Nimodipine

脑鸣的最新治疗进展有哪些？ 脑鸣（或称颅鸣）作为一种主观感知的颅内异常声响，其治疗已从传统的单一模式发展为多元化、精准化的综合干预体系。根据最新的临床研究与实践，其治疗进展主要体现在以下几个方面： 一、药物治疗的精准化与新型药物探索 药物治疗仍是基础，但应用更加精准，并不断有新药被探索。 1. 针对病因的精准用药：根据脑鸣的不同病因，药物选择更具针对性。对于血管性或脑循环障碍引起的脑鸣，改善微循环药物如银杏叶提取物仍是主流选择，研究显示其能缓解约62%患者的症状。对于合并焦虑、抑郁等精神心理因素的患者，抗焦虑抑郁药物如氟西汀、帕罗西汀等被证实能有效改善情绪并缓解脑鸣，有效率可达78%。对于神经损伤或营养问题，甲钴胺等神经营养药物被广泛应用。 2. 新型药物研发：除了上述经典药物，一些调节神经兴奋性的药物如加巴喷丁、普瑞巴林，以及改善内耳循环的尼莫地平、氟桂利嗪等，也在临床中显示出潜力。未来，更多针对特定神经递质通路或具有神经保护作用的新型药物正在研发中。 二、物理治疗技术的创新与突破 非侵入性物理治疗取得了显著进展，为患者提供了更多选择。 1. 经颅磁刺激（TMS）技术：这是近年来最受关注的进展之一。通过磁场无创地刺激大脑特定区域，调节异常的神经活动。2024年的研究显示，重复TMS治疗8周后，患者脑鸣评分平均可降低42%。该技术特别适合早期或神经功能紊乱引起的脑鸣，但通常需要较长的疗程（20-30次）。 2. 声治疗与习服疗法：通过使用白噪音、特定频率声音或定制化音乐进行掩蔽和脱敏训练，帮助大脑逐渐适应并忽略脑鸣声。这种方法结合冥想、放松训练，被形象地称为给大脑做“声音瑜伽”，对约35%的轻度患者有效。 3. 其他物理疗法：如高压氧治疗（改善内耳缺氧）、生物反馈训练（控制相关肌肉紧张）、颈部按摩与热敷（针对颈椎病因）等，也作为综合治疗的一部分被广泛应用。 三、外科手术的精准应用与价值重估 对于由明确器质性病变引起的顽固性脑鸣，手术治疗的价值更加凸显。 1. 明确的适应症：当脑鸣由听神经瘤、血管畸形（如动静脉瘘）、明确的血管压迫神经（如三叉神经痛伴脑鸣） 等引起时，手术成为首选。例如，听神经瘤显微手术后，90%的患者脑鸣在3个月内显著缓解；微血管减压术能使76%的相关患者脑鸣强度下降50%以上。 2. 技术创新：手术技术本身也在进步。例如，针对颈内静脉狭窄等血管问题导致的脑鸣，已有团队通过寰椎横突磨除联合松解等外科技术成功治疗，证实了外科干预在特定病理中的价值。 四、多学科联合诊疗（MDT）模式的普及 这是现代脑鸣治疗的核心理念和重要进展。由于脑鸣病因涉及神经内科、耳鼻喉科、精神心理科、康复科、骨科乃至心血管科等多个领域，单一的科室难以全面处理。 * MDT模式整合各科专家，为患者制定个性化治疗方案。例如，对耳鸣合并颈椎病的患者，联合颈椎牵引和认知行为治疗，6个月有效率可达89%。国内一些顶级三甲医院已建立专门的脑鸣MDT门诊，使复杂病例的治疗周期平均缩短了40%。 五、生活方式干预与心理治疗的深度融合 认识到心理社会因素的关键作用，治疗中更加强调身心同治。 1. 认知行为疗法（CBT）：帮助患者改变对脑鸣的错误认知和灾难化思维，减少焦虑，打破“脑鸣-焦虑-脑鸣加重”的恶性循环。 2. 生活方式管理：规律作息、避免熬夜、减少咖啡因和酒精摄入、适度有氧运动、控制盐分和血脂等，被证实是有效的辅助治疗手段，对于轻度患者甚至可能实现症状缓解。 六、未来前沿治疗方向的展望 研究正在向更根源、更精准的领域探索。 1. 基因治疗与干细胞治疗：虽然尚处于临床试验阶段，但为难治性脑鸣带来了根本性治愈的希望。例如，2024年有研究报道间充质干细胞移植使部分患者耳鸣相关生活质量评分提升37%。基因编辑技术则试图从遗传层面解决问题。 2. 精准诊断技术：借助高分辨率脑电图、功能磁共振成像等多模态技术，未来有望更精准地定位导致脑鸣的异常神经活动脑区，从而实现靶向治疗。 总结而言，脑鸣的最新治疗进展呈现出 “综合化、精准化、个性化” 的鲜明趋势。治疗不再局限于单一药物，而是根据具体病因（血管性、神经性、心理性、器质性），灵活组合药物治疗、创新物理治疗（如TMS）、必要的外科手术、深度心理干预以及严格的生活方式管理，并通过多学科协作（MDT） 模式来制定和执行方案。患者若受脑鸣困扰，建议前往设有耳鸣专科或神经内科的大型三甲医院就诊，进行系统评估，以获得最适合当前医学进展的个性化治疗方案。

FDA Established April 23, 2026 as PDUFA Target Date for Review of Submission Seeking Approval for GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH) Phase 3 STRIVE-ON Safety Trial Data Presented at 2025 Society of Vascular and Interventional Neurology Annual Meeting Company Continues Pre-Commercial Planning in Anticipation of Potential FDA Approval of NDA Submission for GTx-104 for the Treatment of Patients with aSAH PRINCETON, N.J., Feb. 12, 2026 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aSAH patients, today announced the financial results and business highlights for the quarter ended December 31, 2025. “During our third quarter of fiscal 2026 we continued to execute on our clinical and corporate goals, led by our pre-commercial planning in anticipation of potential FDA approval of our New Drug Application (NDA) for GTx-104 for the treatment of aSAH,” said Prashant Kohli, CEO of Grace Therapeutics. “Our NDA is supported by a robust data package, including positive results from our STRIVE-ON trial, which provided evidence of improved clinical outcomes in aSAH patients treated with GTx-104 as well as potential medical and pharmacoeconomic benefits of GTx-104 in the treatment of aSAH. We were pleased to see these data highlighted in a late breaking presentation at the Society of Vascular and Interventional Neurology annual meeting in November 2025. Our STRIVE-ON trial results continue to be well received by researchers, practitioners and industry leaders. We believe that if our NDA for GTx-104 is approved by the FDA, our strong U.S. and international patent estate will help to maximize the long-term market value of GTx-104 and correspondingly deliver value for our shareholders. The standard of care for aSAH has not seen meaningful innovation in nearly 40 years, and we believe that if GTx-104 is approved, our STRIVE-ON trial results point to a very promising role for GTx-104 in the treatment of these patients. We look forward to continuing to engage with the FDA during their review as they work toward the PDUFA target date of April 23, 2026.” Third Quarter 2026 and Recent Corporate Highlights During our third fiscal quarter we provided grant support for the development of a Continuing Medical Education (CME) program for healthcare professionals in medical specialties related to the care of aSAH patients. Content for the CME program was independently developed by leading providers of CME content and is intended to educate Health Care Professionals on the current challenges in treating aSAH patients. On November 21, 2025, the Company presented data from its pivotal Phase 3 STRIVE-ON Safety Trial of GTx-104 in aSAH as a late breaking trial at the Society of Vascular and Interventional Neurology annual meeting. The presentation titled Safety and Tolerability of GTX-104 (Nimodipine Injection for IV Infusion) Compared with Oral Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage: a Prospective, Randomized Trial, was presented by Thomas P. Bleck, MD, Professor, Neurology (Neurocritical Care and Epilepsy/Clinical Neurophysiology) at Northwestern University Feinberg School of Medicine. On October 23, 2025, the Company announced that it had secured approximately $4.0 million in additional funding through exercises of common warrants that were previously issued in a private placement that the Company closed in September 2023. The Company issued 1,345,464 new shares of common stock at an exercise price of $3.003 per share. The remaining 1,190,927 common warrants issued in the 2023 private placement expired on October 21, 2025. Third Quarter 2026 Financial Results The Company reported a net loss of approximately $2.3 million, or $0.14 per share, for the three months ended December 31, 2025, a decrease of approximately $1.8 million from the net loss of $4.2 million, or $0.36 per share, for the three months ended December 31, 2024. The decrease in net loss was primarily due to a $1.7 million decrease in research and development expenses and a $1.1 million decrease in the change of fair value of derivative warrant liabilities, partially offset by increases in general administrative expenses of $0.5 million and a decrease in income tax benefit of $0.6 million. Total research and development expenses for the three months ended December 31, 2025, were $0.5 million, compared to $2.2 million for the three months ended December 31, 2024. The decrease of $1.7 million was primarily due to a $1.8 million decrease in research activities mainly due to completion of our GTx-104 pivotal Phase 3 STRIVE-ON safety clinical trial, partially offset by a $0.1 million increase in salaries and benefits due to merit increases. General and administrative expenses were $2.0 million for the three months ended December 31, 2025, an increase of $0.5 million from $1.5 million for the three months ended December 31, 2024. The increase was primarily a result of an increase in professional fees and other general and administrative expenses primarily due to costs for GTx-104 pre-commercial planning. Cash Runway As of December 31, 2025, cash and cash equivalents were $18.7 million, a net decrease of $3.4 million compared to cash and cash equivalents of $22.1 million at March 31, 2025. The private placement the Company completed in February 2025 included common warrants exercisable for shares of common stock (or pre-funded warrants in lieu thereof) at an exercise price of $3.395 per share. Each common warrant is immediately exercisable and will expire on the earlier of (i) the 60th day after the date the FDA approves the NDA for GTx-104 and (ii) September 25, 2028. Potential gross proceeds from the exercise of the February 2025 common warrants are $15.0 million. The Company plans to use its current cash and cash equivalents to further the regulatory review process for GTx-104, pre-commercial planning, commercial team buildout, and product launch if GTx-104 is approved, working capital and other general corporate purposes. The Company believes its existing cash and cash equivalents will be sufficient to sustain planned operations through at least 12 months from the date of this press release. About the STRIVE-ON Trial The STRIVE-ON trial ( NCT05995405 ) was a prospective, randomized open-label trial of GTx-104 compared with oral nimodipine in patients hospitalized with aSAH. 50 patients were administered GTx-104 and 52 patients received oral nimodipine. The primary endpoint was the number of patients with at least one episode of clinically significant hypotension reasonably considered to be caused by the drug, and additional secondary endpoints included safety, clinical, and pharmacoeconomic outcomes. The trial met its primary endpoint, with patients receiving GTx-104 observed to have a 19% reduction in at least one incidence of clinically significant hypotension compared to oral nimodipine (28% versus 35%). Other measures also favored GTx-104 or were comparable between GTx-104 and oral nimodipine, including: 54% patients on GTx-104 had relative dose intensity (RDI) of 95% or higher compared to only 8% on oral nimodipine, and 29% more patients on GTx-104 than on oral nimodipine had favorable functional outcomes at 90 days. In addition, there were fewer intensive care unit (ICU) readmissions, ICU days, and ventilator days for patients receiving GTx-104 versus oral nimodipine. Adverse events were comparable between the two arms and no new safety issues were identified with patients receiving GTx-104. All deaths in both arms of the trial were due to severity of the patient’s underlying disease. There were eight deaths on the GTx-104 arm compared to four deaths on the oral nimodipine arm. The survival status of one patient on the oral nimodipine arm was unknown. No deaths were determined to be related to GTx-104 or oral nimodipine. 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 in the brain. The result is aSAH, a relatively uncommon type of stroke that accounts for about 5% of all strokes and an estimated 42,500 U.S. hospital treated patients. About the Grace Therapeutics Asset Portfolio GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for 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 200 patients and healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine. 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 Company received written responses to its End of Phase 1 meeting in GTx-102 where the FDA made recommendations on the path toward an NDA. The FDA provided guidance on the design of a single pivotal efficacy and safety trial, including the neurological assessment scale for the primary endpoint, that could, with appropriate confirmatory evidence, support an NDA. The further development of GTx-102 has been deprioritized in favor of focusing on development of GTx-104. It is also possible that the Company may license or sell GTx-102. 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, which are used for the treatment of PHN, the Company believes 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 focusing on development of GTx-104. It is also possible that the Company may license or sell GTx-101. About Grace Therapeutics Grace Therapeutics, Inc. (Grace Therapeutics or the Company) is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Grace Therapeutics’ 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 Therapeutic’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 if certain conditions are met at NDA approval, and additional intellectual property protection with over 40 granted and pending patents. Grace Therapeutics’ lead clinical asset, GTx-104, is an IV 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: 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 Company’s cash runway and cash position, the future prospects of the Company’s GTx-104 drug candidate, the outcome of the Company’s NDA submission for GTx-104, GTx-104’s potential to bring enhanced treatment options to patients suffering from aSAH, GTx-104’s potential to be administered to improve the management of hypotension in patients with aSAH, the ability of GTx-104 to achieve a pharmacokinetic and safety pro to the oral form of nimodipine, GTx-104’s potential to achieve medical and pharmacoeconomic benefit, GTx-104’s commercial prospects, the future prospects of the Company’s GTx-102 drug candidate, GTx-102’s potential to provide clinical benefits to decrease symptoms associated with A-T, the timing and outcomes of a Phase 3 efficacy and safety trial for GTx-102, the timing of an NDA filing for GTx-102, the future prospects of the Company’s GTX-101 drug candidate, GTX-101’s potential to be administered to PHN patients to treat the severe nerve pain associated with the disease and any future patent and other intellectual property filings made by the Company for new developments, are based upon Grace Therapeutics’ 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 of the Company’s NDA submission for GTx-104; (iii) changes to regulatory pathways; (iv) our ability to protect our intellectual property for our drug candidates; and (v) legislative, regulatory, political and economic developments. 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 the “Special Note Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2025, the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025, the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025 and the Company’s Quarterly Report on Form 10-Q for the quarterly period ended December 31, 2025, to be filed with the Securities and Exchange Commission (“SEC”) and other documents that have been and will be filed by Grace Therapeutics from time to time with the SEC 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 Kohli Chief Executive Officer Tel: 609-322-1602 Email: info@gracetx.com Investor Relations: LifeSci Advisors Mike Moyer Managing Director Phone: 617-308-4306 Email: mmoyer@lifesciadvisors.com ---tables to follow--- GRACE THERAPEUTICS, INC. Condensed Consolidated Balance Sheets (Unaudited) December 31, 2025 March 31, 2025 (Expressed in thousands except share data) $ $ Assets Current assets: Cash and cash equivalents 18,672 22,133 Receivables 20 126 Prepaid expenses 519 453 Total current assets 19,211 22,712 Equipment, net 11 15 Intangible assets 41,128 41,128 Goodwill 8,138 8,138 Total assets 68,488 71,993 Liabilities and Stockholders’ equity Current liabilities: Trade and other payables 1,284 1,930 Total current liabilities 1,284 1,930 Derivative warrant liabilities - 1,141 Deferred tax liability 2,312 2,312 Total liabilities 3,596 5,383 Commitments and contingencies Stockholders’ equity: Preferred stock, $0.0001 par value per share; 10,000,000 authorized; none issued and outstanding as of December 31, 2025 and March 31, 2025 — — Common stock, $0.0001 par value per share; 100,000,000 authorized; 15,474,026 and 13,718,106 shares issued and outstanding as of December 31, 2025 and March 31, 2025, respectively 1 1 Additional paid-in capital 298,231 293,334 Accumulated other comprehensive loss (6,038 ) (6,038 ) Accumulated deficit (227,302 ) (220,687 ) Total stockholders’ equity 64,892 66,610 Total liabilities and stockholders’ equity 68,488 71,993 GRACE THERAPEUTICS, INC. Condensed Consolidated Statements of Loss and Comprehensive Loss (Unaudited) Three months ended Nine months ended December 31, 2025 December 31, 2024 December 31, 2025 December 31, 2024 (Expressed in thousands, except share and per share data) $ $ $ $ Operating expenses Research and development expenses, net of government assistance (462 ) (2,194 ) (1,985 ) (7,877 ) General and administrative expenses (1,987 ) (1,510 ) (6,082 ) (5,619 ) Loss from operating activities (2,449 ) (3,704 ) (8,067 ) (13,496 ) Foreign exchange gain (loss) 4 (16 ) 5 (11 ) Change in fair value of derivative warrant liabilities (40 ) (1,178 ) 900 578 Interest and other income, net 170 138 547 544 Total other income (loss), net 134 (1,056 ) 1,452 1,111 Loss before income tax recovery (2,315 ) (4,760 ) (6,615 ) (12,385 ) Income tax benefit — 605 — 2,181 Net loss and total comprehensive loss (2,315 ) (4,155 ) (6,615 ) (10,204 ) Basic and diluted loss per share (0.14 ) (0.36 ) (0.41 ) (0.89 ) Weighted-average number of shares outstanding 16,933,620 11,506,234 16,262,111 11,506,234