Dihydroergotamine Mesylate

Tonix appoints two executives with decades of experience successfully launching and commercializing new CNS products Bradley Raudabaugh, MBA, joins as Vice President, Marketing, bringing over 25 years of marketing, sales and product planning experience to Tonix Errol Gould, Ph.D., joins Tonix as Vice President, Medical Affairs, with over 25 years of experience in R&D and medical affairs across a wide range of therapeutic areas, including fibromyalgia New Drug Application (NDA) for TNX-102 SL for the management of fibromyalgia submitted to FDA in October 2024; NDA acceptance expected December 2024; Fast Track designation previously granted by FDA; FDA decision on approval expected 2025 If approved by FDA, TNX-102 SL would be the first member of a new class of analgesic drugs for fibromyalgia and the first new drug for treating fibromyalgia in more than 15 years CHATHAM, N.J., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the expansion of its leadership team to support the launch of TNX-102 SL for the management of fibromyalgia. Bradley Raudabaugh, MBA, has been appointed Vice President, Marketing, and Errol Gould, Ph.D., has been appointed Vice President, Medical Affairs. “We have further strengthened our leadership team with these two strategic hires as we continue to develop our commercial strategies and enhance the potential of our pipeline products. We look forward to leveraging their leadership capabilities and commercial experience as Tonix prepares for the launch of TNX-102 SL for the management of fibromyalgia,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Bradley’s experience in spearheading successful product launches and his deep commercial insights provide us a crucial asset as we prepare to receive a decision from the U.S. Food and Drug Administration (FDA) for our TNX-102 SL NDA in 2025. Similarly, we believe Errol’s experience from working with Tonix since March 2024 as a medical affairs consultant and his vast and well-rounded experience in the development of products in a variety of therapeutic areas will help us continue to build our reputation within the medical community.” Mr. Raudabaugh offers significant leadership experience in building and launching major brands. Most recently, he was the Vice President of Product Strategy at Axsome Therapeutics, where he led the strategic go-to-market planning across five products/indications in psychiatry and neurology. Earlier at Axsome, he led their first commercial launch with Auvelity for the treatment of major depressive disorder, and the integration of Sunosi upon acquisition for the treatment of excessive daytime sleepiness in patients with narcolepsy and sleep apnea. Prior to Axsome, Bradley has held roles of increasing responsibility across marketing, sales, and market access at Insmed, Amgen, Teva, and AstraZeneca. Mr. Raudabaugh holds a Master of Business Administration from the Olin Business School at Washington University in St. Louis and a Bachelor of Arts from Louisiana State University. “This is an exciting time to be joining Tonix as it prepares to receive an FDA decision on its NDA for TNX-102 SL for the management of fibromyalgia,” said Mr. Raudabaugh. “I am ecstatic to work with the Tonix team. We have an opportunity to bring to patients and clinicians the first newly approved drug for fibromyalgia in more than 15 years.” Dr. Gould has over 25 years of experience in research and development and medical affairs across multiple therapeutic areas, including neurology, pain, and sleep, and worked with Tonix as a medical affairs consultant since March 2024. Since 2022, Dr. Gould has served as Head of Medical Affairs in a consultant role at Enalare Therapeutics, developing medical strategy, external messaging and publication plans for its novel respiratory stimulant candidate, ENA-001. Previously, he spent over eight years at Currax Pharmaceuticals, where he ultimately served as Head of Medical and Scientific Affairs. In this role, he led clinical and non-clinical research, developed U.S. and global medical affairs strategies and oversaw medical information for all marketed products. Earlier in his career, Dr. Gould had various medical affairs roles at Synchrony Healthcare Communications, Nuvo Research and Endo Pharmaceuticals. Dr. Gould began his career at GlaxoSmithKline as the Assistant Director in the Metabolism Therapeutic Area and later served on secondment as an Associate Product Manager for the Diabetes Franchise. Dr. Gould holds a Ph.D. in pharmacology from West Virginia University and a Bachelor of Science in biochemistry from the University of Massachusetts-Amherst. He also served as a Research Associate at Hahnemann University and as a Post-Doctoral Fellow/Research Associate at the University of Virginia. “I look forward to partnering with the Tonix team and building upon the Company’s successes to support TNX-102 SL as well as provide medical and strategic insight across the entire Tonix portfolio,” said Dr. Gould. Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. We expect an FDA decision on the acceptance of the NDA for review and a PDUFA date in December 2024 and if accepted, a decision on NDA approval in August 2025 for standard review. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation and its development is supported by a grant from the U.S. National Institute of Drug Abuse and Addiction. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease, including TNX-2900 for Prader-Willi syndrome, and infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. * Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication. Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners. This press release and further information about Tonix can be found at www.tonixpharma.com. Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. Investor Contact Jessica MorrisTonix Pharmaceuticalsinvestor.relations@tonixpharma.com (862) 904-8182 Peter VozzoICR Healthcarepeter.vozzo@westwicke.com (443) 213-0505 Media Contact Ray JordanPutnam Insightsray@putnaminsights.com(949) 245-5432 Indication and UsageZembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age. Important Safety Information Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack: discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes backsevere tightness, pain, pressure, or heaviness in your chest, throat, neck, or jawpain or discomfort in your arms, back, neck, jaw or stomachshortness of breath with or without chest discomfortbreaking out in a cold sweatnausea or vomitingfeeling lightheaded Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem. Do not use Zembrace or Tosymra if you have: history of heart problemsnarrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)uncontrolled high blood pressurehemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.had a stroke, transient ischemic attacks (TIAs), or problems with blood circulationsevere liver problemstaken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.an allergy to sumatriptan or any of the components of Zembrace or Tosymra Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements. Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert. Zembrace and Tosymra may cause serious side effects including: changes in color or sensation in your fingers and toessudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fevercramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feetincreased blood pressure including a sudden severe increase even if you have no history of high blood pressuremedication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.hives (itchy bumps); swelling of your tongue, mouth, or throatseizures even in people who have never had seizures before The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only). Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider. This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633. You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

▎药明康德内容团队编辑 日前，Satsuma Pharmaceuticals宣布，美国FDA已接受其在研鼻腔喷雾剂STS101重新提交的新药申请（NDA），用于急性治疗伴或不伴先兆的偏头痛。该申请的PDUFA日期为2025年4月30日。 偏头痛是神经内科常见疾病之一，虽然不是致命的疾病，但是每当发作时，患者十分痛苦并严重影响生活。双氢麦角胺是一种非选择性5羟色胺1受体激动剂，可以非选择性的刺激5羟色胺1受体，从而阻止急性偏头痛的发生。其药理机制是通过阻止神经源性炎症、中枢敏感化、神经肽释放发挥功能。鼻腔喷雾剂给药具有靶向、高效、速效、毒副作用小的特点，相比其他给药方式，具有使用简便，起效快的优势。 STS101新药申请主要基于两项临床试验的结果支持：一是于2021年6月完成的1期药代动力学和安全性试验，二是ASCEND临床3期长期开放标签安全性试验。在ASCEND试验中，446名受试者总共使用了一万多剂STS101，治疗了超过9000次偏头痛发作，试验持续时间最长达18个月。 图片来源：123RF 该申请中亦包含了1600名受试者参与的双盲、安慰剂对照的SUMMIT临床3期疗效试验的结果。分析显示，STS101在使用后超过2小时的所有时间点（3、4、6、12、24和48小时）上表现出显著且持久的疗效（p<0.001）。此外，STS101在多个次要终点上也表现出显著且持久的抗偏头痛效果，这些终点均符合FDA当前指导文件和国际头痛学会（IHS）关于急性偏头痛发作治疗对照试验指南中的相关建议。 在之前的完整回复函（CRL）中，FDA并未对STS101的临床试验结果或安全性提出质疑，也未要求进行额外的临床试验。然而，FDA提出了关于化学、生产和控制（CMC）方面的意见。 STS101是一种用于急性治疗偏头痛的创新在研疗法。基于已广泛使用的抗偏头痛药物甲磺酸二氢麦角胺（DHE），通过Satsuma专有的鼻部递送设备给药。STS101的设计旨在为患者提供快速且便捷的自我给药方式。Satsuma的鼻用粉末DHE制剂已显示出快速达到血浆药物浓度峰值，血浆药物浓度持续时间长以及多次给药之间差异性低等特点。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放 参考资料： [1] Satsuma Pharmaceuticals and SNBL Receive FDA Acceptance of NDA Resubmission of STS101 for the Acute Treatment of Migraine With or Without Aura. Retrieved November 27, 2024 from https://www.prnewswire.com/news-releases/satsuma-pharmaceuticals-and-snbl-receive-fda-acceptance-of-nda-resubmission-of-sts101-for-the-acute-treatment-of-migraine-with-or-without-aura-302316089.html [2] Satsuma Pharmaceuticals and SNBL Resubmits the New Drug Application for STS101 (Dihydroergotamine Nasal Powder) for the Acute Treatment of Migraine With or Without Aura. Retrieved November 27, 2024 from https://investors.satsumarx.com/2024-10-30-Satsuma-Pharmaceuticals-and-SNBL-Resubmits-the-New-Drug-Application-for-STS101-Dihydroergotamine-Nasal-Powder-for-the-Acute-Treatment-of-Migraine-With-or-Without-Aura [3] Satsuma Pharmaceuticals and SNBL Receive FDA Acceptance of NDA Resubmission of STS101 for the Acute Treatment of Migraine With or Without Aura. Retrieved November 27, 2024 from https://investors.satsumarx.com/2024-11-26-Satsuma-Pharmaceuticals-and-SNBL-Receive-FDA-Acceptance-of-NDA-Resubmission-of-STS101-for-the-Acute-Treatment-of-Migraine-With-or-Without-Aura 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。 分享，点赞，在看，聚焦全球生物医药健康创新