable underlying mechanism of such an effect of 5‐HT1b/1d agonist could be by regulating the deposition of α‐synuclein and reducing the expression of NMDA receptor.

News (Medical) associated with Dextromethorphan Hydrobromide Hydrate

28 May 2024

·www.globenewswire.com

Axsome Therapeutics Presents Data from Multiple Programs at the 2024 American Society of Clinical Psychopharmacology Annual (ASCP) Meeting

NEW YORK, May 28, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that data from its industry-leading portfolio of novel products for CNS disorders will be presented at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, being held May 28-31, 2024, in Miami Beach, Florida. The presentations include new data from post-hoc analyses of Auvelity® showing improvements in anhedonic symptoms that strongly correlate with improvements in daily function in patients with major depressive disorder (MDD) and data on the clinical profile of AXS-05 in treatment of Alzheimer’s disease agitation. Details for the presentation are as follows: Major Depressive Disorder Title: Effects of AXS-05 (Dextromethorphan-Bupropion) in Improving Anhedonia and Interest-Activity Symptoms of MDD and the Associated Improvements in Functional ImpairmentPresentation Date and Time: Wednesday, May 29, 11:15 a.m. – 1 p.m.Lead Author: Roger McIntyre, MD, Professor of Psychiatry and Pharmacology at the University of TorontoPoster Number: W17Location: Salon 4 Title: Real-World AXS-05 Patient Characteristics in Major Depressive DisorderPresentation Date and Time: Wednesday, May 29, 11:15 a.m. – 1 p.m.Lead Author: Andrew Muzyk, MD, Associate Professor of the Practice of Medical Education at Duke UniversityPoster Number: W40Location: Salon 4 Alzheimer’s Disease Agitation Title: Clinical Profile of AXS-05 (Dextromethorphan-Bupropion) in Treating Alzheimer’s Disease Agitation (ADA): Results From The Phase 2/3 Development ProgramPresentation Date and Time: Wednesday, May 29, 11:15 a.m. – 1 p.m.Lead Author: Jeffrey Cummings, MD, ScD, Vice Chair of Research, UNLV Department of Brain HealthPoster Number: W47Location: Salon 4 Cognition Title: Solriamfetol Improves Cognitive Performance in Preclinical Models of Sleep Apnea and in a Randomized Placebo-controlled Study of Sleep Apnea Participants (SHARP)Presentation Date and Time: Thursday, May 30, 12:30 p.m. – 2:15 p.m.Lead Author: David Gozal, MD, MBA, Marie M. and Harry L. Smith Endowed Chair and the Chairman of the Department of Child Health at the University of Missouri Poster Number: T38Location: Salon 4 About AUVELITY®AUVELITY is a novel, oral, NMDA receptor antagonist with multimodal activity approved for the treatment of MDD in adults. AUVELITY is a proprietary extended-release oral tablet containing dextromethorphan HBr (45 mg) and bupropion HCl (105 mg). The dextromethorphan component of AUVELITY is an antagonist of the NMDA receptor (an ionotropic glutamate receptor) and a sigma-1 receptor agonist. These actions are thought to modulate glutamatergic neurotransmission. The bupropion component of AUVELITY is an aminoketone and CYP2D6 inhibitor which serves to increase and prolong the blood levels of dextromethorphan. The exact mechanism of action of Auvelity in the treatment of depression is unclear. AUVELITY received Breakthrough Therapy designation from the FDA for the treatment of MDD. INDICATION AND IMPORTANT SAFETY INFORMATION WHAT IS AUVELITY (aw-VEHL-ah-tee)? It is a prescription oral medicine used to treat adults with major depressive disorder (MDD). It is not known if Auvelity is safe and effective for use in children. Auvelity is not approved for uses other than the treatment of MDD. The ingredients in Auvelity, bupropion and dextromethorphan, are the same ingredients found in some other medicines approved for other uses. WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT AUVELITY? Auvelity and other antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults, especially within the first few months of treatment or when the dose is changed. Auvelity is not for use in children. You should pay close attention to any new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions. This is very important when starting or changing the dose of an antidepressant medicine. Call your healthcare provider (HCP) or get emergency help right away if you or your loved one have any of the following symptoms, especially if they are new, worse, or worry you: suicidal thoughts or actionsnew or worsening depression or anxietyagitation or restlessnesstrouble sleeping (insomnia)acting aggressive, being angry violentan extreme increase in activity and talking (mania)panic attacksnew or worsening irritabilityacting on dangerous impulsesother unusual changes in behavior or mood Do not take Auvelity if you: have or had a seizure disorder.have or had an eating disorder like anorexia or bulimia.have recently and suddenly stopped drinking alcohol or use medicines called benzodiazepines, barbiturates, or anti-seizure medicines, and you have recently suddenly stopped taking them.are taking a monoamine oxidase inhibitor (MAOI), have stopped taking an MAOI in the last 14 days, or are being treated with the antibiotic linezolid or intravenous methylene blue. Ask your HCP or pharmacist if you are unsure whether you take an MAOI. Do not start taking an MAOI until you have stopped taking Auvelity for at least 14 days.are allergic to dextromethorphan, bupropion, or any other ingredients in Auvelity. Auvelity may cause serious side effects. Ask your HCP how to recognize the serious side effects below and what to do if you think you have one: Seizures. There is a risk of seizures during treatment with Auvelity. The risk is higher if you take higher doses of Auvelity, have certain medical problems, or take Auvelity with certain other medicines. Do not take Auvelity with other medicines unless your healthcare provider tells you to. If you have a seizure during treatment with Auvelity, stop taking Auvelity and call your HCP right away. Do not take Auvelity again if you have a seizure. Increases in blood pressure (hypertension). Some people may get high blood pressure during treatment with Auvelity. Your HCP should check your blood pressure before you start taking and during treatment with Auvelity. Manic episodes. Manic episodes may happen in people with bipolar disorder who take Auvelity. Symptoms may include: greatly increased energyracing thoughtsunusually grand ideastalking more or faster than usualsevere trouble sleepingreckless behaviorexcessive happiness or irritability Unusual thoughts or behaviors. One of the ingredients in Auvelity (bupropion) can cause unusual thoughts or behaviors, including delusions (believing you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your HCP. Eye problems (angle-closure glaucoma). Auvelity may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your HCP if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Dizziness. Auvelity may cause dizziness which may increase your risk for falls. Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take Auvelity with certain other medicines. Call your HCP or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms: agitationhallucinationsconfusioncomafast heartbeatblood pressure changesdizzinesssweatingflushinghigh body temperature (hyperthermia)shaking (tremors), stiff muscles, or muscle twitchingloss of coordinationseizuresnausea, vomiting, diarrhea COMMON SIDE EFFECTS The most common side effects of Auvelity include dizziness, headache, diarrhea, feeling sleepy, dry mouth, sexual function problems, and excessive sweating.These are not all the possible side effects of Auvelity. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch. BEFORE USING Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.It is important to tell your HCP if you are taking: other medicines containing bupropion or dextromethorphanmedicines to treat depression, anxiety, psychotic or thought disorders, including selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressantstheophyllinecorticosteroidsoral diabetes medicines or use insulin to control your blood sugarmedicines to control appetite (anorectic)nicotine medicines to help you stop smokingstreet (illicit) drugsbenzodiazepines, sedative-hypnotic (sleep medicines), or opiates If you are unsure if you take any of these medicines, ask your HCP. They can tell you if it is safe to take Auvelity with your other medicines.Tell your HCP if you are pregnant or plan to become pregnant. Auvelity may harm your unborn baby if you take it during pregnancy. Auvelity is not recommended during pregnancy. Your HCP will prescribe another treatment for females who plan to become pregnant.One of the ingredients in Auvelity passes into your breast milk. Do not breastfeed during treatment with Auvelity and for 5 days after the final dose. Tell your HCP about all your medical conditions, including if you: have problems with your liver or kidneys.have diabetes, heart disease, or high blood pressure.have a history of seizure, stroke, eating disorder, head injury, or have a tumor in your brain or spinal cord.have a history of alcohol or drug abuse.have a history of seizure, eating disorder, or abuse alcohol or drugs.have low blood sugar, low blood sodium levels, or a history of falls.you take certain other medicines that could interact with Auvelity.have or had a condition known as bipolar disorder, a family history of bipolar disorder, suicide, or depression.have high pressure in the eye (glaucoma). Review the list below with your HCP. Auvelity may not be right for you if: you drink a lot of alcohol.you abuse prescription or street drugs.you are pregnant or plan to become pregnant.you are breastfeeding or plan to breastfeed. HOW TO TAKE Auvelity is available by prescription only.Take Auvelity exactly as instructed by your HCP.Take Auvelity 1 time a day for 3 days, then increase your dose to 2 times a day (taken at least 8 hours apart). Do not take more than 2 Auvelity tablets in 24 hours.If you miss a dose, do not take an extra dose. Wait and take your next dose at the regular time. Do not take more than 1 dose of Auvelity at a time.Do not change your dose or stop taking Auvelity without talking to your HCP.Swallow Auvelity tablets whole. Do not crush, chew, or divide the tablets.Do not give Auvelity to other people.If you take too much Auvelity call your HCP or seek medical advice promptly. LEARN MORE For more information about Auvelity, call 866-496-2976 or visit Auvelity.com.This summary provides basic information about Auvelity but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other HCP about Auvelity and how to take it. Your HCP is the best person to help you decide if Auvelity is right for you. AUV CON BS 10/2022 Please see full Prescribing Information, including Boxed Warning for suicidal thoughts and behaviors, and Medication Guide. About Axsome Therapeutics, Inc. Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options. Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians. For more information, please visit the Company’s website at axsome.com. The Company may occasionally disseminate material, nonpublic information on the company website. Forward Looking Statements Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the continued commercial success of our Sunosi® and Auvelity® products and the success of our efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, our product candidates, including statements regarding the timing of any NDA submission; whether issues identified by FDA in the complete response letter may impact the potential approvability of the Company’s NDA for AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to our special protocol assessment for the MOMENTUM clinical trial; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the continued commercialization of Sunosi and Auvelity and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; unforeseen circumstances or other disruptions to normal business operations arising from or related to geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance. Axsome Contacts: Investors:Mark JacobsonChief Operating OfficerAxsome Therapeutics, Inc.One World Trade Center, 22nd FloorNew York, NY 10007Tel: 212-332-3243Email: mjacobson@axsome.com www.axsome.com Media:Darren OplandDirector, Corporate CommunicationsAxsome Therapeutics, Inc.One World Trade Center, 22nd FloorNew York, NY 10007Tel: 929-837-1065Email: dopland@axsome.com www.axsome.com

Drug ApprovalBreakthrough TherapyNDA

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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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.

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 Hydrate

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KEGG	Wiki	ATC	Drug Bank
-	Dextromethorphan Hydrobromide Hydrate	R05DA09	-

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Indication	Country/Location	Organization	Date
Dry cough	CN	Guangzhou Baiyunshan Guang Hua Pharmacy Co., Ltd.	01 Jan 1990
Cough	US	Shionogi Pharma Co., Ltd.	01 Jan 1958

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04392011 (CTgov)	Early Phase 1	-	15	dextromethorphan HBr (Drug Cocktail)	zrunhmbuio(pitebhysqf) = vlqnqtcjct brlgyzcdtq (zbdrbvrcqv, ebjblrjwld - fuuxfjeqbr) View more	-	08 Jun 2023
				Kratom (Kratom + Drug Cocktail)	zrunhmbuio(pitebhysqf) = hiffufoaws brlgyzcdtq (zbdrbvrcqv, euepijnerr - sargayhflx) View more
NCT03883581 (CTgov)	Phase 1/2	Amyotrophic Lateral Sclerosis	28	dextromethorphan HBr+quinidine sulfate	xssjvcpbql(ymzuunrxzy) = sxxttpetcs sooypncbsd (onnijqmmnq, pwxlrzcdlg - wmapsawnej) View more	-	08 Mar 2023
Pubmed	Not Applicable	Cough	112	Dextromethorphan syrup 30 ml (90 mg)	vwtbbqvofr(lucrjayayn) = dzgtittqjk pnjgdvcahs (koztprfdog ) View more	-	10 Jan 2023
				Placebo	vwtbbqvofr(lucrjayayn) = nowwohhyhl pnjgdvcahs (koztprfdog ) View more
NCT03538054 (CTgov)	Phase 2	Fibromyalgia	27	Dextromethorphan (Dextromethorphan)	ytqvxjgfif(rsitkamxhd) = tajuoxkgnr vavzdgwjky (tlmnmfjcni, mzjqzhkdws - pwuozmjtwi) View more	-	26 Aug 2022
				Placebo (Placebo)	ytqvxjgfif(rsitkamxhd) = llnprqxbbv vavzdgwjky (tlmnmfjcni, ovcsouqtjk - hgfzgsgkaf) View more
NCT02651116 (CTgov)	Phase 4	Cough	131	Cough recording device+Dextromethorphan Hydrobromide (Dextromethorphan Hydrobromide)	pkrhflwgnp(ywrsdcltvp) = hgqvkextpc gpwuxvsgqb (esspptzhue, onhvrkfdha - hqgvoupvrr) View more	-	28 Apr 2021
				Cough recording device (Placebo)	pkrhflwgnp(ywrsdcltvp) = crpruyoskp gpwuxvsgqb (esspptzhue, uzrgoymzeg - fhafncjksq) View more
NCT03714919 (CTgov)	Phase 2	Pain \| Hypertrophy of adenoids	10	Dexmedetomidine+Acetaminophen+Dextromethorphan+Ketamine	qsyijmpsvc(ikkyovnstn) = mjrpqvvubg yyoifogtpg (auihtwxfzh, bdibzgkmdo - ulpgfyfado) View more	-	05 Feb 2021
NCT03480009 (CTgov)	Phase 3	Abortion, Habitual \| Pain	156	Dextromethorphan Hydrobromide+Oxycodone (Dextromethorphan, Opted for Narcotic Prescription)	ygevbfyurh(svkhmnsqzx) = lrqryorppo ycgvpscjbo (ygsbsagswx, wsdbiadpos - ncxfxtwnbn) View more	-	06 Aug 2020
				Avicel PH101 (Microcrystalline Cellulose NF) for Compounding+Oxycodone (Placebo, Opted for Narcotic Prescription)	ygevbfyurh(svkhmnsqzx) = ofdjpevqag ycgvpscjbo (ygsbsagswx, leyfyejmyl - xdqsxwnkdx) View more
NCT01441102 (Pubmed \| Transl Vis Sci Technol)	Phase 1/2	Diabetic macular oedema	5	Dextromethorphan 60 mg	miekxluxqq(mnxltkxgxn) = eazqbralim klgyqeixux (hgklgechyp ) View more	-	01 Nov 2018
NCT01361217 (CTgov)	Not Applicable	Medication interactions	10	Lovastatin+Omeprazole+midazolam+caffeine+Fluoxetine+dextromethorphan	urfbmklrkn(eqeoriohcw) = mquzlduayb exuojoplbb (kresyjbjox, gqafpahuaq - tuquemvzsu) View more	-	29 Jun 2018
NCT01435798 (CTgov)	Phase 2	Hyperalgesia \| Neuralgia \| Spinal Cord Injuries	26	Dextromethorphan (0% MTD Dex)	fdsxomeftg(qlwaophttp) = fysfbstcag xtupwclhac (mpyofxgmdr, dopttvmjhb - ucoktckaos) View more	-	04 Apr 2017
				Dextromethorphan (25% MTD Dex)	fdsxomeftg(qlwaophttp) = grnlrfnljb xtupwclhac (mpyofxgmdr, fhylmfjwqw - eoynizaoyz) View more

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