Lidocaine

PRINCETON, N.J., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced it will host a virtual key opinion leader (KOL) event on Wednesday, November 20, 2024 at 2:00 PM ET. To register, click here. The event will feature Abhishek Ray, MD (University Hospitals) and Andrew Webb, PharmD, BCCCP (Massachusetts General Hospital), who will discuss the high unmet medical need and current treatment landscape for patients suffering from aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency. A live question and answer session will follow the formal presentations. About Abhishek Ray, MD Abhishek Ray, MD, is a fellowship-trained, board-certified neurological surgeon at University Hospitals and Associate Professor of neurological surgery at Case Western Reserve University School of Medicine. He specializes in caring for people with cerebrovascular disease (brain aneurysms, stroke, AVMs), pituitary tumors and meningiomas, and in minimally invasive techniques to treat degenerative spine disease. In neurological surgery, there are often multiple ways to treat a single problem, and Dr. Ray is committed to providing each patient with an individualized care plan to optimize results. In 2021, 2022, 2023, and 2024, he was selected by his peers to be included in Cleveland Magazine’s list of Top Doctors. After completing his undergraduate degree in biological systems engineering at the University of California – Davis, Dr. Ray went back to his hometown to attend medical school at the University of Kansas School of Medicine in Kansas City, Kansas, where he was elected to be an ambassador of the school and was inducted into the Alpha Omega Alpha Honor Medical Society. He then went on to complete neurological surgery residency at University Hospitals/Case Western Reserve University School of Medicine, where he also completed fellowship training in neuro-interventional surgery. Dr. Ray stayed on as faculty at UH/Case Western Reserve University School of Medicine to advance neurosurgical education there. He created a unique and comprehensive neurological surgery elective for second-year medical students, of which he is now the course director. He has been an instructor at national skull base courses for neurosurgical residents and fellows and has served as editor of the neuro-interventional section of CNS Nexus, an online library of neurosurgical cases to better prepare trainees for the operating room. About Andrew Webb, PharmD, BCCCP Andrew Webb, PharmD, BCCCP, is a board-certified neurocritical care clinical pharmacy specialist at Massachusetts General Hospital (MGH) and serves as adjunct clinical faculty at Northeastern University School of Pharmacy and Pharmaceutical Sciences. His clinical and research interests include subarachnoid hemorrhage, status epilepticus, traumatic brain injury, and optimizing the medical management of neurocritically ill patients and his clinical practice is on the multidisciplinary neurocritical care team at MGH’s 22-bed neurosciences intensive care unit. Dr. Webb is originally from Rhode Island and completed his undergraduate studies and Doctor of Pharmacy at the University of Rhode Island. He then completed his pharmacy practice residency at Mayo Clinic in Rochester, MN followed by residency in critical care at Oregon Health & Science University in Portland, OR. Dr. Webb serves on the MGH Comprehensive Stroke Center Quality Taskforce and the MGH Neurology Quality Assurance and Committee on Patient Safety, focusing on improving the quality, safety, and effectiveness of medication therapy in stroke, subarachnoid hemorrhage, and other neurologic conditions. He is active in the Neurocritical Care Society, American College of Clinical Pharmacy, and Society for Critical Care Medicine and serves on several committees within these organizations related to critical care and neurology practice, research, and education. He has lectured regionally and nationally on the pharmacotherapy of subarachnoid hemorrhage, status epilepticus, and the unique challenges of pharmacotherapy in neurocritical care. About aneurysmal Subarachnoid Hemorrhage (aSAH) aSAH is bleeding over the surface of the brain in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain. A primary cause of such bleeding is the rupture of an aneurysm. Approximately 70% of aSAH patients experience death or dependence, and more than 30% die within one month of hemorrhage. Approximately 50,000 patients in the United States are affected by aSAH per year, based on market research. Outside of the United States, annual cases of aSAH are estimated at approximately 60,000 in the European Union, and approximately 150,000 in China. About the Grace Therapeutics Asset Portfolio GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for intravenous (IV) infusion in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. GTx-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTx-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTx-104 has the potential to better manage hypotension in aSAH patients. GTx-104 has been administered in over 150 healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine. The addressable market in the United States for GTx-104 is estimated to be about $300 million, based on market research. GTx-102 is a novel, concentrated oral-mucosal spray of betamethasone intended to improve neurological symptoms of Ataxia-Telangiectasia (A-T), for which there are currently no FDA-approved therapies. GTX-102 is a stable, concentrated oral spray formulation comprised of the gluco-corticosteroid betamethasone that, together with other excipients can be sprayed conveniently over the tongue of the A-T patient and is rapidly absorbed. The further development of GTx-102 has been deprioritized in favor of our focus on development of GTx-104. It is also possible that we may license or sell our GTx-102 drug candidate. GTx-101 is a non-narcotic, topical bio-adhesive film-forming bupivacaine spray designed to ease the symptoms of patients suffering with postherpetic neuralgia (PHN). GTx-101 is administered via a metered-dose of bupivacaine spray and forms a thin bio-adhesive topical film on the surface of the patient’s skin, which enables a touch-free, non-greasy application. It also comes in convenient, portable 30 ml plastic bottles. Unlike oral gabapentin and lidocaine patches, we believe that the biphasic delivery mechanism of GTx-101 has the potential for rapid onset of action and continuous pain relief for up to eight hours. No skin sensitivity was reported in a Phase 1 trial. The further development of GTx-101 has been deprioritized in favor of our focus on development of GTx-104. It is also possible that we may license or sell our GTx-101 drug candidate. About Grace Therapeutics Grace Therapeutics is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Grace Therapeutics’s novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. Grace Therapeutics’s lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection with over 40 granted and pending patents. Grace Therapeutics’s lead clinical asset, GTx-104, is an intravenous infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull. For more information, please visit: www.gracetx.com. Forward-Looking Statements Statements in this press release that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and "forward-looking information" within the meaning of Canadian securities laws (collectively, "forward-looking statements"). Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Grace Therapeutics to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements containing the terms "believes," "belief," "expects," "intends," "anticipates," "estimates", "potential," "should," "may," "will," "plans," "continue", "targeted" or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The forward-looking statements in this press release, including statements regarding the timing of a data readout from the Company’s Phase 3 STRIVE-ON safety trial of GTx-104, the timing of the Company’s planned NDA submission with the FDA in connection with the Company's Phase 3 STRIVE-ON safety trial, GTx-104’s commercial prospects; the size of the addressable market for GTx-104, the Company’s beliefs regarding the potential benefits of GTx-104, including GTx-104's potential to bring enhanced treatment options to patients suffering from aSAH, and the anticipated benefits and future development, license or sale of the Company's other drug candidates are based upon Grace Therapeutics's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions of the Phase 3 STRIVE-ON safety trial for GTx-104; (ii) regulatory requirements or developments and the outcome and timing of the proposed NDA application for GTx-104; (iii) changes to clinical trial designs and regulatory pathways; (iv) legislative, regulatory, political and economic developments; and (v) actual costs associated with Grace Therapeutics's clinical trials as compared to management's current expectations. The foregoing list of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in documents that have been and are filed by Grace Therapeutics from time to time with the Securities and Exchange Commission and Canadian securities regulators. All forward-looking statements contained in this press release speak only as of the date on which they were made. Grace Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by applicable securities laws. For more information, please contact: Grace Therapeutics Contact: Prashant KohliChief Executive OfficerTel: 609-322-1602Email: info@gracetx.com www.gracetx.com Investor Relations: LifeSci AdvisorsMike MoyerManaging DirectorPhone: 617-308-4306Email: mmoyer@lifesciadvisors.com

成都 2024年10月30日 /美通社/ -- 全球医美生物制药 领域的领导企业艾尔建美学宣布旗下含利多卡因注射用交联透明质酸钠凝胶乔雅登 ® 朔颜 ® （Juvéderm ® VOLUX ® ）正式在中国上市。 今日， 乔雅登 ® 朔颜 ® 上市会以"解码轮廓，侧颜立现"为主题，诚邀国际及中国医疗美学专家及行业权威人士，共话下面部美学认知与治疗方案及面部年轻化领域的革新思路。 作为一款专为下面部轮廓精雕而设计的透明质酸产品，乔雅登 ® 朔颜 ® 用于面部骨膜上注射，以改善中度下颌后缩患者的下颌轮廓。临床研究表明，乔雅登 ® 朔颜 ® 能维持长达18-24个月 [1],[2] 清晰利落的下颌线条。同时，乔雅登 ® 朔颜 ® 含利多卡因，可以减少治疗过程中患者的疼痛，提升治疗舒适度。 艾尔建美学中国总经理丘汉华 表示："乔雅登 ® 朔颜 ® 获批及上市再次印证了艾尔建美学在产品布局上的深度与前瞻性。自2015年登陆中国市场以来，乔雅登 ® 家族不仅通过技术迭代不断激发新的求美需求，同时通过持续引入全球前沿创新产品，针对医美需求者最为关注的面部细分部位，打造高品质的医生培训体系和专业诊疗方案。作为医美行业始终的革新者，我们将继续以‘敬畏医疗本质，恪守循证原则'的态度矢志创新，为中国医美行业发展注入新的动力。" 研究表明，下颌骨是面部美学的重要组成部分，对整体面貌起到协调美观的重要作用。下面部的形态最富有变化，最能体现个性，同时是定义男性与女性面部特征的关键。随着衰老进程，下颌骨吸收变化导致下面部失去结构支撑，出现衰老迹象。 [3],[4],[5],[6] 因此，下面部对于抗衰以及面部美学风格的塑造具有重要意义。 此次， 全球顶级整形美容专家、面部注射领域开拓者 Dr. Mauricio de Maio 特地莅临上市会现场，解读乔雅登 ® 朔颜 ® 轮廓密码——MD Codes™ 7&9-Point ∑hape™，及全球前沿的专属治疗方案。 全面理解面部结构对于提升面部形态至关重要。作为MD Codes™体系下的轮廓治疗方案， 7&9-Point ∑hape™旨在构建中面部基础，同时塑造下面部轮廓。 [7],[8] 为了使医美需求者获得更加满意的治疗效果，Dr. Mauricio de Maio 提出了适合人们求美需要的情绪美学密码治疗方案，简称MD Codes™。MD Codes™不只是专注于个别治疗部位，更强调治疗的情绪动机，能够协助医生判断面部治疗部位与不同情绪特质的关联，确定合适的注射点位，满足医美需求者治疗后期望，呈现出自然外观的治疗效果。 与会专家纷纷表示，体系完整、具有可重现性并且不断更新迭代的注射技术体系和相关培训，对于医美需求者当下治疗的满意度以及长期、安全、可持续的治疗旅程都具有重要意义。 雕刻立体侧颜，创领行业新趋 一项纳入800例不同年龄、性别的中国人群研究显示，约有60%至80%中国人群具有下颏短小、下颌后缩等问题，严重程度随年龄增长而增加。 [9],[10] 中国整形美容协会面部年轻化分会会长、爱思特医疗美容集团总院长李勤教授 表示：" 亚洲地区的医美需求者对下颌和下颏区域的治疗需求高；同时，下颌、下颏的治疗需求复杂，医生需要谨慎选择具备理想特性的医美产品，包括强支撑能力、抗变形和抗位移能力，以及自然融合度高、安全可靠等。乔雅登 ® 家族丰富的产品组合以及朔颜 ® 强大的产品力，将成为医生能够实现三维全面部美学治疗的基础和保证。" 《中国人群面部年轻化透明质酸填充剂应用指南》指出，下颏和下颌的老化特征包括容量缺失和轮廓模糊，建议使用高弹性模量、中到高内聚力的透明质酸填充剂，在骨膜上或皮下注射，以重塑下颏轮廓和下颌缘线条。 上海上实医疗美容医院副院长方建蔺 表示："当前中国市场缺乏能够塑造从下颏到下颌线整体轮廓的塑形产品，乔雅登 ® 朔颜 ® 的上市恰逢其时，其定制化的弹性模量和内聚力配比符合下颌区域治疗需求。我们期待乔雅登 ® 品牌作为全球品类领导者能够更进一步，树立行业新的治疗标杆并助力实现患者多元化的治疗目标。" 目前，玻尿酸已经成为面部填充和塑形的主流产品之一。产自法国Pringy工厂的乔雅登 ® 朔颜 ® 使用特有的Vycross ® 交联技术，是乔雅登 ® Vycross ® 系列中透明质酸浓度、弹性模量和内聚力最高的产品。 中国注册研究*临床数据显示，使用乔雅登 ® 朔颜 ® 治疗6个月后，下颌部位整体美观改善的满意度高达95.0%以上；在治疗后12个月，医美需求者仍然维持较高的满意度。数据充分证明了乔雅登 ® 朔颜 ® 在改善和塑造下颌线条方面的治疗效果。 乔雅登 ® 家族目前已有6款产品（乔雅登雅致 ® 、乔雅登极致 ® 、丰颜 ® 、缇颜 ® 、质颜 ® 和乔雅登 ® 朔颜 ® ）进入中国市场，涵盖面颊部、鼻唇沟、唇部、鼻部、下颌轮廓等多个部位的治疗，配置不同的理化特性，实现分层分部位定制化解决方案。 1. Ogilvie Petal. Aesthet Surg J. 2020;40:NP499–510. 2. Allergan Aesthetics. Unpublished Data. INT-VOX-2150005. Juvéderm® VOLUX: Final Clinical Evaluation Report 2019. Apr 2021. 3. 吴敏娟,等.下颌骨的生长发育及下面部衰老后的变化[J].中国美容医学,2007,(09):1302-1304. 4. Ozturk C N, et al. Dentition, bone loss, and the aging of the mandible[J]. Aesthetic surgery journal, 2013, 33(7): 967-974. 5. 张陈平. 下颌骨重建术[J]. 口腔颌面外科杂志,2005,15(3):215-218. 6. 恒敏,等. 上下颌骨位置改变对上气道的影响[J]. 口腔颌面外科杂志,2007,17(1):94-97. 7. de Maio M. Facial Plast Surg 2022;38(2):102–10. doi: 10.1055/s-0041-1741499; 2. de Maio M. Aesthetic Plast Surg 2021;45:690–709. doi: 10.1007/s00266-020-01762-7. 8. de Maio M. Facial Plast Surg 2022;38(2):102–10. doi: 10.1055/s-0041-1741499; 2. de Maio M. Aesthetic Plast Surg 2021;45:690–709. doi: 10.1007/s00266-020-01762-7. 9. Hsieh D M Y, et al. Chin microgenia: an anthropometric analysis on the prevalence and severity in a Chinese population[J]. Dermatologic Surgery, 2022, 48(5): 516-522. 10. 2020 BONE CLONES, INC. Human Male and Female Skulls: African, Asian, and European:https://boneclones.com/product/human-male-and-female-skulls-african-asian-and-european-COMP-120-SET 2. Racial Determination using *参与该产品中国临床试验的机构包括北京大学国际医院整形美容外科、北京医院整形外科、华中科技大学同济医学院附属协和医院整形外科、南京大学医学院附属鼓楼医院/南京鼓楼医院烧伤整形外科、南方医科大学南方医院整形美容外科、上海第九人民医院/上海交通大学医学院附属第九人民医院整形外科、中国医学科学院整形外科医院整形外科（排名不分先后，按拼音首字母排序） ### 关于艾尔建美学 艾尔建美学是一家艾伯维旗下的公司，致力于研发、生产和销售一系列领先的美学品牌和产品，覆盖面部美学、身体塑形、整形、皮肤护理等领域。 艾尔建美学拥有独立的研发部门，专注于推进美学领域的突破创新，提供全面、科学的美学产品。 如需更多信息，请登录： https://www.allerganaesthetics.cn/ 。