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 Therapeutics, Inc.，生产商为Patheon（part of Thermo Fisher Scientific）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。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)) produced by Patheon (part of Thermo Fisher Scientific) 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, and to evaluate the bioequivalence between the two preparations. 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 Dec 2024

Sponsor / Collaborator

Jiangsu Nhwa Pharmaceutical Co., Ltd.

NCT06736509

/ Enrolling by invitationPhase 3

An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects with Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study

The primary objective of this open-label extension trial is to evaluate the long-term safety of AXS-05 for the treatment of Alzheimer's disease agitation in subjects that participated in ADVANCE-2 and ACCORD-2.

Start Date21 Nov 2024

Sponsor / Collaborator

Axsome Therapeutics, Inc.

CTRI/2024/09/073493

/ Not yet recruitingNot ApplicableIIT

Efficacy of Bupropion-Dextromethorphan fixed dose combination versus Sertraline in major depressive disorder patients: a non-inferiority randomised controlled trial - NIL

Start Date15 Oct 2024

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

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

AIMSMajor 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.METHODSAdult 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.RESULTSThis 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.LIMITATIONSIncomplete data due to reporting; diagnoses captured subject to coding error; and limited generalizability to other populations.CONCLUSIONSUsing 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.

01 Sep 2024·Expert Review of Neurotherapeutics

Profiling the combination of bupropion and dextromethorphan as a treatment option for major depressive disorder

Review

Author: Blanco, Joseph ; Mena, Manuel ; Quimbaya, Pamela ; Dodd, Seetal ; Bustos, Rosa-Helena

INTRODUCTIONMajor Depressive Disorder (MDD) is a common mental health disorder marked by sadness, hopelessness, and anhedonia. Various therapies exist, but their effectiveness is limited. Dextromethorphan hydrobromide combined with bupropion hydrochloride (Auvelity®) is a recently approved alternative for treating this condition in adults.AREAS COVEREDThis review summarizes the neurobiology of major depression and delves into the pharmacology, efficacy, safety, and tolerability of dextromethorphan plus bupropion in adult patients. It is based on observational studies, clinical trials, and other secondary studies obtained through systematic literature searches.EXPERT OPINIONThe combination of bupropion and dextromethorphan as a new pharmacotherapy for mental health is an interesting addition to the treatment options that can be used for MDD. The combination can be used in a range of scenarios, including as a first line therapy, as a second option when a patient has failed to achieve remission with a serotonin targeting agent, and for treatment resistant depression. Further research for other indications, including addiction disorders, may provide exciting results. Although a new combination, clinicians will be very familiar with both agents, increasing their acceptability. This pharmacotherapy also may bring increased impetus for discovering other combinations that may have beneficial synergistic effects.

116

News (Medical) associated with Bupropion Hydrochloride/Dextromethorphan

13 Jan 2025

·axsometherapeuticsinc.gcs-web.com

Axsome Therapeutics Provides Preliminary Fourth Quarter and Full Year 2024 Net Revenue

Auvelity preliminary 4Q and full year 2024 net product sales of $92.6 million and $291.4 million, respectively Sunosi preliminary 4Q and full year 2024 net product revenue of $25.7 million and $93.8 million, respectively NEW YORK, Jan. 13, 2025 (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 net product revenue for the fourth quarter and full year ended December 31, 2024. “We delivered strong revenue growth in 2024 and significantly advanced our industry leading neuroscience pipeline, including achievement of positive Phase 3 results for AXS-05 in Alzheimer’s disease agitation and for AXS-12 in narcolepsy, supporting planned regulatory filings for these indications and products in 2025,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “We also look to carry our commercial momentum into 2025 with continued growth for Auvelity and Sunosi, and are making active launch preparations for AXS-07 for the acute treatment of migraine, if approved.” Preliminary Fourth Quarter and Full Year 2024 Net Product Revenue (Unaudited) Based on preliminary unaudited financial information, Axsome expects total product revenue to be approximately $118.3 million and $385.2 million for the fourth quarter and full year of 2024, respectively. Auvelity® net product sales are expected to be approximately $92.6 million and $291.4 million for the fourth quarter and full year of 2024, respectively. Sunosi® net product revenue is expected to be approximately $25.7 million and $93.8 million for the fourth quarter and full year of 2024, respectively. The foregoing information reflects the Company's estimate with respect to net product revenue for Auvelity and Sunosi 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, Inc. 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 and excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea 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. 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 continued commercial success of the Company’s Sunosi® and Auvelity® 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, including statements regarding the ability of the ACCORD and ADVANCE clinical trials to support the filing of an NDA for Alzheimer’s disease agitation; 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; 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 the Company’s 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; differences between the Company’s 2024 preliminary financial information disclosed herein as compared to the Company’s final 2024 audited financial statements; the fact that estimated net product revenue is not a comprehensive statement of the Company’s financial results and is subject to completion of Company’s financial closing procedures; 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 circumstance. Investors: Mark Jacobson Chief Operating Officer Tel: 212-332-3243 Email: mjacobson@axsome.com Media: Darren Opland Director, Corporate Communications Tel: 929-837-1065 Email: dopland@axsome.com Source: Axsome Therapeutics, Inc.

Financial StatementClinical ResultNDAPhase 3

08 Jan 2025

·pmlive.com

Axsome announces positive results from phase 3 Alzheimer’s disease programme

Axsome Therapeutics has announced that it has successfully completed its late-stage clinical programme evaluating investigational AXS-05 (dextromethorphan-bupropion) in Alzheimer’s disease (AD) agitation. The company said it is planning to submit a new drug application (NDA) to the US Food and Drug Administration (FDA) for the orally-administered candidate in this indication later this year. AD is the most common form of dementia, affecting approximately seven million people in the US. The neurodegenerative disease slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks. Up to 70% of AD patients report agitation, which is characterised by emotional distress as well as verbal and physical aggressiveness, and has been associated with accelerated cognitive decline. In its latest update of AXS-05, Axsome reported that the 295-patient phase 3 ACCORD-2 trial met its primary endpoint, with the drug demonstrating a statistically significantly delay in the time to relapse of agitation, as assessed by the Cohen-Mansfield Agitation Inventory (CMAI) total score, compared to placebo. AXS-05 also achieved ACCORD-2’s key secondary endpoint of relapse prevention, and was shown to reduce worsening for overall AD severity versus placebo. The company noted that the late-stage ADVANCE-2 trial of 408 AD patients did not demonstrate statistical significance for the primary endpoint, change in the CMAI total score from baseline to week five, but said the results for the primary and nearly all secondary endpoints “numerically favoured” AXS-05 over placebo. The candidate was shown to be safe and well tolerated, and was not associated with increased risk of falls, cognitive decline or sedation in either controlled study, or in the long-term safety trial of the drug in patients who were treated for six and 12 months. Axsome’s chief executive officer, Herriot Tabuteau, said: “With the strong results of the ACCORD-2 trial, AXS-05 has now demonstrated substantial and statistically significant improvements in AD agitation across three pivotal, phase 3, placebo-controlled trials [ADVANCE-1, ACCORD-1 and ACCORD-2], underscoring its potential to provide meaningful benefit to patients living with this condition and their families. “The improvements in the AXS-05 arm relative to placebo in ADVANCE-2 did not reach statistical significance. However, we are pleased with the very positive controlled safety data from this trial which will be an essential part of our planned NDA submission of AXS-05 in AD agitation, which is targeted for the second half of 2025.”

Phase 3Clinical ResultNDA

02 Jan 2025

·www.biopharmadive.com

Pfizer exits Sangamo pact; Roche, Ideaya strike ADC deals

Happy New Year! We hope you had a restful holiday; If you took a break from keeping up with biotech news, weve got you covered with a brief rundown of the most important updates from the past week and a half.Pfizer wont move forward with asking regulators to approve a gene therapy for hemophilia A and instead will hand back rights to development partner Sangamo Therapeutics in a blow to the California-based biotechnology company. In a Dec. 30 statement, Sangamo CEO Sandy Macrae said his company was surprised and extremely disappointed by Pfizers decision, which comes some five months after the treatment met its goal in a Phase 3 study of people with the inherited bleeding disorder. Sangamo plans to search for an optimal path forward, which could include partnering with another company. Pfizer has steadily retreated from gene therapy, although it sells a hemophilia B gene therapy called Beqvez that it obtained from Spark Therapeutics. Ned PagliaruloRoche and Ideaya Biosciences acquired rights to similar, experimental lung cancer drugs in separate deals with China-based biotechnology companies. First, Ideaya on Monday paid Hengrui Pharma $75 million upfront for an antibody-drug conjugate that targets the protein delta-like ligand 3, or DLL3, and is currently in preclinical testing. Roche followed on Thursday by paying Innovent Biologics $80 million for a DLL3-targeting ADC that began a Phase 1 trial last month. Both drugs are being evaluated against small-cell lung cancer, a more aggressive and less common form of the disease. Ben FidlerAfter many years of effort, Novartis has obtained positive results from a Phase 3 study for a form of its spinal muscular atrophy gene therapy Zolgensma thats delivered via spinal injection rather than intravenous infusion. Data from the study, called Steer, showed treatment improved motor abilities in people with the neuromuscular disease who were two years of age or older and could still sit but had never walked independently. U.S. regulators suspended testing of the intrathecal formulation in late 2019 over safety concerns, but in August 2021 permitted Novartis to begin the Steer study. Novartis plans to share the new data with health authorities to support approval of the gene therapy in a broader range of people with spinal muscular atrophy. Ned PagliaruloBioNTech will pay the National Institutes of Health $792 million to settle disputes over use of patented technology to develop the mRNA COVID-19 vaccine Comirnaty, marketed by Pfizer, according to a securities filing.The payment will consist of $750 million worth of claimed royalties for the years 2020 through 2023 and $42 million for an amended license agreement that sets new royalty terms. Separately, BioNTech said it has settled with the University of Pennsylvania over patents related to technology used to develop Comirnaty, paying up to $467 million to Penn. Pfizer will reimburse BioNTech $365 million related to the NIH settlement and up to $170 million related to the Penn settlement. Jonathan GardnerAxsome Therapeutics intends to ask regulators for approval of a combination drug its developed to treat agitation caused by Alzheimers disease, despite mixed results from the companys latest late-stage trials. In one Phase 3 study, Axsomes drug, called AXS-05, lowered the risk of relapse in agitation versus placebo. However, AXS-05 missed its goal in another trial. Drawing on positive data from two prior studies, Axsome said it will submit a U.S. approval application in the second half of the year, which analysts expect may still be granted. Ned PagliaruloSanofi and partner SK Bioscience are expanding their partnership as they begin Phase 3 testing of a next-generation pneumococcal conjugate vaccine in children. The shot is designed to protect against 21 serotypes of Streptococcus pneumoniae and, according to Sanofi, is the first of its type targeting more than 20 to enter a Phase 3 trial in infants. The planned trial program will include over 7,700 infants, children and adolescents. If successful, the companies shot could eventually compete with Pfizers Prevnar 20, which in 2023 received a green light from the Food and Drug Administration for use in infants and children. Sanofi and SK Bioscience will co-fund research and development costs, while SK Bioscience will receive a 50 million euros upfront payment from Sanofi. Delilah AlvaradoThe Food and Drug Administration has approved Hikma Pharmaceuticals generic version of Novo Nordisks daily GLP-1 shot for diabetes, Victoza. First approved in 2010, Victoza once was the biggest selling drug in the class. But by 2023 its sales had declined to 8.7 billion kroner, or about $1.3 billion, while revenue from the more potent weekly GLP-1 shot Ozempic has grown since its 2017 launch. Teva Pharmaceutical launched an authorized generic of Victoza in June 2024. Jonathan Gardner '

Phase 3Drug ApprovalVaccineClinical ResultPhase 1

100 Deals associated with Bupropion Hydrochloride/Dextromethorphan

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

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Depressive Disorder, Major	US	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	Phase 3	PR	Axsome Therapeutics, Inc.	17 Jun 2021
Agitation in Dementia	Phase 3	US	Axsome Therapeutics, Inc.	17 Jun 2021
Agitation in Dementia	Phase 3	CA	Axsome Therapeutics, Inc.	17 Jun 2021
Alzheimer Disease	Phase 2	-	Duke University	-
Nicotine Dependence	Discovery	US	Axsome Therapeutics, Inc.	25 Mar 2018
Smoking Cessation	Discovery	US	Axsome Therapeutics, Inc.	25 Mar 2018
Agitation	Discovery	AU	Axsome Therapeutics, Inc.	13 Jul 2017
Dementia due to Alzheimer's disease (disorder)	Discovery	AU	Axsome Therapeutics, Inc.	13 Jul 2017
Psychomotor Agitation	Discovery	AU	Axsome Therapeutics, Inc.	13 Jul 2017
Depressive Disorder, Treatment-Resistant	Discovery	US	Axsome Therapeutics, Inc.	01 Mar 2016

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05557409 (ADVANCE-2, Company_Website) Manual	Phase 3	Alzheimer Disease \| Agitation	408	AXS-05	(nrumhdaqtr) = rdzktuxukv pkgjwfrfyl (soayajstbr ) Not Met View more	Negative	30 Dec 2024
				Placebo	(nrumhdaqtr) = djvleumhst pkgjwfrfyl (soayajstbr ) Not Met View more
NCT04947553 (ACCORD-2, Company_Website) Manual	Phase 3	Alzheimer Disease \| Agitation	167	AXS-05	(fcgqmunaxn): HR = 0.276, P-Value = 0.001 Met View more	Positive	30 Dec 2024
				Placebo
AAN2024	Not Applicable	Agitation in Dementia	-	AXS-05	drfzbnjtjn(wksgxqmbcq) = Overall adverse event rates in the DBP were 28.3% AXS-05, 22.2% placebo hxngmrbfqp (wakdqfiolc ) View more	-	09 Apr 2024
				Placebo
NCT03226522 (ADVANCE, CTgov)	Phase 2/3	Psychomotor Agitation \| Dementia due to Alzheimer's disease (disorder) \| Agitation	366	AXS-05 (AXS-05)	ireaoofhdn(rjcxakndqi) = uicjcmbfuz fdcapfsyve (pjxsqihgey, ijrsepcped - oninvgyexj) View more	-	13 Sep 2023
				Bupropion (Bupropion)	ireaoofhdn(rjcxakndqi) = umyqvzxklp fdcapfsyve (pjxsqihgey, mjfhgdvuug - urdmervpao) View more
EVOLVE (Corporate Publications) Manual	Not Applicable	Depressive Disorder	186	AXS-05	(mntgnhimkx) = dlsbuvrrno lhyjpiynkx (hihofptlfg, 6.33) View more	Positive	07 Dec 2022
NCT04797715 (ACCORD, Corporate Publications) Manual	Phase 3	Alzheimer Disease	178	AXS-05	(kyxrxbnjyu): 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)	glkhysryti(bmahdrgtlk) = qmzmfaqxtf homdsbhxus (aingwmdckj, cajeqkczvf - uarufzimcc) View more	-	12 Oct 2022
				Placebo (Placebo)	glkhysryti(bmahdrgtlk) = mdfgidnrxv homdsbhxus (aingwmdckj, fgjciplnyz - vzkzemkmhp) View more
NCT04039022 (CTgov)	Phase 3	Depressive Disorder, Major \| Depressive Disorder, Treatment-Resistant	876	AXS-05 (dextromethorphan and bupropion) oral tablets	lmrsfwbdxq(ppjtkybiun) = mawvdwpkjd xjruwhoixu (hgvcyovwgx, aanwmekfvs - blvlhtlota) View more	-	12 Oct 2022
NCT03471767 (CTgov)	Phase 2	Smoking Cessation \| Nicotine Dependence	58	AXS-05 (AXS-05)	vycoxslejj(zebukkigjk) = gnvuqlyvom pcqnatzmie (idkseqcbiw, uvvyoixgda - ydtoaimxqj) View more	-	12 Oct 2022
				Bupropion SR (Bupropion SR)	vycoxslejj(zebukkigjk) = kvdoukwvtg pcqnatzmie (idkseqcbiw, luwsxpoiws - pjwznhnutq) View more
NCT04019704 (AXS-05-MDD-301 \| GEMINI, Pubmed)	Phase 3	Depressive Disorder, Major	327	Dextromethorphan-bupropion	(stlhreraea) = jxdcukoptc jcemjpitqk (qwxzqdrljh, 11.7 - 32.7) View more	Positive	30 May 2022
				Placebo	(stlhreraea) = lztilmmdxs jcemjpitqk (qwxzqdrljh ) View more

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