主要研究目的：以江苏恩华药业股份有限公司研制生产的右美沙芬安非他酮缓释片（规格：45mg（以C18H25NO·HBr·H2O计）/105mg（以C13H18ClNO·HCl计））为受试制剂，以持证商为Axsome公司，生产商为Patheon公司的右美沙芬安非他酮缓释片（AUVELITY®，规格：45mg（以C18H25NO·HBr·H2O计）/105mg（以C13H18ClNO·HCl计））为参比制剂，研究在中国健康成年受试者单次空腹/餐后口服两制剂的吸收速度和吸收程度，评价两制剂间的生物等效性并为正式试验提供参考。次要研究目的：评估健康受试者单次空腹/餐后口服右美沙芬安非他酮缓释片受试制剂和参比制剂后的安全性。

[Translation]

The main purpose of the study is to use Dextromethorphan Bupropion Sustained-Release Tablets (Specifications: 45 mg (in C18H25NO·HBr·H2O)/105 mg (in C13H18ClNO·HCl)) developed and produced by Jiangsu Enhua Pharmaceutical Co., Ltd. as the test preparation, and Dextromethorphan Bupropion Sustained-Release Tablets (AUVELITY®, Specifications: 45 mg (in C18H25NO·HBr·H2O)/105 mg (in C13H18ClNO·HCl)) developed and produced by Jiangsu Enhua Pharmaceutical Co., Ltd. as the reference preparation, to study the absorption rate and extent of the two preparations after a single fasting/postprandial oral administration in healthy adult subjects in China, evaluate the bioequivalence between the two preparations and provide a reference for formal trials. Secondary purpose of the study: to evaluate the safety of the test preparation and reference preparation of Dextromethorphan Bupropion Sustained-Release Tablets after a single fasting/postprandial oral administration in healthy subjects.

Start Date25 Feb 2024

Sponsor / Collaborator

Jiangsu Nhwa Pharmaceutical Co., Ltd.

NCT06223880 / RecruitingPhase 4

A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms

This is a randomized, double-blind, active-controlled, multi-center study to evaluate the efficacy of AXS-05, compared to bupropion, in preventing the relapse of depressive symptoms in subjects with major depressive disorder (MDD) who have responded to treatment with AXS-05.

Start Date27 Dec 2023

Sponsor / Collaborator

Axsome Therapeutics, Inc.

NCT05976646 / RecruitingPhase 1/2IIT

Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion (AUVELITY) as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder

The overall goal of this project is to collect initial human data on the effects of novel compounds on safety (interactions with an opioid drug, e.g., buprenorphine) and early efficacy signals (subjective effects on negative affect, craving, and opioid withdrawal) in OUD subjects currently in MOUD treatment with buprenorphine.

Start Date18 Sep 2023

Sponsor / Collaborator

Virginia Commonwealth University

[+1]

100 Clinical Results associated with Bupropion Hydrochloride/Dextromethorphan

100 Translational Medicine associated with Bupropion Hydrochloride/Dextromethorphan

100 Patents (Medical) associated with Bupropion Hydrochloride/Dextromethorphan

Literatures (Medical) associated with Bupropion Hydrochloride/Dextromethorphan

30 Nov 2023·Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology

Dextromethorphan-bupropion (Auvelity) for the Treatment of Major Depressive Disorder.

Review

Author: Muzyk, Andrew ; Wilmouth, Charlotte ; Smith, Colin M ; Bunn, Hannah ; Santalucia, Morgan ; McCarthy, Brian

Depression is a significant cause of morbidity and mortality globally. Although various pharmacologic options exist for depression, treatments are limited by delayed or incomplete therapeutic response, low rates of remission, and adverse effects necessitating effective, fast-acting, and better tolerated alternatives. The purpose of this review is to describe the safety and efficacy of dextromethorphan-bupropion (Auvelity), a Food and Drug Administration approved treatment for major depressive disorder in adults. Dextromethorphan modulates glutamate signaling through uncompetitive antagonism of N-methyl-D-aspartate receptors and sigma-1 agonism, while bupropion increases the bioavailability of dextromethorphan by CYP2D6 inhibition. In a phase 3 trial with dextromethorphan-bupropion 45-105 mg for patients with major depressive disorder saw significant reductions in their Montgomery-Åsberg Depression Rating Scale total scores compared to placebo. A phase 2 trial comparing dextromethorphan-bupropion 45-105 mg to bupropion monotherapy led to significant reduction in Montgomery-Åsberg Depression Rating Scale score. Changes in Montgomery-Åsberg Depression Rating Scale with dextromethorphan-bupropion were seen within two weeks in both clinical trials. Remission and response rates were significantly higher with dextromethorphan-bupropion in both studies. The medication was well-tolerated in both trials, with the most common adverse events being rated as mild-to-moderate. Two long-term, open-label studies with dextromethorphan-bupropion saw large reductions in Montgomery-Åsberg Depression Rating Scale scores that were maintained through 12 and 15 months of treatment. In both long-term studies, remission rates approached 70%, while response rates were greater than 80%. These data suggest that dextromethorphan-bupropion is an effective, fast-acting, and well tolerated option for depression treatment and produced remission in a large percentage of patients.

01 Oct 2023·CNS drugs

Dextromethorphan-Bupropion for the Treatment of Depression: A Systematic Review of Efficacy and Safety in Clinical Trials.

Review

Author: Rosenblat, Joshua D ; Ho, Roger ; Rhee, Taeho Greg ; McIntyre, Roger S ; Kwan, Angela T H ; Ceban, Felicia ; Cao, Bing ; Teopiz, Kayla M ; Akbar, Dania ; Subramaniapillai, Mehala

BACKGROUND:

A significant proportion of adults with major depressive disorder (MDD) do not respond to treatments which are currently used in clinical practice such as first-generation monoamine-based antidepressants.

OBJECTIVES:

The objective of this systematic review was to assess the efficacy, safety, and mechanisms of action of AXS-05, a combination of the NMDA-receptor antagonist dextromethorphan with bupropion, in adults with MDD.

METHODS:

We searched PubMed, Embase, Google Scholar, and ClinicalTrials.gov for current studies reporting on efficacy and/or safety of AXS-05 in patients with MDD. The search terms included: "AXS-05" OR "dextromethorphan and bupropion" AND "depression". Studies from database inception to January 2023 were evaluated. Risk of bias was assessed using the Cochrane Risk of Bias tool.

RESULTS:

The search yielded 54 studies of which 5 were included. All studies had low risk of bias. Depression severity, measured with the Montgomery-Åsberg Depression Rating Scale (MADRS) significantly decreased as early as 1-week post-treatment from baseline when compared to a placebo-controlled group (LS mean difference 2.2; 95% CI 0.6-3.9; p = 0.007) and at 2 weeks compared to an active control group (LS mean difference 4.7; 95% CI 0.6-8.8; p = 0.024). Treatment efficacy could be maintained for up to 12 months with mean MADRS score reduction of 23 points from baseline. Clinical remission and response rates also improved at week 1 and were maintained for 12 months. The treatment was well-tolerated, with some transient adverse events reported.

CONCLUSION:

Current evidence suggests that the combination of dextromethorphan and bupropion is a well-tolerated, rapid-acting treatment option for adults with MDD. Initial success with AXS-05 supports the mechanistic role of glutamatergeric and sigma 1 signaling in the pathophysiology of MDD.

01 Apr 2023·The American journal of nursing

New Combination Drug for Depression.

Article

Author: Aschenbrenner, Diane S

Auvelity, an extended-release fixed combination of dextromethorphan and bupropion, is approved for the treatment of major depressive disorder in adults.Like all antidepressants, dextromethorphan-bupropion carries a boxed warning that it may increase the risk of suicidal thoughts and behaviors in pediatric and young adult patients. Seizures can also occur and are more likely at higher doses.The most common adverse effects of dextromethorphan-bupropion include dizziness, nausea, headache, diarrhea, somnolence, dry mouth, sexual dysfunction, hyperhidrosis, anxiety, constipation, decreased appetite, and insomnia.

News (Medical) associated with Bupropion Hydrochloride/Dextromethorphan

04 Jun 2024

·www.globenewswire.com

Axsome Therapeutics Joins the American Migraine Foundation to Highlight Unmet Treatment Needs During Migraine & Headache Awareness Month

NEW YORK, June 04, 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, announced today it is joining the migraine advocacy community to raise awareness of unmet patient needs during Migraine & Headache Awareness Month this June. “Education plays a crucial role in addressing the stigma associated with migraine, a complex neurological disorder often misunderstood as just a headache. By increasing awareness and understanding of migraine's true nature and its potential to cause significant physical, emotional, and economic impact, education can foster empathy and improve societal attitudes towards those affected,” said Nim Signh Vice Chair of American Migraine Foundation (AMF). “The American Migraine Foundation, whose mission is focused on education, support, community, and research, believes those pillars, when working in conjunction with one another, have the most impact on the lives of those impacted by migraine. AMF's programs focus on removing barriers to timely and effective medical treatment, education to support patients to foster effective conversations with their loved ones, employers, and healthcare providers, and research that can hopefully drive the field forward towards precision medicine so that treatments are matched accurately to the individual. Ensuring accessible healthcare is essential for enabling proactive management of migraine and minimizing its extensive impacts on individuals' health and well-being.” More than 37 million Americans suffer from migraine according to the Centers for Disease Control, and it is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation. Migraine is characterized by recurrent attacks of pulsating, often severe and disabling head pain associated with nausea, and sensitivity to light and or sound. It is estimated that migraine accounts for $78 billion in direct (e.g. doctor visits, medications) and indirect (e.g. missed work, lost productivity) costs each year in the United States.1 Published surveys of migraine sufferers indicate that more than 70% are not fully satisfied with their current treatment, that nearly 80% would try a new therapy, and that they desire treatments that work faster, more consistently, and result in less symptom recurrence.2,3 To learn more about migraine advocacy organizations and the resources they provide, please visit the following websites: American Migraine Foundation (https://americanmigrainefoundation.org/). American Migraine Foundation provides free support for millions of Americans living with migraine.Association of Migraine Disorders (https://www.migrainedisorders.org/). Association of Migraine Disorders strives to expand the understanding of migraine by supporting research, education and awareness.CHAMP (https://headachemigraine.org/). The Coalition for Headache and Migraine Patients brings together the patient advocacy organizations to more effectively fight stigma and help people achieve fair access to treatments. Miles for Migraine (https://www.milesformigraine.org/). Miles for Migraine is dedicated to improving the lives of individuals with migraine and headache disease by creating a supportive community for patients and their families.National Headache Foundation (https://headaches.org/). National Headache Foundation increases public awareness regarding headache disorders and the impact it has on the individual, their families, and society. 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 References: Gooch CL, Pracht E, Borenstein AR. The burden of neurological disease in the United States: A summary report and call to action. Ann Neurol. 2017 Apr; 81(4):479-484.Smelt AF, Louter MA, Kies DA, Blom JW, Terwindt GM, van der Heijden GJ, De Gucht V, Ferrari MD, Assendelft WJ. What do patients consider to be the most important outcomes for effectiveness studies on migraine treatment? Results of a Delphi study. PLoS One. 2014 Jun 16;9(6):e98933.Lipton RB, Stewart WF. Acute migraine therapy: do doctors understand what patients with migraine want from therapy? Headache. 1999;39(suppl 2):S20-S26

30 May 2024

·www.globenewswire.com

Axsome Therapeutics to Participate in Upcoming Investor Conferences

NEW YORK, May 30, 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 Axsome will participate in two upcoming investor conferences. The conference details are as follows: William Blair 44th Annual Growth Stock Conference, on Wednesday, June 5, at 2 p.m. Central Time. Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will present a corporate overview at the Loews Chicago Hotel, in Chicago.Goldman Sachs 45th Annual Global Healthcare Conference, on Wednesday, June 12. Axsome leadership will participate in investor meetings at the Loews Miami Beach, in Miami Beach, Florida. A live webcast and archive of the William Blair presentation can be viewed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at www.axsome.com. 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

30 May 2024

·www.biospace.com

Axsome Therapeutics to Participate in Upcoming June 2024 Investor Conferences

NEW YORK, May 30, 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 Axsome will participate in two upcoming investor conferences. The conference details are as follows: William Blair 44th Annual Growth Stock Conference, on Wednesday, June 5, at 2 p.m. Central Time. Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will present a corporate overview at the Loews Chicago Hotel, in Chicago. Goldman Sachs 45th Annual Global Healthcare Conference, on Wednesday, June 12. Axsome leadership will participate in investor meetings at the Loews Miami Beach, in Miami Beach, Florida. A live webcast and archive of the William Blair presentation can be viewed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at . 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 Jacobson Chief Operating Officer Axsome Therapeutics, Inc. One World Trade Center, 22nd Floor New York, NY 10007 Tel: 212-332-3243 Email: mjacobson@axsome.com Media: Darren Opland Director, Corporate Communications Axsome Therapeutics, Inc. One World Trade Center, 22nd Floor New York, NY 10007 Tel: 929-837-1065 Email: dopland@axsome.com

100 Deals associated with Bupropion Hydrochloride/Dextromethorphan

External Link

KEGG	Wiki	ATC	Drug Bank
-	Bupropion Hydrochloride/Dextromethorphan	-	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Depressive Disorder, Major	US	Axsome Therapeutics, Inc.	18 Aug 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Phase 3	PR	Axsome Therapeutics, Inc.	06 Sep 2022
Depression	Phase 3	US	Axsome Therapeutics, Inc.	20 Jun 2019
Agitation	Phase 3	AU	Axsome Therapeutics, Inc.	13 Jul 2017
Dementia due to Alzheimer's disease (disorder)	Phase 3	AU	Axsome Therapeutics, Inc.	13 Jul 2017
Psychomotor Agitation	Phase 3	AU	Axsome Therapeutics, Inc.	13 Jul 2017
Depressive Disorder, Treatment-Resistant	Phase 3	US	Axsome Therapeutics, Inc.	01 Mar 2016
Opioid-Related Disorders	Phase 2	US	Virginia Commonwealth University	04 Aug 2023
Cigarette Smoking	Phase 2	US	Axsome Therapeutics, Inc.	25 Mar 2018
Nicotine Dependence	Phase 2	US	Axsome Therapeutics, Inc.	25 Mar 2018
Smoking Cessation	Phase 2	US	Axsome Therapeutics, Inc.	25 Mar 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03226522 (CTgov)	Phase 2/3	Psychomotor Agitation \| Dementia due to Alzheimer's disease (disorder) \| Agitation	366	AXS-05 (AXS-05)	mwzdubsgdg(bsbnbbtugd) = kbvglcbtvu ojqhomhoyq (csgxdzpekh, gpfnegqjpx - xhyuuykrsw) View more	-	13 Sep 2023
				Bupropion (Bupropion)	mwzdubsgdg(bsbnbbtugd) = vlnmtcgsut ojqhomhoyq (csgxdzpekh, lnbmgcbpin - nsculitthc) View more
EVOLVE (Corporate Publications) Manual	Not Applicable	Depression	186	AXS-05	kmjyxaaddh(uoszvlwxrn) = lsgyjohitm vzhzdvfboo (uphbgjvwao, 6.33) View more	Positive	07 Dec 2022
NCT04797715 (ACCORD, Corporate Publications) Manual	Phase 3	Alzheimer Disease	178	AXS-05	hspfcireva(jwssrckqsp): HR = 0.275, P-Value = 0.014 View more	Positive	28 Nov 2022
				Placebo
NCT04019704 (AXS-05-MDD-301 \| GEMINI, CTgov)	Phase 3	Depressive Disorder, Major \| Depression	327	AXS-05 (AXS-05)	labiebdbii(kgmoseqkvt) = tlkknnhpgz lbqocjkzod (avjqfliodb, vmthqsyoxv - qrwwuhujzs) View more	-	12 Oct 2022
				Placebo (Placebo)	labiebdbii(kgmoseqkvt) = rziyjnyfkm lbqocjkzod (avjqfliodb, kmbmautsbk - ttazdmvser) View more
NCT04039022 (CTgov)	Phase 3	Depressive Disorder, Major \| Depressive Disorder, Treatment-Resistant \| Depression	876	AXS-05 (dextromethorphan+bupropion) oral tablets	vgoxypstzr(wbejdvukou) = khnewheybb bmrpptbabr (pytivvbefz, kjuytwjdws - wdovuyhbdl) View more	-	12 Oct 2022
NCT03471767 (CTgov)	Phase 2	Cigarette Smoking \| Smoking Cessation \| Nicotine Dependence	58	AXS-05 (AXS-05)	xjraaerzhs(ycwgtnhgue) = nqgughzfhp gqaflrvpfl (thuucixpcc, wfzxxovqqe - cwkeezqtkr) View more	-	12 Oct 2022
				Bupropion SR (Bupropion SR)	xjraaerzhs(ycwgtnhgue) = gmmnqduzdm gqaflrvpfl (thuucixpcc, ypjtrctdyo - siiwnqdtgb) View more
NCT04019704 (AXS-05-MDD-301 \| GEMINI, Pubmed)	Phase 3	Depressive Disorder, Major	327	Dextromethorphan-bupropion	iqwcahjbmf(hexpmwgpko) = djihzvaald ujavawiwri (bbougdkiqu, 11.7 - 32.7) View more	Positive	30 May 2022
				Placebo	iqwcahjbmf(hexpmwgpko) = ktlrmmrpku ujavawiwri (bbougdkiqu ) View more
NCT03595579 (ASCEND, Literature) Manual	Phase 2	Depressive Disorder, Major	80	AXS-05	xtticdkqgl(jsmpsbcqaf) = gryusnegyi pdxkpwdtzn (ookjypeytl ) View more	Superior	18 May 2022
				bupropion	xtticdkqgl(jsmpsbcqaf) = evnxbejasp pdxkpwdtzn (ookjypeytl ) View more
NCT03595579 (Pubmed \| Am J Psychiatry)	Phase 2	Depressive Disorder, Major	97	Dextromethorphan-Bupropion (AXS-05)	bjessdnhvj(bgslfnzvcn) = The most common adverse events with dextromethorphan-bupropion were dizziness, nausea, dry mouth, decreased appetite, and anxiety. yzhpcexdzk (uwjskepgsv ) View more	Positive	18 May 2022
				Sustained-release bupropion
NCT03595579 (ASCEND, CTgov)	Phase 2	Depressive Disorder, Major \| Depression	97	AXS-05 (AXS-05)	oathsmmxgg(sxlbfzbmjs) = xvymlykhmf kocxkfdwul (yonctaovqz, hmbkdeclfb - buwqoddliz) View more	-	24 Sep 2021
				Bupropion (Bupropion)	oathsmmxgg(sxlbfzbmjs) = bztmpozwzi kocxkfdwul (yonctaovqz, klnvfgbsgf - qrsovwprtv) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis