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Last update 24 Mar 2025

Bupropion Hydrochloride

Last update 24 Mar 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryBupropion Hydrochloride, a molecule of minuscule proportions, is a drug that performs a multi-target function, with receptors and enzymes among its targets, such as the dopamine transporter (DAT), adrenergic receptor, and CYP2D6. Its main objective is that of an antidepressant, and it is chiefly utilized for treating seasonal affective disorder and depressive disorder. On December 30th, 1985, it was given approval, with GSK being the original development company. Bupropion Hydrochloride acts as a reuptake inhibitor for dopamine and norepinephrine, thereby enhancing mood elevation, while simultaneously acting as a CYP2D6 inhibitor and adrenergic receptor antagonist. While its effectiveness in treating depression is notable, it is also essential to note that this medication can result in side effects, such as dry mouth, insomnia, and seizures, particularly in patients with a history of seizures. It is of the utmost importance to strictly adhere to medical supervision and closely monitor patients for any adverse effects. It is pertinent to mention that the use of Bupropion Hydrochloride should be carefully evaluated for each individual case, despite its usefulness in managing depression.

Drug Type

Small molecule drug

Synonyms

Amfebutamone Hydrochloride, Bupropion, Bupropion Hrdrochloride

+ [20]

Target

CYP2D6 x DAT x NET x adrenergic receptor

Action

inhibitors, antagonists

Mechanism

CYP2D6 inhibitors(Cytochrome P450 2D6 inhibitors), Dopamine reuptake inhibitors, NET inhibitors(Norepinephrine transporter inhibitors)

Therapeutic Areas

Nervous System DiseasesOther DiseasesNeoplasms

Active Indication

Seasonal Affective DisorderDepressive Disorder, MajorNicotine Dependence+ [3]

Inactive Indication

Attention Deficit DisorderCrohn DiseaseDiabetes Mellitus, Type 2+ [6]

Originator Organization

GSK Plc

Active Organization

GlaxoSmithKline BV

Research Triangle InstituteBausch Health US LLC

+ [4]

Inactive Organization

GlaxoSmithKline (China) Investment Co., Ltd.Glaxo Wellcome GmbH & Co. KGBiovail Corp.

Drug Highest PhaseApproved

First Approval Date

United States (30 Dec 1985),

Depressive Disorder, Major

RegulationPriority Review (China)

Structure/Sequence

Molecular FormulaC13H19Cl2NO

InChIKeyHEYVINCGKDONRU-UHFFFAOYSA-N

CAS Registry31677-93-7

316

Clinical Trials associated with Bupropion Hydrochloride

NCT06679413

/ Active, not recruitingPhase 1

A Phase 1, Single-Center, Repeat-Dose, Open-Label, Fixed-Sequence Drug-Drug Interaction Study of ZX008 in Healthy Male Or Female Study Participants 18 To 55 Years Of Age

The purpose of the study is to assess the single-dose pharmacokinetics (PK) of 3 probe drugs (midazolam, bupropion, and metformin) before and after repeat doses of ZX008

Start Date04 Dec 2024

Sponsor / Collaborator

UCB Biosciences, Inc.

IRCT20190325043107N48

/ SuspendedPhase 2/3IIT

Investigating the effect and side effects of bupropion on fatigue, disability and quality of life of multiple sclerosis patients

Start Date21 Oct 2024

Sponsor / Collaborator

Tabriz University of Medical Sciences

NCT06609343

/ RecruitingPhase 1/2IIT

Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis (BRISK)

Fatigue is the most common symptom reported by end-stage kidney disease patients on maintenance hemodialysis. Unfortunately, there currently is no medical management for this overwhelming feeling of tiredness. As a result, patients continue to suffer with poor quality of life and impaired daily activities. The purpose of this pilot trial is to find out if bupropion (a medicine commonly prescribed for stopping smoking, seasonal mood disorder, and depression) may help lessen fatigue in hemodialysis patients.
In this study, hemodialysis participants will receive bupropion tablet orally three times a week during routine dialysis procedure for consecutive 8 weeks. Study participants will complete a battery of questionnaires to self-report fatigue, cognition, and quality of life. The study team will collect biological specimens. All these procedures will be performed at the dialysis clinic during routine dialysis procedure.

Start Date18 Oct 2024

Sponsor / Collaborator

University of Texas Health Science Center At San Antonio

100 Clinical Results associated with Bupropion Hydrochloride

100 Translational Medicine associated with Bupropion Hydrochloride

100 Patents (Medical) associated with Bupropion Hydrochloride

993

Literatures (Medical) associated with Bupropion Hydrochloride

01 Mar 2025·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Progress in the study of anti-Alzheimer's disease activity of pyrimidine-containing bioactive molecules

Review

Author: Zhang, Qi ; Zhang, Di ; Zhang, Lin-Lin ; Liu, Yu-Lin ; Chui, Rui-Hao ; Zhang, Qian ; Ma, Li-Ying ; Li, Bing-Qian

Pyrimidines are aromatic, heterocyclic organic compounds characterized by a six-membered ring that contains four carbon atoms and two nitrogen atoms. They have been reported to exhibit a variety of biological activities such as antifungal, antiviral, and anti-Parkinsonian effects. Recently, there has been an increased focus on their potential anti-Alzheimer's properties. Several pyrimidine-based drugs and their analogs are currently undergoing various phases of clinical trials, indicating pyrimidine as a promising chemical structure for drug development. Notably, modifications to the pyrimidine structure significantly influence their activity against Alzheimer's disease. For instance, the introduction of heteroatoms into the pyrimidine ring or alternations in the length of the linkage region have been shown to enhance therapeutic efficacy. This review provides a comprehensive overview of pyrimidine derivatives as potential therapeutics for Alzheimer's disease, with a focus on structure-activity relationship (SAR) studies, design strategies, and binding mechanisms. These insights could pave the way for the development of more effective anti-Alzheimer's medications.

01 Jan 2025·PEDIATRIC ANNALS

Nonstimulant Medications for Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents

Article

Author: Engelhard, Caitlin ; Vilus, Jean Taj

Attention-deficit/hyperactivity disorder (ADHD) is one of the most common pediatric psychiatric disorders and is frequently diagnosed and treated by pediatricians. Stimulant medications are the first-line treatment for ADHD but may not be a good fit for many patients due to side effects, inadequate treatment response, or family preference. Non-stimulant ADHD medications provide a useful alternative for patients that cannot tolerate stimulants, have an incomplete treatment response to stimulants, are at risk for stimulant diversion, or whose family prefers to avoid stimulants. Nonstimulant ADHD medications can be used as monotherapy or added to a stimulant as an augmentation strategy. The recommended nonstimulant ADHD medications include alpha agonists (eg, guanfacine extended-release [ER], clonidine ER) and norepinephrine reuptake inhibitors (eg, atomoxetine, viloxazine). Other nonstimulant medications (eg, buproprion, tricyclic antidepressants, polyunsaturated fatty acids) have been used off-label for ADHD but are not recommended and should only be considered as a third-line option. [ Pediatr Ann . 2025;54(1):e27–e33.]

19 Dec 2024·Cureus Journal of Medical Science

Challenges in the Management of Severe Serotonin Syndrome: A Case Report

Article

Author: Mondegari, Kimia ; Yakhchalian, Pegah ; Daneshvar, Rahi Reza

Serotonin syndrome (SS) is a potentially life-threatening condition that can result from excessive serotonergic activity, often due to SSRIs, formally known as selective serotonin reuptake inhibitors. The syndrome and its effects are often secondary to drug-drug interactions or dose-related. This case highlights a 47-year-old female who presents with a history of major depressive disorder, generalized anxiety disorder, and severe alcohol use disorder. She was brought to the Emergency Department after attempting suicide by ingesting an inordinate amount of bupropion (Wellbutrin). Although bupropion is not a direct serotonergic reuptake inhibitor, its inhibition of the CYP2D6 pathway has the potential to elevate the levels of alternative serotonergic agents, potentially leading to SS. The patient's symptoms were inclusive of autonomic instability and clonus, which are consistent with this syndrome, and which necessitated the discontinuation of all serotonergic medications, in addition to the initiation of supportive care. Management included benzodiazepines, guanfacine, and gabapentin to mitigate the glutamatergic activity SS can induce. This case emphasizes the need to closely monitor those prescribed this class of medications, while concomitantly incorporating interdisciplinary collaborative management for those afflicted with SS.

124

News (Medical) associated with Bupropion Hydrochloride

11 Mar 2025

·www.prnewswire.com

Currax Pharmaceuticals: Peer-Reviewed Study in Obesity Pillars Further Substantiates Cardiovascular Safety Profile of CONTRAVE®/MYSIMBA®

BRENTWOOD, Tenn., March 11, 2025 /PRNewswire/ -- Currax Pharmaceuticals LLC ("Currax"), a specialty pharmaceutical company and manufacturer of the #1 branded oral weight loss medication CONTRAVE® (naltrexone HCl/bupropion HCl), today announced the publication of its Cardiovascular Health Outcomes Analysis (HOA) for CONTRAVE®/MYSIMBA® in Obesity Pillars, the official journal of the Obesity Medicine Association. This peer-reviewed study, based on electronic health record data from more than 24,600 patients followed for over 4.7 years, found no evidence of excess cardiovascular risk and no statistically significant difference in major adverse cardiovascular events (MACE) between CONTRAVE/MYSIMBA and the comparator drug. The study's publication provides important real-world evidence that further substantiates the cardiovascular safety profile of CONTRAVE/MYSIMBA building on findings from prior clinical trials, a systemic literature review, two published FDA Adverse Event Reporting System (FAERS) database studies, and over ten years of post-marketing safety surveillance. These results provide valuable insights to support regulatory and clinical decision-making in the treatment of obesity. "The publication of this analysis in Obesity Pillars underscores the utility of evaluating long-term cardiovascular outcomes in routine clinical practice," said Michael Kyle, M.D., SVP, Chief Medical Officer of Currax Pharmaceuticals. "The findings further substantiate the cardiovascular safety profile of CONTRAVE/MYSIMBA, aligning with previous clinical and observational studies." CONTRAVE, approved in the U.S. and marketed in Europe as MYSIMBA, has been studied extensively in both randomized clinical trials and observational settings. The latest analysis builds upon prior research, including the LIGHT trial, and complements the ongoing INFORMUS trial, a large-scale cardiovascular outcomes study, which now has enrolled more than 3,000 patients and is designed to meet regulatory post-marketing requirements to further characterize long-term cardiovascular safety. "Obesity is a serious chronic disease, and it's critical that healthcare professionals have access to rigorous, data-driven evidence when considering treatment options," said George Hampton, President and CEO of Currax Pharmaceuticals. "Currax continues to invest in clinical trials designed to increase the utility of Contrave for physicians treating obesity." The full study is available in Obesity Pillars: About Currax Pharmaceuticals LLC Currax Pharmaceuticals LLC is a specialty pharmaceutical business focused on tackling the #1 and #2 causes of preventable death in the United States, smoking and obesity. Currax distributes a range of both branded and generic pharmaceutical products, including CONTRAVE® (naltrexone HCl/bupropion HCl), ONZETRA® Xsail® (sumatriptan nasal powder), Silenor® (doxepin), Treximet®, (sumatriptan/naproxen sodium), and the authorized generic of Treximet®. For more information, please visit . WHAT IS CONTRAVE? Along with diet and exercise, CONTRAVE is a prescription weight-loss medicine that may help some adults with a BMI > 30 kg/m2 (obese) or with a BMI of > 27 kg/m2 (overweight) with at least one weight-related medical problem such as high blood pressure, high cholesterol, or type 2 diabetes, lose weight and keep the weight off. It is not known if CONTRAVE changes your risk of heart problems or stroke or of death due to heart problems or stroke. It is not known if CONTRAVE is safe and effective when taken with other prescription, over-the-counter, or herbal weight-loss products. CONTRAVE is not approved to treat depression or other mental illnesses, or to help people quit smoking (smoking cessation). IMPORTANT SAFETY INFORMATION CONTRAVE can cause serious side effects including: Suicidal thoughts or actions: One of the ingredients in CONTRAVE is bupropion. Bupropion has caused some people to have suicidal thoughts or actions or unusual changes in behavior, whether or not they are taking medicines used to treat depression. Bupropion may increase the risk of suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. If you already have depression or other mental illnesses, taking bupropion may cause it to get worse, especially within the first few months of treatment. While taking CONTRAVE, you or your family members should pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when you start taking CONTRAVE or when your dose changes. Stop taking CONTRAVE and call a healthcare provider right away if you or your family members notice any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempts to commit suicide; depression; anxiety; feeling agitated or restless; panic attacks; irritability; aggression, anger, or violence; acting on dangerous impulses; an extreme increase in activity and talking; other unusual changes in behavior or mood; trouble sleeping. CONTRAVE is not approved for use in children under the age of 18. Do not take CONTRAVE if you have uncontrolled high blood pressure; have or have had seizures; use other medicines that contain bupropion such as WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, APLENZIN and ZYBAN; have or have had an eating disorder called anorexia or bulimia; are dependent on opioid pain medicines or use medicines to help stop taking opioids, or are in opiate withdrawal; drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines and stop using them all of a sudden; are taking or have taken medicines called monoamine oxidase inhibitors (MAOIs) in the past 14 days; or are allergic to any of the ingredients in CONTRAVE. Tell your healthcare provider about all of your medical conditions including if you have: depression or other mental illnesses; attempted suicide; seizures; head injury; tumor or infection of brain or spine; low blood sugar or low sodium; liver or kidney problems; high blood pressure; heart attack, heart problems, or stroke; eating disorder; drinking a lot of alcohol; prescription medicine or street drug abuse; are 65 or older; diabetes; pregnant or planning to become pregnant; or breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. CONTRAVE may cause serious side effects, including: Seizures. There is a risk of having a seizure when you take CONTRAVE. The risk of seizure is higher in people who take higher doses of CONTRAVE, have certain medical conditions, or take CONTRAVE with certain other medicines. Do not take any other medicines while you are taking CONTRAVE unless your healthcare provider has said it is okay to take them. If you have a seizure while taking CONTRAVE, stop taking CONTRAVE and call your healthcare provider right away. Risk of opioid overdose. Do not take large amounts of opioids, including opioid-containing medicines, such as heroin or prescription pain pills, to try to overcome the opioid-blocking effects of naltrexone. This can lead to serious injury, coma, or death. Get emergency medical help right away if you take opioids and you: have trouble breathing become very drowsy with slowed breathing have slow, shallow breathing feel faint, very dizzy, confused, or have unusual symptoms Sudden opioid withdrawal. People who take CONTRAVE must not use any type of opioid including street drugs, prescription pain medicines, cough, cold, or diarrhea medicines that contain opioids, or opioid dependence treatments, for at least 7 to 10 days before starting CONTRAVE. Using opioids in the 7 to 10 days before you start taking CONTRAVE may cause you to suddenly have symptoms of opioid withdrawal when you take it. Sudden opioid withdrawal can be severe, and you may need to go to the hospital. Tell your healthcare provider you are taking CONTRAVE before a medical procedure or surgery. Severe allergic reactions. Stop taking CONTRAVE and call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of an allergic reaction: rash, itching, hives, fever, swollen lymph glands, painful sores in your mouth or around your eyes, swelling of your lips or tongue, chest pain, or trouble breathing. Increases in blood pressure or heart rate. Some people may get high blood pressure or have a higher heart rate when taking CONTRAVE. Your healthcare provider should check your blood pressure and heart rate before you start taking, and while you take CONTRAVE. Liver damage or hepatitis. Stop taking CONTRAVE and tell your healthcare provider if you have any of the following symptoms of liver problems: stomach area pain lasting more than a few days, dark urine, yellowing of the whites of your eyes, or tiredness. Your healthcare provider may need to stop treating you with CONTRAVE if you get signs or symptoms of a serious liver problem. Manic episodes. Bupropion can cause some people who were manic or depressed in the past to become manic or depressed again. Visual problems (angle-closure glaucoma). Signs and symptoms may include: eye pain, changes in vision, swelling or redness in or around the eye. Talk with your healthcare provider to find out if you are at risk for angle-closure glaucoma and to get treatment to prevent it if you are at risk. Increased risk of low blood sugar in people with type 2 diabetes mellitus who also take medicines to treat their diabetes (such as insulin or sulfonylureas). You should check your blood sugar before you start taking CONTRAVE and while you take CONTRAVE. The most common side effects of CONTRAVE include nausea, constipation, headache, vomiting, dizziness, trouble sleeping, dry mouth, and diarrhea. These are not all of the possible side effects of CONTRAVE. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please see the Full Prescribing Information, including Medication Guide, for CONTRAVE. Media Contact [email protected] SOURCE Currax Pharmaceuticals LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalClinical Result

03 Mar 2025

·axsometherapeuticsinc.gcs-web.com

Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-05 in Alzheimer’s Disease Agitation Supporting NDA Submission

Download PDF Supplemental New Drug Application (sNDA) submission anticipated in 3Q 2025 NEW YORK, March 03, 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 that it has received formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA) supporting a supplemental NDA (sNDA) submission for AXS-05 in Alzheimer’s disease agitation. AXS-05 (dextromethorphan-bupropion) is a novel, oral, investigational NMDA receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor. The purpose of the meeting was to reach agreement with the FDA on the proposed content and format of the Company’s planned sNDA submission including the clinical and nonclinical requirements. Based on the feedback from the FDA, the Company’s regulatory data package would be sufficient for the submission of an sNDA for AXS-05 for the treatment of Alzheimer’s disease agitation. Axsome anticipates submitting the planned sNDA in the third quarter of 2025. Acceptance of the final sNDA will be subject to the FDA’s review of the complete filing. AXS-05 was granted Breakthrough Therapy designation for the treatment of Alzheimer’s disease agitation in June 2020. “We are pleased with the pre-NDA meeting feedback we received from the FDA, which confirmed the studies and data to be presented in our planned sNDA submission of AXS-05 for the treatment of Alzheimer’s disease agitation,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “Alzheimer’s disease agitation is a serious, distressing, and prevalent condition with limited treatment options. If approved, AXS-05 would represent a new mechanism of action for the treatment of Alzheimer’s disease agitation with the potential to address this high unmet medical need. As an FDA Breakthrough Therapy designated program, the application for AXS-05 will be eligible for Priority Review. We look to complete the sNDA submission in the third quarter of 2025, with the goal of making this important new potential therapy available to patients living with Alzheimer’s disease as quickly as possible.” The comprehensive clinical development program of AXS-05 in Alzheimer’s disease agitation includes four completed pivotal, Phase 3, placebo-controlled efficacy trials, and a completed long-term safety trial. AXS-05 demonstrated statistically significant improvement in Alzheimer’s disease agitation, assessed using the Cohen-Mansfield Agitation Inventory (CMAI), compared to placebo, in three Phase 3 efficacy trials: the ADVANCE-1 parallel-group trial (p=0.010), the ACCORD-1 randomized withdrawal trial (p=0.014), and the ACCORD-2 randomized withdrawal trial (p=0.001). Additional controlled safety and supportive efficacy results are provided by a fourth trial (ADVANCE-2). The long-term safety and tolerability of AXS-05 was also evaluated in more than 300 patients treated for at least 6 months and more than 100 patients treated for at least 12 months. AXS-05 was well tolerated with long-term dosing. There were no deaths in patients receiving AXS-05 and AXS-05 was not associated with increased risk of falls, sedation, or cognitive decline as assessed by the Mini-Mental State Examination (MMSE). About Alzheimer’s Disease Agitation Alzheimer’s disease (AD) is the most common form of dementia, affecting approximately 7 million people in the United States.1 Agitation is reported in up to 70% of patients with AD and is characterized by emotional distress, verbal and physical aggressiveness, disruptive irritability, and disinhibition.1,2 AD agitation has been associated with accelerated cognitive decline, increased caregiver burden, earlier nursing home placement, and increased mortality.3 About AXS-05 AXS-05 (dextromethorphan-bupropion) is a novel, oral, investigational N-methyl-D-aspartate (NMDA) receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor under development for the treatment of Alzheimer’s disease (AD) agitation and smoking cessation. AXS-05 utilizes a proprietary formulation and dose of dextromethorphan and bupropion, and Axsome’s metabolic inhibition technology, to modulate the delivery of the components. The dextromethorphan component of AXS-05 is an uncompetitive NMDA receptor antagonist, also known as a glutamate receptor modulator, and a sigma-1 receptor agonist. The bupropion component of AXS-05 serves to increase the bioavailability of dextromethorphan and is a norepinephrine and dopamine reuptake inhibitor. AXS-05 is covered by a robust patent estate extending out to at least 2043. AXS-05 was granted U.S. FDA Breakthrough Therapy designation for the treatment of Alzheimer’s disease agitation in June 2020. 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 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 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 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 circumstance. Investors: Mark Jacobson Chief Operating Officer (212) 332-3243 mjacobson@axsome.com Media: Darren Opland Director, Corporate Communications (929) 837-1065 dopland@axsome.com References Alzheimer’s Association. 2024 Alzheimer’s Disease Facts and Figures. Tractenburg, R.E. et al. Estimating the prevalence of agitation in community-dwelling persons with Alzheimer’s disease. J Neuropsychiatry Clin Neurosci. 2002 Winter;14(1):11-8. Porsteinsson, A.P. and Antonsdottir, I.M. An update on the advancements in the treatment of agitation in Alzheimer’s disease. Expert Opin Pharmacother. 2017 Apr;18(6):611-620. Source: Axsome Therapeutics, Inc.

Phase 3Clinical ResultBreakthrough TherapyNDAPriority Review

10 Feb 2025

·www.biopharmadive.com

Axsome secures top drug’s future with Teva patent settlement

Dive Brief:Axsome Therapeutics gained more than $1 billion in market value Monday, after the brain drug developer disclosed a patent settlement with Teva Pharmaceuticals that will keep a generic copy of Axsomes top drug at bay in the U.S. until at least 2038.Axsome had sued Teva for patent infringement when the generic drugmaker filed for approval of a knock-off version of Auvelity, a medicine for major depressive disorder that last year earned Axsome some $290 million in net sales.Per the settlement struck by the two companies, Teva will gain a license to sell generic Auvelity on or after March 31, 2039, should Axsome gain regulatory exclusivity for pediatric use of the drug. If Axsome doesnt, Teva can enter the U.S. market with its copy on Sept. 30, 2038.Dive Insight:Auvelity is one of three drugs Axsome sells and by far the companys top product.Auvelity combines a form of dextromethorphan, which is used as a cough suppressant in drugs like Robitussin, and bupropion, an antidepressant compound that on its own was previously marketed as Wellbutrin.The New York-based biotechnology company also markets Sunosi, a treatment to improve wakefulness in people with narcolepsy or obstructive sleep apnea, and Symbravo, a migraine medicine that U.S. regulators approved last month.The patent settlement with Teva will ensure Auvelity remains a contributor to Axsomes business for years to come, and removes the threat of Teva entering the market earlier. The biotech has a large tranche of Auvelity patents that expire in 2034, which would have been the next line of defense if Teva had succeeded in challenging Axsomes later-dated patentsThe settlement also provides for the termination of all litigation between Axsome and Teva over Auvelity patents that was pending in the New Jersey district court. The companies will submit their agreement to the Federal Trade Commission and the Department of Justice for review.We see this as a material win for Axsome, wrote Myles Minter, an analyst at William Blair, in a client note. Graig Suvannavejh, an analyst at Mizuho Securites, took a similar view, calling the settlement a significant positive for the company.Investors seemed to agree, pushing Axsome shares up by 23% through mid-morning Monday. Part of those gains may be expectations the settlement will put Axsome higher on pharmaceutical companies lists of deal targets.Staying generic entry with this settlement favorably positions the company if there is a potential M&A buyer for Axsome, in our view, wrote Minter.Theres some recent precedent for this line of thinking. Intra-Cellular Therapies patent settlement with Sandoz for its drug Caplyta was one item Johnson & Johnson reviewed before finalizing a $14.6 billion buyout of Intra-Cellular, recently filed regulatory documents show. '

Patent Infringement

100 Deals associated with Bupropion Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00817	Bupropion Hydrochloride	N06AX12	DB01156

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Seasonal Affective Disorder	United States	Bausch Health US LLC	12 Jun 2006
Nicotine Dependence	Netherlands	GlaxoSmithKline BV	25 Apr 2000
Depressive Disorder	United States	GSK Plc	04 Oct 1996
Depressive Disorder, Major	United States	GSK Plc	30 Dec 1985

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Major depressive disorder, moderate (MDD)	Phase 3	Japan	GSK Plc	17 Jun 2010
Major depressive disorder, moderate (MDD)	Phase 3	South Korea	GSK Plc	17 Jun 2010
Crohn Disease	Phase 3	United States	GSK Plc	01 May 2005
Sexual Dysfunctions, Psychological	Phase 3	United States	GSK Plc	01 May 2004
Epilepsy	Phase 3	United States	GSK Plc	01 Jun 2003
Lethargy	Phase 3	United States	GSK Plc	01 Jun 2003
Attention Deficit Disorder	Phase 3	United States	GSK Plc	01 Oct 2002
Advanced Malignant Solid Neoplasm	Phase 1	United States	Coordination Pharmaceuticals, Inc.Startup	15 Jun 2021
Diabetes Mellitus, Type 2	Phase 1	United States	GSK Plc	16 Jan 2008
Drug abuse	Phase 1	United States	GSK Plc	01 Sep 2002

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04167306 (CTgov)	Phase 2	Alcoholism	388	Placebo for bupropion+Varenicline Tartrate 1 mg b.i.d (2) Varenicline + Placebo for Bupropion)	bedresgbmd(llqdorftyq) = pozbmwzryv cblxwxwnov (ugwiuzjhgl, 0.057) View more	-	07 Jun 2024
				Bupropion Hydrochloride+Varenicline Tartrate 1 mg b.i.d (1) Varenicline + Bupropion)	bedresgbmd(llqdorftyq) = hxlwoooknz cblxwxwnov (ugwiuzjhgl, 0.041) View more
ISC2024	Not Applicable	Acute Ischemic Stroke	-	SSRI/SNRI	gxypdexsyh(iugzzerjhz): RR = 1.29 (95% CI, 1.11 - 1.5)	-	01 Feb 2024
				Dual Antiplatelet Therapy (DAPT)
ISC2024	Not Applicable	Hemorrhagic stroke	-	Selective Serotonin/Serotonin & Norepinephrine Reuptake Inhibitors (SSRI/SNRI)	wqtkiftbjy(ezwisdmgij): RR = 1.33 (95% CI, 1.22 - 1.45)	Negative	01 Feb 2024
				Serotonergic Antidepressants (No AD)
NCT03362099 (GENTSMOKING, Pubmed \| Tob Induc Dis) Manual	Phase 4	Smoking Cessation CYP2B6 rs2279343 \| CHRNA4 rs1044396	361	Bupropion	dglfveenbn(vflfycqjmj) = xptbjewype rtjljbafvh (dpfoylymrm, 49 - 64) View more	Negative	01 Jan 2024
				Varenicline	dglfveenbn(vflfycqjmj) = yrvnuklead rtjljbafvh (dpfoylymrm, 67 - 80) View more
ANA2023	Not Applicable	-	211	GLP-1 agonists	iwynzyvopt(ssxfvqgvlb) = sremocrxne pqnvrdeluq (mybnalqjqk ) View more	Positive	01 Sep 2023
				Other weight loss medications	iwynzyvopt(ssxfvqgvlb) = wohfovmabr pqnvrdeluq (mybnalqjqk ) View more
NCT03993457 (PRECISE-D, CTgov)	Phase 4	Depressive Disorder	18	Escitalopram (CRP<1, CRP Consistent Antidepressant Selection)	ttogyevkpo = mmxysuuezm hqiywseubw (svfzdoifxp, wdonbkljqk - lrkukvvbkx) View more	-	18 Apr 2023
				Bupropion (CRP> or Equal to 1, CRP Consistent Antidepressant Selection)	ttogyevkpo = kasmqxehtm hqiywseubw (svfzdoifxp, kqzaibqcff - djkcrmiglq) View more
NCT03897439 (CTgov)	Phase 3	Smoking Cessation	392	Nicotine patch (Usual Care (UC))	wzsflomgrk = qmrqfytbjh ixziyzuptf (wisytwgslj, kocscywupt - flhepsrige) View more	-	03 Apr 2023
				Bupropion+Nicotine patch+Varenicline Tartrate (Optimized Care (OPT))	wzsflomgrk = hrillzgjcd ixziyzuptf (wisytwgslj, qjtbbzcyla - jlrtrrfrhf) View more
NAASO2022	Not Applicable	Binge-Eating Disorder	136	Naltrexone+Bupropion	gmnptprthi(wcnkhucnlk) = hlaspkdslg zltwzyrscj (koultscths )	Positive	21 Nov 2022
				Behavioral weight-loss therapy	gmnptprthi(wcnkhucnlk) = ttarjpjild zltwzyrscj (koultscths )
NCT02960763 (OPTIMUM, CTgov)	Phase 4	Depressive Disorder, Major \| Depressive Disorder, Treatment-Resistant	742	Aripiprazole Augmentation (Aripiprazole Augmentation)	mxphrhwdnh(acqanmjaqx) = ngxlzimkcm wilpjhiqpp (uilrlalmtc, xkdetbeqxi - fwwsdsitta) View more	-	24 May 2022
				Bupropion Augmentation (Bupropion Augmentation)	mxphrhwdnh(acqanmjaqx) = jcvjdpcaxe wilpjhiqpp (uilrlalmtc, szvcgjcurp - omtxcuhwlx) View more
NCT03595579 (ASCEND, Literature) Manual	Phase 2	Depressive Disorder, Major	80	AXS-05	fmiplclvbi(mfuwgxfxlz) = juncaglbzh zlxznwgqjc (kdhsppteig ) View more	Superior	18 May 2022
				bupropion	fmiplclvbi(mfuwgxfxlz) = radjogxfiq zlxznwgqjc (kdhsppteig ) View more

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