Memantine hydrochloride

VANCOUVER, British Columbia & DALLAS--(BUSINESS WIRE)--Alpha Cognition Inc. (Nasdaq: ACOG) (“Alpha Cognition” or the “Company”), a commercial-stage biopharmaceutical company focused on developing therapies for neurodegenerative diseases, today announced it will present new clinical data on ZUNVEYL at the Alzheimer’s Association International Conference (AAIC), taking place July 27–31, 2025, in Toronto, Canada. The Company will share the following poster presentations: Bioequivalence of ZUNVEYL, a Galantamine Prodrug to Galantamine Hydrobromide Extended-Release Demonstrated Under Steady State Conditions (Poster #107147) - July 27 Bioequivalence of ZUNVEYL, a Galantamine Prodrug to Galantamine Hydrobromide Immediate-Release Demonstrated Under Fed and Fasting Conditions (Poster#107030) - July 28 Dose Proportionality of ZUNVEYL, a Galantamine Prodrug, Over a Dosage Range of Five to Fifteen Milligrams Demonstrated Under Fasting Conditions (Poster #107255) -July 30 “We are excited to present data demonstrating ZUNVEYL’s bioequivalence and dose proportionality,” said Dr. Denis Kay, Chief Scientific Officer of Alpha Cognition. “Given the high unmet need and challenges with current treatments, ZUNVEYL has the potential to offer physicians a well-tolerated therapy with compelling clinical benefits.” AAIC is the world’s largest forum for dementia research, convening global leaders in basic and clinical science to advance prevention, diagnosis, and treatment of Alzheimer’s disease. About Alpha Cognition Inc. Alpha Cognition Inc. is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease and cognitive Impairment with mild Traumatic Brain Injury (“mTBI”), for which there are currently no approved treatment options. ALPHA-1062 formulated as a delayed release oral tablet (ZUNVEYL), is an FDA approved new generation acetylcholinesterase inhibitor for the treatment of Alzheimer’s disease, with expected minimal gastrointestinal side effects. ZUNVEYL’s active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer’s dementia, and as a sublingual formulation for cognitive Impairment with mTBI. INDICATION AND USAGE ZUNVEYL is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or to any inactive ingredients in ZUNVEYL. Serious skin reactions have occurred. WARNINGS AND PRECAUTIONS Serious Skin Reactions: Serious skin reactions (Stevens-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving galantamine (the active metabolite of ZUNVEYL tablets). If signs or symptoms suggest a serious skin reaction, use of this drug should not be resumed, and alternative therapy should be considered. Anesthesia: See Drug Interactions Section Cardiovascular Conditions: Cholinesterase inhibitors, including ZUNVEYL, have vagotonic effects on the sinoatrial and atrioventricular nodes, leading to bradycardia and AV block. Bradycardia and all types of heart block have been reported in patients taking cholinesterase inhibitors, both with and without known underlying cardiac conduction abnormalities. Therefore, all patients should be considered at risk for adverse effects on cardiac conduction. Patients treated with galantamine up to 24 mg/day using the recommended dosing schedule showed a dose-related increase in risk of syncope. Gastrointestinal Conditions: Cholinesterase inhibitors, including ZUNVEYL, may increase gastric acid secretion. Patients should be monitored closely for active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical studies of galantamine have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding. Galantamine has been shown to produce nausea, vomiting, diarrhea, anorexia, and weight loss. Monitor the patient's weight during therapy with ZUNVEYL. Genitourinary Conditions: Although this was not observed in clinical trials with galantamine, cholinesterase inhibitors, including ZUNVEYL, may cause bladder outflow obstruction. Neurological Conditions: Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions. Seizure activity may also be a manifestation of Alzheimer's disease. Patients with Alzheimer's disease should be monitored closely for seizures while taking ZUNVEYL. Pulmonary Conditions: Cholinesterase inhibitors, including ZUNVEYL, should be prescribed with care to patients with a history of severe asthma or obstructive pulmonary disease. Monitor for respiratory adverse reactions. ADVERSE REACTIONS The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. DRUG INTERACTIONS Use with Anticholinergics: Galantamine has the potential to interfere with the activity of anticholinergic medications. Use with Cholinomimetics and Other Cholinesterase Inhibitors: A synergistic effect is expected when cholinesterase inhibitors are given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol. USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data may cause fetal harm. Hepatic Impairment: In patients with moderate hepatic impairment, a decrease in clearance of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with severe hepatic impairment is not recommended. Renal Impairment: In patients with a creatinine clearance of 9 to 59 mL/min, an increase in exposure of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with creatinine clearance less than 9 mL/min is not recommended. These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit www.fda.gov/MedWatch or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information. Forward-looking Statements This news release includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company’s current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward‐looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward‐looking statements may include statements regarding the, the long-term benefits of ZUNVEYL, the Company’s timing and planned activities and business strategy to launch ZUNVEYL, the potential timing for the availability of ZUNVEYL, the potential future developments of ZUNVEYL, the market size and demand for ZUNVEYL and the Company’s potential growth opportunities, capital requirements. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward-looking statements are subject to certain risks, including risks regarding our ability to raise sufficient capital to implement our plans to commercialize ZUNVEYL, risks related to our focus on the long-term care market, risks regarding the efficacy and tolerability of ZUNVEYL, risks related to ongoing regulatory oversight on the safety of ZUNVEYL, risk related to market adoption of ZUNVEYL, risks related to the Company’s intellectual property in relation to ZUNVEYL, risks related to the commercial manufacturing, distribution, marketing and sale of ZUNVEYL, risks related to product liability and other risks as described in the Company’s filings with Canadian securities regulatory authorities and available at www.sedar.com and the Company’s filings with the United States Securities and Exchange Commission (the “SEC”), including those risk factors under the heading “Risk Factors” in the Company’s Form S-1/A registration statement as filed with the SEC on January 10, 2025 and available at www.sec.gov. These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future, except as required by law.

继马来酸咪达唑仑片在睡眠障碍细分领域实现精准补位后，宜昌人福药业即将推出旗下另一款精神神经领域重点产品——富马酸二甲酯肠溶胶囊，已于今年1月获得国家药监局批准，近期即将上市。该产品聚焦多发性硬化症（Multiple Sclerosis, MS）这一罕见自身免疫性中枢神经系统疾病，将进一步完善国产药物在该领域的供给体系，推动神经免疫慢病的规范化、口服化、可及化管理路径落地。01多发性硬化症：一种值得被看见的罕见病多发性硬化是一种以中枢神经系统脱髓鞘病变为特征的慢性进展性疾病，常见于青壮年，患者平均发病年龄为20–40岁，女性多于男性。临床表现多样，常包括复视、肢体无力、感觉异常、步态不稳等。根据《中国多发性硬化诊治指南（2023年版）》，我国MS患病率估计为3–5/10万人口，但因认知不足、诊断率低、长期管理缺失，实际就诊人数和规范治疗人群仍远低于国际水平。尤其在一线注射药物依从性差、副作用多、口服治疗选择少的背景下，患者长期治疗保障面临挑战。02富马酸二甲酯：经典机制支持长期管理富马酸二甲酯作为一种口服小分子药物，主要通过激活Nrf2通路，实现抗炎、抗氧化、免疫调节三重作用，可减少炎症因子释放、保护神经轴突，达到延缓疾病进展、降低复发频率的治疗目标。目前，富马酸二甲酯肠溶胶囊已广泛应用于临床孤立综合征（CIS）、复发缓解型（RRMS）及活动性继发进展型（SPMS）等MS患者的长期治疗中（具体报销政策以当地医保部门规定为准），被写入包括美国、欧洲和中国在内的多国诊疗指南，是多国指南、共识推荐的MS缓解期治疗的一线用药。其优势包括：1、作用机制独特：激活Nrf2通路，兼具抗氧化、抗炎作用，既调节免疫又保护神经。2、口服给药方便：肠溶胶囊剂型，口服给药便捷，患者依从性高。3、用药安全性高：副作用轻，严重免疫抑制和感染风险较低，安全性好。4、长期疗效稳定：减少复发，延缓疾病进展，疗效持久，适合长期治疗。5、适用人群广泛：适用于复发型多发性硬化症成人患者，包括CIS、RRMS及活SPMS。6、治疗经济性高：医保乙类药品（具体报销政策以当地医保部门规定为准），日治疗费用低，经济性优越。03宜昌人福加入，丰富国产高质量可及方案此次即将上市的宜昌人福药业富马酸二甲酯肠溶胶囊，已通过仿制药一致性评价，并获得英国MHRA GMP认证，确保制剂质量符合国际标准。在产业链配套方面，宜昌人福依托麻精品种管控经验，生产与供应能力成熟。值得一提的是，早在2022年，宜昌人福药业便已上市氯巴占片，填补了国内罕见病癫痫治疗需求。此次推出富马酸二甲酯肠溶胶囊，标志着企业在罕见病治疗赛道上形成连续发力与专业积累，进一步拓展神经系统用药覆盖广度与深度。04精神神经产品战略延伸，打造多通路治疗生态随着富马酸二甲酯肠溶胶囊的加入，宜昌人福药业在精神神经领域的产品布局进一步延伸，已覆盖包括：抑郁障碍：盐酸安非他酮缓释片、琥珀酸地文拉法辛缓释片癫痫治疗：氯巴占片阿尔茨海默症：盐酸美金刚缓释胶囊睡眠障碍：马来酸咪达唑仑片多发性硬化症：富马酸二甲酯肠溶胶囊从情绪障碍、癫痫防控、阿尔茨海默症、睡眠调节，到中枢神经系统免疫炎症控制，产品布局覆盖多个精神神经关键病程阶段，通过多机制、跨疾病的治疗协同，打造一体化的慢性脑病药物管理解决方案。结语当前，我国MS治疗正处于诊疗标准化推进与患者需求觉醒的交汇阶段。宜昌人福药业的加入，进一步丰富了国产高质量产品体系，助力提升患者长期用药可及性和生活质量，也彰显企业在神经系统罕见病用药赛道的责任与担当。随着更多高质量国产药物的进入，中国神经免疫罕见病治疗的多层次格局正逐步形成。END*声明：此篇文章受众仅为医药、医疗等健康产业专业伙伴，仅供医学药学专业人士使用，不针对普通消费大众。