Bupropion Hydrochloride/Naltrexone Hydrochloride

LA JOLLA, Calif.--(BUSINESS WIRE)-- Arialys Therapeutics, a biotechnology company pioneering new precision medicines for autoimmune neuropsychiatry, today announced the appointment of Peter Flynn, Ph.D., as President and Chief Executive Officer. Dr. Flynn has more than 20 years of executive leadership experience in the biotech industry, from private start-ups to established publicly traded companies, scaling companies through key financings and pharma partnerships, advancing novel therapeutics from scientific breakthrough to the clinic, and commercializing FDA-approved medicines. In conjunction, Jay Lichter, Ph.D., Managing Partner of Avalon BioVentures and former President and CEO of Arialys, has been appointed Chair of the company’s Board of Directors. Dr. Lichter said, “Peter’s success in thoughtfully building and funding companies and experience advancing novel therapeutics in the clinic will be invaluable as Arialys brings its lead drug candidate, ART5803, into clinical study for the treatment of ANRE and autoimmune psychosis. As Chair, I look forward to working with Peter and the rest of the team to develop novel precision medicines and diagnostics to help millions of people who suffer from neuropsychiatric disorders driven by autoimmune disease.” “Arialys is on the forefront of transforming the treatment landscape for neuropsychiatry by applying a precision medicine approach to breakthrough insights in autoimmune driven neuropsychiatric diseases,” said Dr. Flynn. “Arialys has already generated significant preclinical proof-of-concept data for ART5803, and I look forward to working with the dedicated team and distinguished Clinical Advisory Board to advance this potentially transformative medicine into the clinic next year. I also am excited to build upon the team’s insights, discovering and characterizing pathogenic autoantibodies, to explore additional therapeutic opportunities for the treatment of CNS diseases driven by autoimmunity.” Prior to joining Arialys, Dr. Flynn was Cofounder and Chief Operating Officer of Artiva Biotherapeutics, where he oversaw business development and strategy, research, manufacturing, and corporate operations. During his time at Artiva, the company achieved significant financing, clearance of several IND applications, the establishment of a built-to-fit office, research labs, and internal GMP manufacturing capability, and corporate partnerships with Merck and Affimed. Prior to Artiva, Dr. Flynn was the Global Head of Development and a senior executive at Orexigen, where he oversaw the post-marketing development and regulatory aspects of Contrave®, an FDA-approved weight-loss prescription medication. Coordinating staff across the U.S., E.U., and MENA regions, he collaborated with the commercial team to ensure effective medical and regulatory support for global partnerships and direct-to-consumer and telemedicine campaigns for Contrave. Prior to Orexigen, Dr. Flynn was Senior Vice President, Early Program Development at Fate Therapeutics, where he was responsible for the development of the iPSC platform and was a member of the senior executive team for Fate’s IPO in 2013. Prior to Fate, he was Vice President of Research at Ren Pharmaceuticals. Dr. Flynn started his industry career at the antibody therapeutics company KaloBios, where as head of biochemistry he helped build both the platform technology and therapeutic pipeline. Dr. Flynn received a Ph.D. in biochemistry from the Imperial Cancer Research Fund / University College London and was a postdoctoral fellow at the University of California, San Francisco. About ANRE and ART5803 Anti-NMDA receptor encephalitis (ANRE), one of the most common forms of autoimmune encephalitis, is a rare, potentially lethal, and poorly managed neurological disease because it is often misdiagnosed. ANRE is caused by autoantibodies that crosslink and drive internalization of NMDA receptors (NMDAR), resulting in psychosis. Arialys’ lead therapeutic ART5803 is a therapeutic antibody designed to treat ANRE by blocking NMDAR autoantibodies. Arialys has generated promising preclinical data in a nonhuman primate disease model confirming ART5803 reverses encephalitis and decreases the behavioral symptoms caused by NMDAR autoantibody pathogenicity in the brain. Arialys has received orphan drug designation from the U.S. FDA for ART5803 for the treatment of ANRE. About Arialys Therapeutics Founded to explore the latest discoveries in autoimmune neuropsychiatry, Arialys Therapeutics is developing new precision medicines to specifically block pathogenic autoantibodies in the brain and meaningfully expand the treatment possibilities for neuropsychiatric disorders driven by autoimmune disease. Arialys is headquartered in the Avalon BioVentures Accelerator on the Torrey Pines Mesa, in La Jolla, California. For more info, visit .

NEW YORK, May 28, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that data from its industry-leading portfolio of novel products for CNS disorders will be presented at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, being held May 28-31, 2024, in Miami Beach, Florida. The presentations include new data from post-hoc analyses of Auvelity® showing improvements in anhedonic symptoms that strongly correlate with improvements in daily function in patients with major depressive disorder (MDD) and data on the clinical profile of AXS-05 in treatment of Alzheimer’s disease agitation. Details for the presentation are as follows: Major Depressive Disorder Title: Effects of AXS-05 (Dextromethorphan-Bupropion) in Improving Anhedonia and Interest-Activity Symptoms of MDD and the Associated Improvements in Functional ImpairmentPresentation Date and Time: Wednesday, May 29, 11:15 a.m. – 1 p.m.Lead Author: Roger McIntyre, MD, Professor of Psychiatry and Pharmacology at the University of TorontoPoster Number: W17Location: Salon 4 Title: Real-World AXS-05 Patient Characteristics in Major Depressive DisorderPresentation Date and Time: Wednesday, May 29, 11:15 a.m. – 1 p.m.Lead Author: Andrew Muzyk, MD, Associate Professor of the Practice of Medical Education at Duke UniversityPoster Number: W40Location: Salon 4 Alzheimer’s Disease Agitation Title: Clinical Profile of AXS-05 (Dextromethorphan-Bupropion) in Treating Alzheimer’s Disease Agitation (ADA): Results From The Phase 2/3 Development ProgramPresentation Date and Time: Wednesday, May 29, 11:15 a.m. – 1 p.m.Lead Author: Jeffrey Cummings, MD, ScD, Vice Chair of Research, UNLV Department of Brain HealthPoster Number: W47Location: Salon 4 Cognition Title: Solriamfetol Improves Cognitive Performance in Preclinical Models of Sleep Apnea and in a Randomized Placebo-controlled Study of Sleep Apnea Participants (SHARP)Presentation Date and Time: Thursday, May 30, 12:30 p.m. – 2:15 p.m.Lead Author: David Gozal, MD, MBA, Marie M. and Harry L. Smith Endowed Chair and the Chairman of the Department of Child Health at the University of Missouri Poster Number: T38Location: Salon 4 About AUVELITY®AUVELITY is a novel, oral, NMDA receptor antagonist with multimodal activity approved for the treatment of MDD in adults. AUVELITY is a proprietary extended-release oral tablet containing dextromethorphan HBr (45 mg) and bupropion HCl (105 mg). The dextromethorphan component of AUVELITY is an antagonist of the NMDA receptor (an ionotropic glutamate receptor) and a sigma-1 receptor agonist. These actions are thought to modulate glutamatergic neurotransmission. The bupropion component of AUVELITY is an aminoketone and CYP2D6 inhibitor which serves to increase and prolong the blood levels of dextromethorphan. The exact mechanism of action of Auvelity in the treatment of depression is unclear. AUVELITY received Breakthrough Therapy designation from the FDA for the treatment of MDD. INDICATION AND IMPORTANT SAFETY INFORMATION WHAT IS AUVELITY (aw-VEHL-ah-tee)? It is a prescription oral medicine used to treat adults with major depressive disorder (MDD). It is not known if Auvelity is safe and effective for use in children. Auvelity is not approved for uses other than the treatment of MDD. The ingredients in Auvelity, bupropion and dextromethorphan, are the same ingredients found in some other medicines approved for other uses. WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT AUVELITY? Auvelity and other antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults, especially within the first few months of treatment or when the dose is changed. Auvelity is not for use in children. You should pay close attention to any new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions. This is very important when starting or changing the dose of an antidepressant medicine. Call your healthcare provider (HCP) or get emergency help right away if you or your loved one have any of the following symptoms, especially if they are new, worse, or worry you: suicidal thoughts or actionsnew or worsening depression or anxietyagitation or restlessnesstrouble sleeping (insomnia)acting aggressive, being angry violentan extreme increase in activity and talking (mania)panic attacksnew or worsening irritabilityacting on dangerous impulsesother unusual changes in behavior or mood Do not take Auvelity if you: have or had a seizure disorder.have or had an eating disorder like anorexia or bulimia.have recently and suddenly stopped drinking alcohol or use medicines called benzodiazepines, barbiturates, or anti-seizure medicines, and you have recently suddenly stopped taking them.are taking a monoamine oxidase inhibitor (MAOI), have stopped taking an MAOI in the last 14 days, or are being treated with the antibiotic linezolid or intravenous methylene blue. Ask your HCP or pharmacist if you are unsure whether you take an MAOI. Do not start taking an MAOI until you have stopped taking Auvelity for at least 14 days.are allergic to dextromethorphan, bupropion, or any other ingredients in Auvelity. Auvelity may cause serious side effects. Ask your HCP how to recognize the serious side effects below and what to do if you think you have one: Seizures. There is a risk of seizures during treatment with Auvelity. The risk is higher if you take higher doses of Auvelity, have certain medical problems, or take Auvelity with certain other medicines. Do not take Auvelity with other medicines unless your healthcare provider tells you to. If you have a seizure during treatment with Auvelity, stop taking Auvelity and call your HCP right away. Do not take Auvelity again if you have a seizure. Increases in blood pressure (hypertension). Some people may get high blood pressure during treatment with Auvelity. Your HCP should check your blood pressure before you start taking and during treatment with Auvelity. Manic episodes. Manic episodes may happen in people with bipolar disorder who take Auvelity. Symptoms may include: greatly increased energyracing thoughtsunusually grand ideastalking more or faster than usualsevere trouble sleepingreckless behaviorexcessive happiness or irritability Unusual thoughts or behaviors. One of the ingredients in Auvelity (bupropion) can cause unusual thoughts or behaviors, including delusions (believing you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your HCP. Eye problems (angle-closure glaucoma). Auvelity may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your HCP if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Dizziness. Auvelity may cause dizziness which may increase your risk for falls. Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take Auvelity with certain other medicines. Call your HCP or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms: agitationhallucinationsconfusioncomafast heartbeatblood pressure changesdizzinesssweatingflushinghigh body temperature (hyperthermia)shaking (tremors), stiff muscles, or muscle twitchingloss of coordinationseizuresnausea, vomiting, diarrhea COMMON SIDE EFFECTS The most common side effects of Auvelity include dizziness, headache, diarrhea, feeling sleepy, dry mouth, sexual function problems, and excessive sweating.These are not all the possible side effects of Auvelity. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch. BEFORE USING Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.It is important to tell your HCP if you are taking: other medicines containing bupropion or dextromethorphanmedicines to treat depression, anxiety, psychotic or thought disorders, including selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressantstheophyllinecorticosteroidsoral diabetes medicines or use insulin to control your blood sugarmedicines to control appetite (anorectic)nicotine medicines to help you stop smokingstreet (illicit) drugsbenzodiazepines, sedative-hypnotic (sleep medicines), or opiates If you are unsure if you take any of these medicines, ask your HCP. They can tell you if it is safe to take Auvelity with your other medicines.Tell your HCP if you are pregnant or plan to become pregnant. Auvelity may harm your unborn baby if you take it during pregnancy. Auvelity is not recommended during pregnancy. Your HCP will prescribe another treatment for females who plan to become pregnant.One of the ingredients in Auvelity passes into your breast milk. Do not breastfeed during treatment with Auvelity and for 5 days after the final dose. Tell your HCP about all your medical conditions, including if you: have problems with your liver or kidneys.have diabetes, heart disease, or high blood pressure.have a history of seizure, stroke, eating disorder, head injury, or have a tumor in your brain or spinal cord.have a history of alcohol or drug abuse.have a history of seizure, eating disorder, or abuse alcohol or drugs.have low blood sugar, low blood sodium levels, or a history of falls.you take certain other medicines that could interact with Auvelity.have or had a condition known as bipolar disorder, a family history of bipolar disorder, suicide, or depression.have high pressure in the eye (glaucoma). Review the list below with your HCP. Auvelity may not be right for you if: you drink a lot of alcohol.you abuse prescription or street drugs.you are pregnant or plan to become pregnant.you are breastfeeding or plan to breastfeed. HOW TO TAKE Auvelity is available by prescription only.Take Auvelity exactly as instructed by your HCP.Take Auvelity 1 time a day for 3 days, then increase your dose to 2 times a day (taken at least 8 hours apart). Do not take more than 2 Auvelity tablets in 24 hours.If you miss a dose, do not take an extra dose. Wait and take your next dose at the regular time. Do not take more than 1 dose of Auvelity at a time.Do not change your dose or stop taking Auvelity without talking to your HCP.Swallow Auvelity tablets whole. Do not crush, chew, or divide the tablets.Do not give Auvelity to other people.If you take too much Auvelity call your HCP or seek medical advice promptly. LEARN MORE For more information about Auvelity, call 866-496-2976 or visit Auvelity.com.This summary provides basic information about Auvelity but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other HCP about Auvelity and how to take it. Your HCP is the best person to help you decide if Auvelity is right for you. AUV CON BS 10/2022 Please see full Prescribing Information, including Boxed Warning for suicidal thoughts and behaviors, and Medication Guide. About Axsome Therapeutics, Inc. Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options. Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians. For more information, please visit the Company’s website at axsome.com. The Company may occasionally disseminate material, nonpublic information on the company website. Forward Looking Statements Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the continued commercial success of our Sunosi® and Auvelity® products and the success of our efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, our product candidates, including statements regarding the timing of any NDA submission; whether issues identified by FDA in the complete response letter may impact the potential approvability of the Company’s NDA for AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to our special protocol assessment for the MOMENTUM clinical trial; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the continued commercialization of Sunosi and Auvelity and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; unforeseen circumstances or other disruptions to normal business operations arising from or related to geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance. Axsome Contacts: Investors:Mark JacobsonChief Operating OfficerAxsome Therapeutics, Inc.One World Trade Center, 22nd FloorNew York, NY 10007Tel: 212-332-3243Email: mjacobson@axsome.com www.axsome.com Media:Darren OplandDirector, Corporate CommunicationsAxsome Therapeutics, Inc.One World Trade Center, 22nd FloorNew York, NY 10007Tel: 929-837-1065Email: dopland@axsome.com www.axsome.com