[Translation] A single-dose, fasting and fed, randomized, open-label, two-period, crossover bioequivalence study of dextromethorphan and bupropion extended-release tablets in healthy volunteers

主要研究目的：以四川科伦药业股份有限公司生产的右美沙芬安非他酮缓释片（45/105 mg）为受试制剂，Axsome公司持证并生产的右美沙芬安非他酮缓释片（45/105 mg，商品名：Auvelity®）为参比制剂，评估受试制剂和参比制剂在空腹或餐后条件下给药后的生物等效性。次要研究目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

The primary study objective was to evaluate the bioequivalence of the test and reference formulations, using Dextromethorphan and Bupropion Extended-Release Tablets (45/105 mg) produced by Sichuan Kelun Pharmaceutical Co., Ltd. as the test formulation and Dextromethorphan and Bupropion Extended-Release Tablets (45/105 mg, trade name: Auvelity®), licensed and manufactured by Axsome, as the reference formulation, following administration under fasting and fed conditions. The secondary study objective was to observe the safety of the test and reference formulations in healthy volunteers.

Start Date28 Aug 2025

Sponsor / Collaborator

Sichuan Kelun Pharmaceutical Co., Ltd.

CTR20253260

/ RecruitingPhase 3

一项评估右美沙芬安非他酮缓释片治疗成人抑郁症患者的有效性和安全性的多中心、随机、双盲、安慰剂对照的Ⅲ期临床研究

[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of dextromethorphan and bupropion extended-release tablets in the treatment of adult patients with depression

主要目的：评价右美沙芬安非他酮缓释片治疗抑郁症的有效性次要目的：评价右美沙芬安非他酮缓释片治疗抑郁症的安全性。

[Translation]

Primary objective: To evaluate the efficacy of dextromethorphan/bupropion extended-release tablets in the treatment of depression. Secondary objective: To evaluate the safety of dextromethorphan/bupropion extended-release tablets in the treatment of depression.

Start Date27 Aug 2025

Sponsor / Collaborator

Jiangsu Nhwa Pharmaceutical Co., Ltd.

NCT06957223

/ Active, not recruitingNot ApplicableIIT

Efficacy of Dextromethorphan-Bupropion Versus SSRIs in the Treatment of Major Depressive Disorder: A Randomized Controlled Trial

The study aims to compare the antidepressant effects of a dextromethorphan-bupropion combination versus standard SSRI therapy in adult patients with major depressive disorder. Participants will be randomized into two groups: one receiving dextromethorphan-bupropion and the other receiving an SSRI (e.g., sertraline or escitalopram). Treatment will last for 6 weeks, with assessments at baseline and study completion. The primary outcome will be the remission rate measured by a validated depression rating scale. Secondary outcomes include change in depressive symptoms severity and safety/tolerability measures.

Start Date06 May 2025

Sponsor / Collaborator-

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

01 Jul 2025·INDIAN JOURNAL OF PHARMACOLOGY

Efficacy and safety of dextromethorphan–bupropion combination (AXS-05) in the treatment of depression: A systematic review and network meta-analysis

Review

Author: Kumar, S. Theepan ; Singh, Astha ; Shahi, Mohit Kumar ; Ashwin, JV

This network meta-analysis evaluated the efficacy and safety of the dextromethorphan–bupropion combination (AXS-05) in treating major depressive disorder (MDD). Data were retrieved from multiple databases, including PubMed, Embase, Scopus, Google Scholar, and ClinicalKey, yielding 60 records. After removing duplicates and excluding irrelevant studies, such as reviews, case reports, posters, and studies focusing on unrelated populations (e.g., Alzheimer’s dementia), two randomized controlled trials (RCTs) – Tabuteau et al. (2022) and Iosifescu et al. (2022) – were selected for final analysis. The inclusion criteria focused on RCTs published between 2014 and 2024, involving adult participants (18–65 years) diagnosed with MDD, and reporting on the efficacy and safety of the dextromethorphan–bupropion combination. Studies that did not focus on MDD, were not in English, or lacked control groups were excluded. The findings indicate superior efficacy of the dextromethorphan–bupropion combination, with remission rates of 46.5% and 39.5%, compared to 16.2% for Bupropion alone and 17.3% for placebo. Despite a higher incidence of mild to moderate adverse events (72.9% vs. 64.6% for Bupropion), the combination’s safety profile remained comparable, with no significant increase in treatment discontinuation. These results suggest that AXS-05 is a promising treatment for MDD, warranting further investigation in larger, diverse populations to confirm its long-term efficacy and safety.

31 Dec 2024·JOURNAL OF MEDICAL ECONOMICS

Real-world treatment patterns of patients with major depressive disorder treated with Auvelity in the United States

Article

Author: Cong, Junjun ; Syed, Fatima Zahara ; Muzyk, Andrew ; Tabuteau, Herriot ; Zhou, Huanxue ; Zhao, Yang

AIMS:

Major depressive disorder (MDD) is a prevalent, chronic disorder. Auvelity (dextromethorphan-bupropion) is a novel, oral N-methyl-D-aspartate (NMDA) receptor antagonist and sigma-1 receptor agonist approved (August 2022) by the FDA for treating MDD in adults. This is the first analysis on real-world Auvelity usage in the United States.

METHODS:

Adult patients initiating Auvelity in the Symphony IDV databases by September 2023 were identified (index date: the first Auvelity claim). Patients had continuous eligibility over the 12-month pre-index period and ≥1 MDD diagnosis (ICD-10-CM codes: F32.*, F33.*) over the 5-year pre-index period. Demographic and clinical characteristics, comorbidities, prior MDD-related medications, and Auvelity initiation status were assessed.

RESULTS:

This analysis included 22,288 patients with MDD treated with Auvelity (mean age 45.1 years; 68.1% women); 40.0% lived in the South and 58.5% had commercial insurance. Comorbidities included mental health disorders (53.5%; 47.6% had anxiety disorders). Overall, 83.7% of the patients had received treatment with selective serotonin reuptake inhibitors (SSRIs; 54.9%), the norepinephrine-dopamine reuptake inhibitor (NDRI [bupropion]; 40.4%), and/or serotonin-norepinephrine reuptake inhibitors (SNRIs; 35.9%) over the 12-month pre-index period. The last MDD-related treatment prior to Auvelity comprised SSRI (22.4%), SNRI (13.2%), and NDRI (12.8%) monotherapies; 294 (1.3%) patients received esketamine. In total, 6,418 (28.8%) patients initiated Auvelity as monotherapy vs 15,870 (71.2%) as an add-on; Auvelity was most frequently added to an SSRI alone (10.7%) or SNRI alone (6.5%). A total of 2,254 (10.1%) patients initiated Auvelity without prior treatment in the 12-month pre-index period.

LIMITATIONS:

Incomplete data due to reporting; diagnoses captured subject to coding error; and limited generalizability to other populations.

CONCLUSIONS:

Using a large demographically distributed claims database, 22,288 patients with MDD initiated Auvelity within a year of its approval; 10.1% were treatment-naïve and 28.8% initiated Auvelity as monotherapy. Most patients had mental health-related comorbidities and attempted various MDD-related treatments prior to Auvelity.

01 Nov 2024·CNS DRUGS

Glutamatergic Modulators for Major Depression from Theory to Clinical Use

Review

Author: McIntyre, Roger S ; Jain, Rakesh

Major depressive disorder (MDD) is a chronic, burdensome, highly prevalent disease that is characterized by depressed mood and anhedonia. MDD is especially burdensome as approved monoamine antidepressant treatments have weeks-long delays before clinical benefit and low remission rates. In the past 2 decades, a promising target emerged to improve patient outcomes in depression treatment: glutamatergic signaling. This narrative review provides a high-level overview of glutamate signaling in synaptogenesis and neural plasticity and the implications of glutamate dysregulation in depression. Based on this preclinical evidence implicating glutamate in depression and the rapid improvement of depression with ketamine treatment in a proof-of-concept trial, a range of N-methyl-D-aspartate (NMDA)-targeted therapies have been investigated. While an array of treatments has been investigated in registered phase 2 or 3 clinical trials, the development of most of these agents has been discontinued. Multiple glutamate-targeted antidepressants are actively in development, and two are approved. Nasal administration of esketamine (Spravato^®) was approved by the US Food and Drug Administration (FDA) in 2019 to treat adults with treatment-resistant depression and in 2020 for adults with MDD with acute suicidal ideation or behavior. Oral combination dextromethorphan-bupropion (AXS-05, Auvelity^® extended-release tablet) was FDA approved in 2022 for the treatment of MDD in adults. These approvals bolster the importance of glutamate in depression and represent an exciting breakthrough in contemporary psychiatry, providing new avenues of treatment for patients as first-line therapy or with either poor response or unacceptable side effects to monoaminergic antidepressants.

182

News (Medical) associated with Bupropion Hydrochloride/Dextromethorphan

15 Jan 2026

·axsometherapeuticsinc.gcs-web.com

Axsome Therapeutics Initiates FORWARD Phase 3 Trial of AXS-14 for the Management of Fibromyalgia

NEW YORK, Jan. 15, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced the first patient has been dosed in the FORWARD Phase 3 trial of AXS-14 (esreboxetine) for the management of fibromyalgia. FORWARD (Fibromyalgia Response with Esreboxetine Evaluated Using a Randomized Withdrawal Research Design) is a Phase 3, double-blind, placebo-controlled, multicenter, randomized withdrawal trial in patients with fibromyalgia consisting of an open-label AXS-14 treatment period and a randomized, double-blind treatment period. Patients achieving a treatment response during the 12-week open-label period will be randomized in a 1:1 ratio to continue AXS-14 (8 mg) once daily or to switch to matching placebo for up to 12 weeks or until a loss of therapeutic response occurs. The primary endpoint will be the time from randomization to loss of therapeutic response. About Fibromyalgia Fibromyalgia is a chronic, debilitating neurological pain disorder that affects approximately 17 million people in the U.S.1,2 Fibromyalgia is considered to be mediated mainly in the central nervous system.2 It is characterized by widespread pain, fatigue, disturbed sleep, depression, cognitive impairment, and hypersensitivity to sensory stimuli.1,2 Other symptoms of this disorder can include tingling in the hands and feet and headaches.2-4 Fibromyalgia has considerable detrimental effects on physical, emotional, social, and day-to-day functioning and is associated with significant economic burden and reduced quality of life.5 Despite its prevalence and impact, current treatment options remain limited. Many patients experience inadequate symptom control or intolerable side effects, with over 50% of fibromyalgia patients discontinuing their treatment within the first year.6 About AXS-14 AXS-14 (esreboxetine) is a highly selective and potent norepinephrine reuptake inhibitor being developed for the management of fibromyalgia. Esreboxetine is the SS-enantiomer of racemic reboxetine. AXS-14 is an investigational drug product not approved by the FDA. About Axsome Therapeutics Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X. Forward Looking Statements Certain matters discussed in this press release are “forward-looking statements”. The Company 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 commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s 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 the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; 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 Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; 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 commercialization of SUNOSI, AUVELITY, and SYMBRAVO 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; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, 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 circumstances. Investors: Ashley Dong Director, Investor Relations (929) 687-1614 adong@axsome.com Media: Darren Opland Senior Director, Corporate Communications (929) 837-1065 dopland@axsome.com References: Source: Axsome Therapeutics, Inc.

Phase 3

12 Jan 2026

·axsometherapeuticsinc.gcs-web.com

Axsome Therapeutics Provides Preliminary Fourth Quarter and Full Year 2025 Net Product Revenue

Total preliminary 4Q and full year 2025 net product revenue of $196.0 million and $638.5 million, respectively, representing 65% and 66% annual growth, respectively AUVELITY® preliminary 4Q and full year 2025 net product sales of $155.1 million and $507.1 million, respectively SUNOSI® preliminary 4Q and full year 2025 net product revenue of $36.7 million and $124.8 million, respectively SYMBRAVO® preliminary 4Q and full year 2025 net product sales of $4.1 million and $6.6 million, respectively NEW YORK, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced preliminary fourth quarter and full year 2025 net product revenues for AUVELITY, SUNOSI, and SYMBRAVO. Preliminary Fourth Quarter and Full Year 2025 Net Product Revenue (Unaudited) Based on preliminary unaudited financial information, Axsome expects total product revenue to be approximately $196.0 million for the fourth quarter, representing 65% annual growth compared to the fourth quarter 2024, and approximately $638.5 million for the full year 2025, representing 66% annual growth compared to the full year 2024. AUVELITY net product sales are expected to be approximately $155.1 million and $507.1 million for the fourth quarter and full year 2025, respectively. SUNOSI net product revenue is expected to be approximately $36.7 million and $124.8 million for the fourth quarter and full year 2025, respectively. SYMBRAVO net product sales are expected to be approximately $4.1 million and $6.6 million for the fourth quarter and full year 2025, respectively, following its commercial launch in June 2025. The foregoing information reflects the Company's estimates with respect to net product revenues for AUVELITY, SUNOSI, and SYMBRAVO based on currently available unaudited information. This announcement is not a comprehensive statement of Axsome’s financial results and is subject to completion of Axsome’s financial closing procedures. Axsome’s final financial results will be issued upon completion of its closing procedures and may vary from these preliminary estimates. About Axsome Therapeutics Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X. Forward Looking Statements Certain matters discussed in this press release are “forward-looking statements”. The Company 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 commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s 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 the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; 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 Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; 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 commercialization of SUNOSI, AUVELITY, and SYMBRAVO 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; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, 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 circumstances. Investors: Ashley Dong Director, Investor Relations (929) 687-1614 adong@axsome.com Media: Darren Opland Senior Director, Corporate Communications (929) 837-1065 dopland@axsome.com Source: Axsome Therapeutics, Inc.

Financial Statement

31 Dec 2025

·firstwordpharma.com

Axsome earns FDA priority review for Alzheimer's agitation drug

Axsome Therapeutics secured FDA priority review for its Alzheimer's disease agitation contender, despite a Phase III programme that served up a mixed bag of clinical results. The news was enough to send company shares up more than 19% on Wednesday.The US regulator accepted Axsome's supplemental application for AXS-05, which combines dextromethorphan and bupropion, and has set a decision deadline of April 30. The same active ingredients are already approved as Auvelity for major depressive disorder (MDD), now annualising more than $500 million in its third full year on the market, according to analysts at Truist Securities."Up to 76% of people with Alzheimer's disease experience agitation, representing a significant unmet medical need for patients and their caregivers, and currently there is a dearth of approved treatments," CEO Herriot Tabuteau said in a company release.Lundbeck and Otsuka Pharmaceutical's Rexulti (brexpiprazole) in 2023 became the first drug approved by the FDA to treat agitation associated with dementia due to Alzheimer's disease.Axsome's Alzheimer's agitation filing will include data from multiple Phase III studies. The company had previously notched successes in the ACCORD-1 and ADVANCE-1 trials, and last December said ACCORD-2 also met its primary endpoint, showing a 3.6-fold lower risk of agitation relapse versus placebo based on Cohen-Mansfield Agitation Inventory (CMAI) total score.But ADVANCE-2, the largest of the four trials with 408 patients, and the one deemed by some analysts to be pivotal for AXS-05's approval, failed to achieve statistical significance on its primary endpoint measuring change in CMAI. The company nevertheless believed it had enough evidence, including longer-term safety data requested by FDA, to support an approval.Truist projects US peak sales near $3 billion by 2038 for the Alzheimer's agitation indication, compared with projected $1.7 billion peak sales for Auvelity in depression. According to the analysts, the agitation opportunity is likely to be significantly larger than MDD, given the relative lack of treatment options and the drug's profile across four Phase III studies.Aside from AXS-05, Axsome also said Wednesday that it plans to submit a filing in January for AXS-12 (reboxetine), which works as both a norepinephrine reuptake inhibitor and cortical dopamine modulator, to treat cataplexy in patients with narcolepsy.

Phase 3Drug ApprovalPriority ReviewClinical Result

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.

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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Agitation in Dementia	NDA/BLA	United States	Axsome Therapeutics, Inc.	31 Dec 2025
Dementia due to Alzheimer's disease (disorder)	Phase 3	Australia	Axsome Therapeutics, Inc.	13 Jul 2017
Psychomotor Agitation	Phase 3	Australia	Axsome Therapeutics, Inc.	13 Jul 2017
Depressive Disorder, Treatment-Resistant	Phase 3	United States	Axsome Therapeutics, Inc.	01 Mar 2016
Nicotine Dependence	Phase 2	United States	Axsome Therapeutics, Inc.	25 Mar 2018
Smoking Cessation	Phase 2	United States	Axsome Therapeutics, Inc.	25 Mar 2018
Alzheimer Disease	Phase 2	-	Duke University	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04947553 (ACCORD-2, Company_Website) Manual	Phase 3	Alzheimer Disease \| Agitation	167	AXS-05	opabzeosjo(ybjlkmlrqm): HR = 0.276, P-Value = 0.001 Met View more	Positive	30 Dec 2024
				Placebo
NCT05557409 (ADVANCE-2, Company_Website) Manual	Phase 3	Alzheimer Disease \| Agitation	408	AXS-05	tqrvbuumzg(uretzplovu) = kykeansbiu ffbtdrhscg (angdptooka ) Not Met View more	Negative	30 Dec 2024
				Placebo	tqrvbuumzg(uretzplovu) = euevednyvq ffbtdrhscg (angdptooka ) Not Met View more
AAN2024	Not Applicable	Agitation in Dementia	-	AXS-05	aevhxujotl(bksucikzva) = Overall adverse event rates in the DBP were 28.3% AXS-05, 22.2% placebo aeijgznsxd (qjhfqxukbc ) View more	-	09 Apr 2024
				Placebo
NCT04797715 (ACCORD, CTAD2023)	Phase 3	Alzheimer Disease	108	AXS-05	nwuslimdfe(duwrpfvzuc) = aksavfpjnv sgynekybav (pcpgggvqed ) View more	Positive	24 Oct 2023
				Placebo	nwuslimdfe(duwrpfvzuc) = omqenasntq sgynekybav (pcpgggvqed ) View more
NCT03226522 (ADVANCE, CTgov)	Phase 2/3	Agitation in Dementia \| Psychomotor Agitation \| Dementia due to Alzheimer's disease (disorder)	366	AXS-05 (AXS-05)	pkuhqyyrbb(lpyrfrnvmx) = sqycpeuhhz sakywvtydr (wbiyedlmov, 1.25) View more	-	13 Sep 2023
				Bupropion (Bupropion)	pkuhqyyrbb(lpyrfrnvmx) = ascjncammb sakywvtydr (wbiyedlmov, 3.02) View more
EVOLVE (Corporate Publications) Manual	Not Applicable	Depressive Disorder	186	AXS-05	uzrzzmdqwm(zlbqzpwtjp) = qiljnckviq brgoedxkfx (jetvqrzzzx, 6.33) View more	Positive	07 Dec 2022
NCT04797715 (ACCORD, Corporate Publications) Manual	Phase 3	Alzheimer Disease	178	AXS-05	trsojqnlai(prcemqlzne): 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	327	AXS-05 (AXS-05)	kokpleaoyk(oiwzhblveo) = osnmsjsfjs qjrhemdxro (enyihnrguu, 0.921) View more	-	12 Oct 2022
				Placebo (Placebo)	kokpleaoyk(oiwzhblveo) = rpphhigplx qjrhemdxro (enyihnrguu, 0.862) View more
NCT03471767 (CTgov)	Phase 2	Smoking Cessation \| Nicotine Dependence	58	AXS-05 (AXS-05)	yymgbzljxm(ktggnwawar) = uxqgmqoahb zdlxzenlux (blpixpsfva, 0.37) View more	-	12 Oct 2022
				Bupropion SR (Bupropion SR)	yymgbzljxm(ktggnwawar) = brpjqyiycl zdlxzenlux (blpixpsfva, 0.39) View more
NCT04039022 (CTgov)	Phase 3	Depressive Disorder, Major \| Depressive Disorder, Treatment-Resistant	876	AXS-05 (dextromethorphan and bupropion) oral tablets	mvrvuaofuk = anusgysypv ooyqptyqwp (ycpkozkqhp, fyjfmsocwc - vuispxlvzv) View more	-	12 Oct 2022

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