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-

CTR20242350 / CompletedNot Applicable

右美沙芬安非他酮缓释片人体生物等效性研究预试验方案

[Translation] Preliminary study plan for bioequivalence study of dextromethorphan and bupropion sustained-release tablets in humans

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)) 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, 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 and reference preparations of Dextromethorphan Bupropion Sustained-Release Tablets after a single fasting/postprandial oral administration in healthy subjects.

Start Date30 Jul 2024

Sponsor / Collaborator

Jiangsu Nhwa Pharmaceutical Co., Ltd.

CTR20240490 / TerminatedNot Applicable

右美沙芬安非他酮缓释片人体生物等效性研究预试验

[Translation] Preliminary study on bioequivalence of dextromethorphan and bupropion sustained-release tablets in humans

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.

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: 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.

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 ; Bustos, Rosa-Helena ; Mena, Manuel ; Quimbaya, Pamela ; Dodd, Seetal

INTRODUCTION:

Major 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 COVERED:

This 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 OPINION:

The 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.

105

News (Medical) associated with Bupropion Hydrochloride/Dextromethorphan

29 Oct 2024

·www.globenewswire.com

Axsome Therapeutics Presents Data from Multiple Programs Spanning Its Innovative Neuroscience Portfolio at Psych Congress 2024

NEW YORK, Oct. 29, 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 seven presentations from across its broad portfolio of innovative neuroscience products and product candidates at Psych Congress 2024, being held Oct. 29 - Nov. 2, 2024, in Boston, Massachusetts. Details for the presentations are as follows: Major Depressive Disorder Title: AXS-05 (Auvelity®) in Major Depressive Disorder: Pooled Data from Two Six-Week Controlled Trials (GEMINI and ASCEND)Presentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ETLead Author: Craig Chepke, MD, SUNY Upstate Medical UniversityPoster Number: 171 Title: Effects of AXS-05 (Auvelity®) in Improving Anhedonia and Interest-Activity Symptoms of MDD and the Associated Improvements in Functional Impairment Presentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ETLead Author: Roger McIntyre, MD, Professor of Psychiatry and Pharmacology at the University of TorontoPoster Number: 172 Title: Real-World Treatment Experiences and Expectations by Symptom Severity in Patients with Major Depressive DisorderPresentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ETLead Author: Roger McIntyre, MD, Professor of Psychiatry and Pharmacology at the University of TorontoPoster Number: 198 Alzheimer’s Disease Agitation Title: Clinical Profile of AXS-05 in Treating Alzheimer’s Disease-Related Agitation: Results from The Phase 2/3 Development ProgramPresentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ETLead Author: Jeffrey Cummings, MD, ScD, Vice Chair of Research, UNLV Department of Brain HealthPoster Number: 45 OSA and Narcolepsy Title: Solriamfetol for Excessive Daytime Sleepiness in Patients with Narcolepsy and OSA Reporting Anxiety and Depression in the Real-World SURWEY StudyPresentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ETLead Author: Ulf Kallweit, MD, Assistant Professor of Neurology at the University Witten/Herdecke, GermanyPoster Number: 20 Cognition Title: Effects of Solriamfetol on Cognition in Obstructive Sleep Apnea with Excessive Daytime Sleepiness and Impaired Cognition in the SHARP Clinical TrialPresentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ETLead Author: Yaroslav Winter, MD, Mainz Comprehensive Epilepsy and Sleep Medicine Center, department of neurology, Johannes Gutenberg-University, Mainz, GermanyPoster Number: 92 Title: Effects of Solriamfetol on Cognition in Patients with Excessive Daytime Sleepiness Associated with Narcolepsy in the Real-World SURWEY StudyPresentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ETLead Author: Yaroslav Winter, MD, Mainz Comprehensive Epilepsy and Sleep Medicine Center, department of neurology, Johannes Gutenberg-University, Mainz, GermanyPoster Number: 164 About Axsome Therapeutics 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 www.axsome.com. 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; 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; 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 JacobsonChief Operating Officer(212) 332-3243mjacobson@axsome.com Media:Darren OplandDirector, Corporate Communications(929) 837-1065dopland@axsome.com

29 Oct 2024

·www.pharmaceutical-technology.com

Arrivo targets major depressive disorder in females after early efficacy data

: SP-624 may treat depression in women by modulating the distinct female genetic profile. Credit: Prathankarnpap/Shutterstock Arrivo BioVentures’ SIRT6 activator SP-624 has been found to significantly reduce symptoms of major depressive disorder (MDD), but only in women. Steve Butts, Arrivo CEO, stated that data from a Phase IIa trial (NCT04479852) showed SP-624 elicited a significant reduction in MDD symptoms, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) score. However, reduction was only evident among female patients; for males, no statistically significant difference could be found. Following this trial, the Morrisville, North Carolina-based biotech announced it enrolled its first subject in a Phase I trial (NCT06570369) of the drug for this indication in a 10 October 2024 release. In parallel, Arrivo is running a Phase IIb trial (NCT06254612) specifically focussed on evaluating the drug’s efficacy in female patients as the primary endpoint, which dosed the first patient in April 2024. To explain the disparity, Butts pointed to research indicating gene expression profiles associated with MDD differ between the sexes. A 2018 meta-analysis published in Biological Psychiatry found that of 706 and 882 genes differentially expressed in men and women with MDD, respectively, only 21 genes in common changed in the same direction—were either up- or downregulated for both sexes. “Our drug is the first epigenetic mechanism being tested in depression that can really test that theory”, claims Butts, adding, “this is the first time that a SIRT6 activator has ever been used in a patient with depression.” See Also: Novartis’ Scemblix gains FDA approval for leukaemia GSK to acquire Chimagen’s CMG1A46 for autoimmune disease SP-624 is a small molecule developed by Sirtsei Pharmaceuticals, a subsidiary of Arrivo, which targets Sirtuin 6 (SIRT6). An NAD-dependent enzyme, SIRT6 modulates gene expression, metabolism, and repair associated with MDD, the activation of which is thought to alleviate depression. Beyond mechanistic differences, MDD also presents at different incidence rates between sexes. As per GlobalData analysis , the prevalence of MDD among females was double that of men in across the eight major markets (the US, France, Germany, Italy, Spain, the UK, Japan and Canada) 2023. The MDD market is expected to become $9.6bn in size in 2029 in those same eight markets, as per a GlobalData report. GlobalData is the parent company of Pharmaceutical Technology There are so far no marketed therapies indicated exclusively to treat MDD in women, despite its prevalence and distinct genetic profile, and development in the female-oriented clinical space has met resistance. However, in recent years, drugs like Johnson and & Johnson Innovation Medicines’ (J&J) Spravato (esketamine) and Axsome Therapeutics’ Auvelity (dextromethorphan-bupropion) have been approved to treat MDD. J&J also saw some success in the MDD arena earlier this year when its Phase III study with seltorexant improved depressive symptoms in patients as per the MADRS scale. However, not all have been successful. Sage Therapeutics axed 40% of its staff in September 2023 following the rejection of their drug Zurzuvae (zuranolone) for MDD by the US Food and Drug Administration (FDA). The drug is approved to treat postpartum depression (PPD). Earlier this month (17 October 2024), the company fired 55% of the remaining R&D staff to support the drug’s ongoing launch for PPD.

Phase 2Clinical ResultDrug ApprovalPhase 3Phase 1

24 Sep 2024

·www.globenewswire.com

Axsome Therapeutics Presents Data from Multiple Programs at Sleep Europe 2024

Seven presentations highlight the Company’s growing CNS portfolio and commitment to improving treatment outcomes for patients with sleep disordersNEW YORK, Sept. 24, 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 seven presentations on AXS-12 and solriamfetol at Sleep Europe 2024, the 27th Congress of the European Sleep Research Society, being held September 24-27, 2024, in Seville, Spain. Featured presentations include data from the SYMPHONY Phase 3 trial of AXS-12 in narcolepsy, findings from the CRESCENDO patient survey underscoring the unmet needs of patients with type 1 narcolepsy, and previously reported data on solriamfetol demonstrating improvement in cognitive function in patients with excessive daytime sleepiness (EDS) associated with OSA and narcolepsy. Details for the presentations are as follows: AXS-12: Title: AXS-12 for the Treatment of Narcolepsy: Topline Results from the Phase 3 SYMPHONY TrialPoster Presentation Date and Time: Wednesday, September 25, 12:15 - 1:15 p.m. and 4:00 - 5:45 p.m. CESTLead Author: Michael Thorpy, MD, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine, New York, NY, USAPoster Number: P254 Title: CRESCENDO: Results from a Survey of Symptom Burden and Quality of Life in Patients with Narcolepsy Type 1Poster Presentation Date and Time: Wednesday, September 25, 12:15 - 1:15 p.m. and 4:00 - 5:45 p.m. CESTLead Author: Michael Thorpy, MD, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine, New York, NY, USAPoster Number: P265 Solriamfetol: Title: Solriamfetol and Maintenance of Wakefulness Outcomes in Patients with Narcolepsy and Obstructive Sleep ApneaOral Presentation Date and Time: Tuesday, September 24, 9:55 - 10:01 a.m. CEST Poster Presentation Date and Time: Wednesday, September 25, 12:15 - 1:15 p.m. and 4:00 - 5:45 p.m. CESTLead Author: Michael Thorpy, MD, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine, New York, NY, USAPoster Number: P475 Title: Effects of Solriamfetol on Cognition in Patients with Excessive Daytime Sleepiness Associated with NarcolepsyPoster Presentation Date and Time: Wednesday, September 25, 12:15 - 1:15 p.m. and 4:00 - 5:45 p.m. CESTLead Author: Yaroslav Winter, MD, Mainz Comprehensive Epilepsy and Sleep Medicine Center, Department of Neurology, Johannes Gutenberg-University, Mainz, GermanyPoster Number: P197 Title: Real-world Use of Solriamfetol for Excessive Daytime Sleepiness in Patients Reporting Anxiety or DepressionPoster Presentation Date and Time: Friday, September 27, 10:45 a.m. - 1:30 p.m. CESTLead Author: Yaroslav Winter, MD, Mainz Comprehensive Epilepsy and Sleep Medicine Center, Department of Neurology, Johannes Gutenberg-University, Mainz, Germany Poster Number: P198 Title: SURWEY: Treatment of Excessive Daytime Sleepiness with Solriamfetol: Initiation, Titration, and OutcomePoster Presentation Date and Time: Thursday, September 26, 12:00 - 1:30 p.m. and 5:30 – 6:45 p.m. CESTLead Author: Samantha Floam, DMD, Axsome TherapeuticsPoster Number: P799 Title: Effects of Solriamfetol on Cognition in Obstructive Sleep Apnea with Excessive Daytime Sleepiness and Impaired CognitionPoster Presentation Date and Time: Friday, September 27, 10:45 a.m. - 1:30 p.m. CESTLead Author: Hans Van Dongen, PhD, Professor at Washington State University Poster Number: P1248 About Axsome Therapeutics 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 www.axsome.com. 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; 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; 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 JacobsonChief Operating Officer(212) 332-3243mjacobson@axsome.com Media:Darren OplandDirector, Corporate Communications(929) 837-1065dopland@axsome.com

Phase 3

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	US	Axsome Therapeutics, Inc.	18 Aug 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Phase 3	PR	Axsome Therapeutics, Inc.	06 Sep 2022
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
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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03226522 (ADVANCE, CTgov)	Phase 2/3	Psychomotor Agitation \| Dementia due to Alzheimer's disease (disorder) \| Agitation	366	AXS-05 (AXS-05)	sexrnavbzl(bhubkschqq) = bowexfmsgz rdkkvcquvx (ejvhumydge, ssdeicpxgd - dostbfwbhf) View more	-	13 Sep 2023
				Bupropion (Bupropion)	sexrnavbzl(bhubkschqq) = bkexpiupgx rdkkvcquvx (ejvhumydge, afykqgmvlj - bepfjenmky) View more
EVOLVE (Corporate Publications) Manual	Not Applicable	Depressive Disorder	186	AXS-05	phbyyhbrob(ppphedoyfj) = lyriivbcpc ufozbzgtsn (wxanksxnko, 6.33) View more	Positive	07 Dec 2022
NCT04797715 (ACCORD, Corporate Publications) Manual	Phase 3	Alzheimer Disease	178	AXS-05	vhakhqgnkm(ninyxkkxan): 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)	bjjyunwkuc(lnwdvtzxcp) = fnrmyxbceh ayogiaziel (yzunpugpxr, mdopvvorfd - tcgeqodxwg) View more	-	12 Oct 2022
				Placebo (Placebo)	bjjyunwkuc(lnwdvtzxcp) = sacdfdnhej ayogiaziel (yzunpugpxr, ftdoizliqj - kjamgzxicq) View more
NCT04039022 (CTgov)	Phase 3	Depressive Disorder, Major \| Depressive Disorder, Treatment-Resistant	876	AXS-05 (dextromethorphan and bupropion) oral tablets	hpvumotdoh(kycmzpbkgg) = fbuhxsglnz kwipxcloto (tezqcgaaex, gpanhfvwmi - liftnoekdv) View more	-	12 Oct 2022
NCT03471767 (CTgov)	Phase 2	Cigarette Smoking \| Smoking Cessation \| Nicotine Dependence	58	AXS-05 (AXS-05)	uwmcndmfem(hpiqzezkpg) = pbtcedfxij dgvoxtyird (zzdmgxzxns, txpaxtvjzo - vqlajqvghr) View more	-	12 Oct 2022
				Bupropion SR (Bupropion SR)	uwmcndmfem(hpiqzezkpg) = bntgnvzufi dgvoxtyird (zzdmgxzxns, ykmtrlbfnk - lxnasrlhdx) View more
NCT04019704 (AXS-05-MDD-301 \| GEMINI, Pubmed)	Phase 3	Depressive Disorder, Major	327	Dextromethorphan-bupropion	lckboemaju(oswlabaper) = hmubgwuqkk mswrlpjllz (xivxfrgzra, 11.7 - 32.7) View more	Positive	30 May 2022
				Placebo	lckboemaju(oswlabaper) = adyddapbqy mswrlpjllz (xivxfrgzra ) View more
NCT03595579 (ASCEND, Literature) Manual	Phase 2	Depressive Disorder, Major	80	AXS-05	weqhduweld(mseatpfrrt) = fheahbvaba xvpxsscpge (hlrtqelghk ) View more	Superior	18 May 2022
				bupropion	weqhduweld(mseatpfrrt) = onzjfytkpa xvpxsscpge (hlrtqelghk ) View more
NCT03595579 (Pubmed \| Am J Psychiatry)	Phase 2	Depressive Disorder, Major	97	Dextromethorphan-Bupropion (AXS-05)	vzlfuigxzw(wkqhautmtc) = The most common adverse events with dextromethorphan-bupropion were dizziness, nausea, dry mouth, decreased appetite, and anxiety. veuqiszeuk (mwzrwystgg ) View more	Positive	18 May 2022
				Sustained-release bupropion
NCT03595579 (ASCEND, CTgov)	Phase 2	Depressive Disorder, Major	97	AXS-05 (AXS-05)	uueyoagusr(leqrzdmrys) = kmgjcwugrr tebrdrdvbz (stslrocxra, ppkpufxpyf - trnzulmtuc) View more	-	24 Sep 2021
				Bupropion (Bupropion)	uueyoagusr(leqrzdmrys) = cajehkgcyg tebrdrdvbz (stslrocxra, adrpmyacdk - qawfuikhpu) View more

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