share_log

Tonix Pharmaceuticals Announces Key Findings From Initial Phase of EVERSANA Market Opportunity Analysis for Tonmya for the Management of Fibromyalgia

Tonix Pharmaceuticals Announces Key Findings From Initial Phase of EVERSANA Market Opportunity Analysis for Tonmya for the Management of Fibromyalgia

Tonix Pharmicals公佈了Tonmya纖維肌痛管理EVERSANA市場機會分析初始階段的關鍵發現
Tonix Pharmaceuticals ·  05/21 12:00

Tonix Pharmaceuticals Announces Key Findings from Initial Phase of EVERSANA Market Opportunity Analysis for Tonmya for the Management of Fibromyalgia

Tonix Pharmicals公佈了Tonmya纖維肌痛管理EVERSANA市場機會分析初始階段的關鍵發現

May 21, 2024 8:00am EDT Download as PDF

美國東部時間 2024 年 5 月 21 日上午 8:00 以 PDF 格式下載

Tonmya is a potential new first-line, centrally acting non-opioid analgesic for the management of fibromyalgia, supported by statistically significant results from two Phase 3 trials

Tonmya是一種潛在的新一線、中樞作用的非阿片類鎮痛藥,用於治療纖維肌痛,這得到了兩項3期試驗具有統計學意義的結果的支持

Primary physician research found high level of interest in Tonmya as a potential new treatment option for fibromyalgia

主治醫生的研究發現,人們對Tonmya作爲纖維肌痛潛在的新治療選擇產生了濃厚的興趣

Significant dissatisfaction reported with drugs currently approved by FDA for the treatment of fibromyalgia

據報道,美國食品藥品管理局目前批准的用於治療纖維肌痛的藥物嚴重不滿

Analysis of claims data revealed that addictive opioids are prescribed more frequently than currently approved drugs following fibromyalgia diagnosis

對索賠數據的分析顯示,在纖維肌痛診斷後,處方成癮性阿片類藥物的頻率比目前批准的藥物更頻繁

New Drug Application (NDA) submission to the FDA on track for the second half of 2024

2024年下半年向美國食品藥品管理局提交新藥申請(NDA)的工作有望完成

CHATHAM, N.J., May 21, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that EVERSANA Life Science Services, LLC, a leading provider of commercialization services to the global life sciences industry, completed the initial phase of an assessment of the U.S market opportunity for TonmyaTM (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets), a potential new first line therapy for the management of fibromyalgia. Tonix previously announced that EVERSANA was selected to support the launch strategy and commercial planning of Tonmya. Specifically, EVERSANA is working with Tonix to assess the fibromyalgia landscape and help plan an efficient go-to-market (GTM) strategy.

新澤西州查塔姆,2024 年 5 月 21 日(GLOBE NEWSWIRE)— 託尼克斯製藥控股公司 納斯達克股票代碼:TNXP)(Tonix或公司)是一家完全整合的生物製藥公司,其產品已上市並有候選開發渠道,今天宣佈 EVERSANA 生命科學服務有限責任公司 一家爲全球生命科學行業提供商業化服務的領先提供商,完成了對Tonmya美國市場機會評估的初始階段TM (也稱爲 TNX-102 SL,鹽酸環苯扎林舌下片劑),一種治療纖維肌痛的潛在新一線療法。Tonix此前宣佈,選擇EVERSANA來支持Tonmya的發射戰略和商業規劃。具體而言,EVERSANA正在與Tonix合作評估纖維肌痛格局,並幫助規劃有效的進入市場(GTM)戰略。

"The primary research and analysis conducted by EVERSANA provides valuable insights and informs the vision for the commercialization of Tonmya," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "We are excited to refine our business strategy for the anticipated launch of Tonmya in 2025. It has been approximately fifteen years since patients suffering with fibromyalgia have been provided a new therapeutic option. The market research conducted by EVERSANA with physicians indicates a continued high unmet need, with the need ranked > 4.0 on a 5-point scale."

Tonix Pharmicals首席執行官塞思·萊德曼醫學博士說:“EVERSANA進行的初步研究和分析提供了寶貴的見解,爲Tonmya的商業化願景提供了信息。”“我們很高興能夠爲預計於2025年推出的Tonmya完善我們的業務戰略。自從爲纖維肌痛患者提供新的治療選擇以來,已經過去了大約十五年。EVERSANA對醫生進行的市場研究表明,未得到滿足的需求持續居高不下,按5分制計算,需求排名>4.0。”

Dr. Lederman continued, "We were surprised to learn that opioids dominate the fibromyalgia prescription market, despite the well-known risks of dependency. Opioids are prescribed to more patients following fibromyalgia diagnosis than all the FDA-approved fibromyalgia drugs combined. If approved, we believe that Tonmya can provide a non-opioid, centrally-acting solution for fibromyalgia patients. This is corroborated by EVERSANA's primary market research in which physicians indicated median interest of 4.0 on a 5-point scale and intended use of Tomya in 40% of their fibromyalgia patients, upon approval.1 We look forward to submitting the NDA for Tonmya in the second half of this year and expect an FDA decision on approval in 2025."

萊德曼博士繼續說:“儘管存在衆所周知的依賴風險,但阿片類藥物在纖維肌痛處方市場佔據主導地位,我們感到驚訝。診斷出纖維肌痛後開的阿片類藥物比所有經美國食品藥品管理局批准的纖維肌痛藥物的總和還要多。如果獲得批准,我們相信Tonmya可以爲纖維肌痛患者提供非阿片類藥物的中樞作用的解決方案。EVERSANA的主要市場研究證實了這一點,在該研究中,醫生表示,按5分制計算,Tomya的平均興趣爲4.0,經批准,40%的纖維肌痛患者的預期用途。1 我們期待在今年下半年提交Tonmya的保密協議,並預計美國食品藥品管理局將在2025年做出批准決定。”

EVERSANA's analysis of the market size was based on medical claims databases and epidemiological studies on prevalence and diagnosis2. Primary research with physicians was conducted to test the potential adoption of Tonmya based on its activity and tolerability.

EVERSANA對市場規模的分析基於醫療索賠數據庫和關於患病率和診斷的流行病學研究2。與醫生一起進行了初步研究,根據其活性和耐受性測試了Tonmya的潛在採用率。

Key findings from claims data analyses2:

索賠數據分析的主要發現2:

  • ~2.7 million adults in the U.S. currently diagnosed and treated for fibromyalgia.
    • ~90 percent of patients diagnosed with fibromyalgia are female.
  • Percentage of fibromyalgia patients who were prescribed certain drugs3:
    • FDA-approved fibromyalgia drug prescriptions:
      1. Duloxetine (generic Cymbalta): 23%, pregabalin (generic Lyrica): 13%, and Savella (milnacipran): 1%
    • Off-label drug prescriptions:
      1. Gabapentin: 26%, hydroxycodone: 20%, cyclobenzaprine: 18%, oxycodone: 19%, tramadol: 13%, meloxicam: 12%, and amitriptyline: 6%
    • Off-label opioids prescriptions:
      1. Hydroxycodone: 20%, oxycodone: 19%, and tramadol: 13%
  • Targeted prescriber strategy for launch.
    • High prescribers are rheumatologists, pain medicine specialists, primary care physicians, neurologists, and psychiatrists.
  • ~50 percent of diagnosed fibromyalgia patients are covered by Medicare.
    • Medicare population stands to benefit from a decrease in out-of-pocket prescription drug liability to $2,000 per year when the changes from the Inflation Reduction Act are enacted in 2025.
  • 目前,美國約有270萬成年人被診斷和治療纖維肌痛。
    • 在被診斷患有纖維肌痛的患者中,約有90%是女性。
  • 服用某些藥物的纖維肌痛患者的百分比3:
    • 美國食品藥品管理局批准的纖維肌痛藥物處方:
      1. 度洛西汀(仿製Cymbalta):23%,普瑞巴林(仿製Lyrica):13%,Savella(milnacipran):1%
    • 標籤外的藥物處方:
      1. 加巴噴丁:26%,羥考酮:20%,環苯扎林:18%,羥考酮:19%,曲馬多:13%,美洛昔康:12%,阿米替林:6%
    • 標籤外的阿片類藥物處方:
      1. 羥考酮:20%,羥考酮:19%,曲馬多:13%
  • 推出有針對性的處方藥策略。
    • 處方高者是風溼病學家、疼痛醫學專家、初級保健醫生、神經科醫生和精神科醫生。
  • 在確診的纖維肌痛患者中,約有50%由醫療保險承保。
    • 2025年頒佈《減少通貨膨脹法》的變更後,自付處方藥負債將降至每年2,000美元,醫療保險人口將從中受益。

Key findings from primary physician research4:

初級醫生研究的主要發現4:

  • High level of dissatisfaction with currently prescribed drugs.
    • Physicians interviewed estimate that 85% of their patients fail first-line therapy due to efficacy and tolerability issues and 79% of their patients are on multiple therapies.
    • Prescribers indicate high unmet need in fibromyalgia, ranked >4.0 on a 5-point scale.
  • High level of interest in Tonmya from physicians interviewed as a potential new treatment option based on favorable activity and tolerability profile observed in Tonmya fibromyalgia clinical studies.
    • Median interest in Tonmya of 4 on a 5-point scale.
    • Physicians indicated intended use of Tonmya in 40% of their fibromyalgia patients.1
  • 對目前處方藥的不滿程度很高。
    • 受訪醫生估計,85%的患者因療效和耐受性問題而未能通過一線治療,79%的患者正在接受多種療法。
    • 處方者表示,纖維肌痛的需求未得到滿足,按5分制計算,排名>4.0。
  • 根據Tonmya纖維肌痛臨床研究中觀察到的良好活性和耐受性,接受採訪的醫生對Tonmya作爲潛在的新治療選擇產生了濃厚的興趣。
    • 按5分制計算,對Tonmya的興趣中位數爲4。
    • 醫生表示,40% 的纖維肌痛患者有意使用Tonmya。1

Tonmya is a centrally acting, non-opioid medication. As previously announced, Tonix's second statistically significant Phase 3 study, RESILIENT, met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results (p=0.001 or better) were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function.

Tonmya 是一種中樞作用的非阿片類藥物。正如先前宣佈的那樣,Tonix的第二項具有統計學意義的3期研究——RESILIENT達到了其預先規定的主要終點,與安慰劑(p=0.00005)相比,顯著減輕了纖維肌痛參與者的日常疼痛(p=0.00005)。在與改善睡眠質量、減輕疲勞以及改善整體纖維肌痛症狀和功能有關的所有關鍵次要終點中也出現了具有統計意義且具有臨床意義的結果(p=0.001 或更好)。

Tonix plans to submit an NDA to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for Tonmya for the management of fibromyalgia and has scheduled a Type B pre-NDA meeting with FDA for the second quarter of 2024.

Tonix計劃在2024年下半年向美國食品藥品監督管理局(FDA)提交Tonmya的纖維肌痛管理保密協議,並計劃在2024年第二季度與美國食品藥品監督管理局(FDA)舉行B型保密協議前會議。

1 40% was the median preference share among physicians interviewed, assuming no market access barriers.
2EVERSANA analysis of claims database, May 2024; commissioned by Tonix
3Note: the total number of patients is greater than 100% because of switching between medications and polypharmacy.
4EVERSANA primary physician research, May 2024; commissioned by Tonix

1 40% 是中位數 優先權共享 其中 醫師們 接受採訪, 假設沒有市場準入壁壘。
2EVERSANA 索賠數據庫分析,2024 年 5 月;由 Tonix 委託
3注意: 由於在藥物和多藥之間切換,患者總數大於 100%
4EVERSANA 主治醫生 研究,2024 年 5 月;由 Tonix 委託

About Tonmya* (also known as TNX-102 SL)

關於 Tonmya*(也稱爲 TNX-102 SL)

Tonmya is a centrally acting, non-opioid, non-addictive, bedtime medication. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia. In December 2023, the company announced highly statistically significant and clinically meaningful topline results in RESILIENT, a second positive Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. RELIEF, the first positive Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints.

Tonmya 是一種中樞作用、非阿片類藥物、不會上癮的睡前藥物。該片劑是鹽酸環苯扎林的專利舌下配方,專爲治療纖維肌痛而開發。2023年12月,該公司公佈了第二項用於治療纖維肌痛的Tonmya陽性3期臨床試驗 “RESILIENT” 的具有高度統計學意義且具有臨床意義的關鍵結果。在這項研究中,Tonmya達到了其預先規定的主要終點,與安慰劑(p=0.00005)相比,纖維肌痛參與者的日常疼痛顯著減輕。在與改善睡眠質量、減輕疲勞以及改善整體纖維肌痛症狀和功能有關的所有關鍵次要終點中也看到了具有統計意義且具有臨床意義的結果。RELIEF是Tonmya治療纖維肌痛的首項3期陽性試驗,於2020年12月完成。與安慰劑相比,它達到了預先規定的每日減輕疼痛的主要終點(p=0.010),並在關鍵次要終點顯示出活性。

*Tonmya is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

*Tonmya 被美國食品藥品監督管理局 (FDA) 有條件地接受 TNX-102 SL 的商品名,用於治療纖維肌痛。Tonmya尚未獲得任何適應症的批准。

About EVERSANA

關於 EVERSANA

EVERSANA is a leading independent provider of global services to the life sciences industry. The company's integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 650 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and X.

EVERSANA是生命科學行業全球服務的領先獨立提供商。該公司的綜合解決方案植根於患者體驗,涵蓋產品生命週期的各個階段,爲患者、處方者、渠道合作伙伴和付款人提供長期、可持續的價值。該公司爲650多個組織提供服務,包括創新型初創企業和知名製藥公司,以推進生命科學解決方案,創造一個更健康的世界。要了解有關 EVERSANA 的更多信息,請訪問 eversana.com 或通過以下方式連接 領英X

Tonix Pharmaceuticals Holding Corp.*

託尼克斯製藥控股公司*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix's development portfolio is focused on central nervous system (CNS) disorders. Tonix's priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two positive Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix's CNS portfolio includes TNX-1300 (cocaine esterase) a biologic designed to treat cocaine intoxication with Breakthrough Therapy designation. Tonix's immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a 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 and infectious disease. 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是一家完全整合的生物製藥公司,專注於開發、許可和商業化治療和預防人類疾病並減輕痛苦的療法。Tonix的開發產品組合側重於中樞神經系統(CNS)疾病。Tonix的首要任務是在2024年下半年向美國食品藥品管理局提交Tonmya的新藥申請(NDA)。Tonmya的候選產品已經完成了兩項針對纖維肌痛管理的陽性3期研究。TNX-102 SL也在開發中,用於治療急性應激反應以及纖維肌痛型的長冠狀病毒。Tonix 的中樞神經系統產品組合包括 TNX-1300(可卡因酯酶),這是一種旨在治療可卡因中毒的生物製劑,其名稱爲 “突破性療法”。Tonix 的免疫學開發產品組合包括用於解決器官移植排斥反應、自身免疫和癌症的生物製劑,包括 TNX-1500,這是一種靶向 CD40 配體(CD40L 或 CD154)的人源化單克隆抗體,正在開發用於預防同種異體移植排斥反應和治療自身免疫性疾病。Tonix還在罕見病和傳染病領域開發候選產品。我們的商業子公司Tonix Medicines銷售3毫克的Zembrace SymTouch(舒馬曲坦注射液)和10毫克的Tosymra(舒馬曲坦鼻腔噴霧劑),用於治療成人有或沒有先兆的急性偏頭痛。

*Tonix's product development candidates are investigational new drugs or biologics and have not been approved for any indication.

*Tonix 的候選產品開發是研究性新藥或生物製劑,尚未獲得任何適應症的批准。

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

Zembrace SymTouch 和 Tosymra 是 Tonix Medicines 的註冊商標。所有其他商標均爲其各自所有者的財產。

This press release and further information about Tonix can be found at www.tonixpharma.com.

本新聞稿和有關 Tonix 的更多信息可在以下網址找到 www.tonixpharma.com

Forward-Looking Statements

前瞻性陳述

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 commercialize 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.

根據1995年《私人證券訴訟改革法》,本新聞稿中的某些陳述是前瞻性的。這些陳述可以通過使用前瞻性詞語來識別,例如 “預期”、“相信”、“預測”、“估計”、“預期” 和 “打算” 等。這些前瞻性陳述基於Tonix當前的預期,實際業績可能存在重大差異。有許多因素可能導致實際事件與此類前瞻性陳述所表明的事件存在重大差異。這些因素包括但不限於與未能獲得美國食品藥品管理局許可或批准以及不遵守美國食品藥品管理局法規相關的風險;與我們的任何產品未能成功商業化相關的風險;與候選產品臨床開發的時間和進展相關的風險;我們對額外融資的需求;專利保護和訴訟的不確定性;政府或第三方付款人補償的不確定性;研發工作有限以及對第三方的嚴重依賴;以及對第三方的嚴重依賴競爭。與任何正在開發的藥物一樣,新產品的開發、監管批准和商業化也存在重大風險。Tonix沒有義務更新或修改任何前瞻性陳述。投資者應閱讀2024年4月1日向美國證券交易委員會(“SEC”)提交的截至2023年12月31日年度的10-K表年度報告以及該報告當天或之後向美國證券交易委員會提交的定期報告中列出的風險因素。Tonix的所有前瞻性陳述均受所有這些風險因素和其他警示性陳述的明確限制。此處提供的信息僅反映截至發佈之日的信息。

Investor Contact

投資者聯繫人

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

傑西卡莫里
託尼克斯製藥
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

彼得·沃佐
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

媒體聯繫人

Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

凱蒂道奇
Lavoie 健康科學
kdodge@lavoiehealthscience.com(978) 360-3151

Matt Braun
EVERSANA
Matt.braun@eversana.com

馬特·布勞恩
EVERSANA
Matt.braun@eversana.com


Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.
來源:Tonix 製藥控股公司

Released May 21, 2024

2024 年 5 月 21 日發佈

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
    搶先評論