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Satsuma Pharmaceuticals and SNBL Announce Five Abstracts on STS101 for the Acute Treatment of Migraine to Be Presented at the American Headache Society's 66th Annual Scientific Meeting

Satsuma Pharmaceuticals and SNBL Announce Five Abstracts on STS101 for the Acute Treatment of Migraine to Be Presented at the American Headache Society's 66th Annual Scientific Meeting

Satsuma Pharmaceuticals和SNBL宣佈將在美國頭痛學會第66屆年會上展示關於STS101用於急性治療偏頭痛的五篇摘要。
PR Newswire ·  06/13 20:00

DURHAM, N.C., June 13, 2024 /PRNewswire/ -- Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company currently seeking regulatory approval from the U.S. Food and Drug Administration for STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395), today announced that five abstracts describing efficacy and safety results from the STS101 Phase 3 clinical study program were selected for presentation at the American Headache Society's (AHS) 66th Annual Scientific Meeting. The 2024 meeting will be held at the Marriott Marquis San Diego Marina, San Diego, CA from Thursday, June 13 to Sunday, June 16, 2024, including the option of participants attending virtually. Full abstracts are now available on the AHS website and will be published in the journal Headache.

Satsuma藥品公司和其母公司新日本生物醫藥實驗室(TSE:2395),是一家初晚期生物醫藥公司,目前正在向美國食品和藥物管理局申請審批STS101(雙氫麥角胺(DHE)鼻粉),一種新的治療偏頭痛急性期的藥物候選品,今天宣佈,五篇描述STS101第三期臨床研究計劃療效和安全性結果的摘要被選爲美國頭痛協會(AHS)第66次年度科學會議的報告。2024年會議將於6月13日星期四至6月16日星期日在聖地亞哥的萬豪輪廓酒店舉行,與會者可以選擇虛擬參加。完整的摘要現已在AHS網站上公開,並將在雜誌Headache上發表。th文稿報告具體情況:《頭痛》.

Poster Presentation Details:

海報展示細節:

Title:

Subjects View Use of STS101 Favorably: Subject Impression Data From the Phase 3 Open-Label ASCEND Study

Presenter:

Jessica Ailani, MD

Poster:

P-608

Date:

Friday, June 14, 2024

Time:

5:00 PM – 6:15 PM PT (8:00 PM – 9:15 PM ET)

標題:

受試者喜歡使用STS101:來自ASCEND第三期開放標籤研究的受試者印象數據

報告人:

Jessica Ailani,MD

海報:

P-608

日期:

2024年6月14日星期五

時間:

PT下午5:00 - 6:15(ET晚上8:00 - 9:15)

Title:

STS101 (Dihydroergotamine Nasal Powder) Shows Pain Relief in Difficult to Treat Migraine Attacks: Results From the Phase 3 Double-blind, Randomized, Placebo-controlled SUMMIT Study

Presenter:

Jessica Ailani, MD

Poster:

P-609

Date:

Thursday, June 13, 2024

Time:

6:00 PM – 7:30 PM PT (9:00 PM – 10:30 PM ET)

標題:

STS101(雙氫麥角胺鼻粉)顯示對難治性偏頭痛發作具有鎮痛作用:來自第三期雙盲、隨機、安慰劑對照SUMMIT研究的結果

報告人:

Jessica Ailani,MD

海報:

P-609

日期:

2024年6月13日,星期四

時間:

PT晚上6:00 - 7:30(ET晚上9:00 - 10:30)

Title:

STS101 (Dihydroergotamine Nasal Powder) Shows Long Duration Anti-Migraine Benefit on Baseline Photophobia, Phonophobia, and Nausea: Results from the Phase 3 Double-blind, Randomized, Placebo-controlled SUMMIT Study

Presenter:

Christopher Gottschalk, MD

Poster:

P-611

Date:

Thursday, June 13, 2024

Time:

6:00 PM – 7:30 PM PT (9:00 PM – 10:30 PM ET)

標題:

STS101(雙氫麥角胺鼻粉)顯示對基線畏光症、畏音症和噁心具有長期抗偏頭痛益處:來自第三期雙盲、隨機、安慰劑對照SUMMIT研究的結果

報告人:

Christopher Gottschalk,MD

海報:

P-611

日期:

2024年6月13日,星期四

時間:

PT晚上6:00 - 7:30(ET晚上9:00 - 10:30)

Title:

STS101 Demonstrated Long-Term Clinical Benefit in the Phase 3 Open-Label ASCEND Study

Presenter:

Larry Charleston, IV, MD

Poster:

P-612

Date:

Friday, June 14, 2024

Time:

5:00 PM – 6:15 PM PT (8:00 PM – 9:15 PM ET)

標題:

在第3期開放標籤ASCEND研究中,STS101展示了長期的臨床效益。

報告人:

Larry Charleston, IV, 醫學博士

海報:

P-612

日期:

2024年6月14日星期五

時間:

太平洋時間下午5點至6:15(東部標準時間晚上8點至9:15)

Title:

Long-Term Safety and Tolerability Data of STS101 From the Phase 3 Open-Label ASCEND Study

Presenter:

Stewart J. Tepper, MD

Poster:

P-693

Date:

Thursday, June 13, 2024

Time:

6:00 PM – 7:30 PM PT (9:00 PM – 10:30 PM ET)

標題:

來自第3期開放標籤ASCEND研究的STS101的長期安全性和耐受性數據

報告人:

Stewart J. Tepper, 醫學博士

海報:

P-693

日期:

2024年6月13日,星期四

時間:

太平洋時間下午6點至7:30(東部標準時間晚上9點至10:30)

About Satsuma and STS101

關於Satsuma和STS101

Satsuma Pharmaceuticals, a wholly-owned subsidiary of Shin Nippon Biomedical Laboratories, Ltd. (SNBL), is a late-stage biopharmaceutical company that is currently seeking regulatory approval from the U.S. Food and Drug Administration for STS101, a novel, investigational therapeutic product for the acute treatment of migraine. STS101 is a unique and proprietary nasal powder formulation of the well-established anti-migraine drug, dihydroergotamine mesylate (DHE), administered via Satsuma's proprietary nasal delivery device. STS101 is designed to provide patients the combination of quick and convenient self-administration. Satsuma's nasal powder DHE formulation has demonstrated fast absorption, rapid achievement of high DHE plasma concentrations, sustained DHE plasma levels over time and low dose-to-dose variability.

Satsuma Pharmaceuticals是Shin Nippon Biomedical Laboratories,Ltd.(SNBL)的全資子公司,是一家處於後期生物製藥階段的公司,目前正在尋求美國食品和藥物管理局對STS101進行監管批准,STS101是一種新穎的、研究性的治療產品,用於急性偏頭痛的治療,是一種獨特的、專有的DHE鼻粉製劑,經過Satsuma專有的鼻腔遞送設備給藥。STS101旨在爲患者提供快速、方便的自我給藥方案。Satsuma的鼻腔粉劑DHE製劑已經證明具有快速吸收、快速達到高DHE血漿濃度、時間持續的DHE血漿水平以及低劑量間變異性等優點。Satsuma總部位於北卡羅來納州的Research Triangle Park。有關更多信息,請訪問。

Satsuma is headquartered in Research Triangle Park, North Carolina. For further information, please visit .

關於SNBL

About SNBL

信立泰生物醫學實驗室股份有限公司(“SNBL”)(TSE:2395)是一家上市的合同研究組織(CRO),成立於1957年於日本鹿兒島。SNBL的公司使命已經是支持藥物開發和醫療技術改進,以解救人類的痛苦。基於公司使命,以及作爲日本最古老和最成熟的CRO的卓越記錄,SNBL很自豪地成爲日本唯一一家可以爲製藥公司、生物科技風險、大學和研究機構提供全面的藥物發現和開發服務和解決方案的公司。 SNBL的轉化研究業務已從事藥物研發,重點是業務發展和專有鼻腔遞送技術和鼻腔裝置的外部許可。SNBL還經營Medipolis Business,利用其在日本鹿兒島縣指宿市擁有的大部分森林地(約900英畝)進行地熱發電和醫療服務業務,以在促進當地經濟和環境保護方面爲人民的福祉、改善生活質量和幸福做出貢獻。有關更多信息,請訪問。諮詢:SHIN NIPPON BIOMEDICAL LABORATORIES,LTD. IR & Corporate Communications([email protected])

Shin Nippon Biomedical Laboratories, Ltd. ("SNBL") (TSE:2395) is a listed contract research organization (CRO) that was founded in Kagoshima, Japan, in 1957. SNBL's corporate mission has been to support drug development and the improvement of medical technology to free mankind from suffering. Based on its corporate mission, and with a proven record of accomplishment as the oldest and established CRO in Japan, SNBL is proud to be the only company in Japan that can provide a comprehensive portfolio of services and solutions for drug discovery and development for pharmaceutical companies, biotech ventures, universities, and research institutions both in Japan and overseas. The SNBL's Translational Research Business has engaged in drug discovery, with the focus on business development and out-licensing of its proprietary intranasal drug delivery technologies and intranasal devices. SNBL also operates the Medipolis Business, making use of 900 acres of land, mostly forests it owns in Ibusuki-City in Kagoshima prefecture, to promote the local economy and environmental conservation at the same time thorough its geothermal power generation and hospitality businesses including Proton Center for cancer patients. The aim of the Medipolis Business is to contribute to people's well-being, improved quality of life, and happiness. For further information, visit . Inquiries: SHIN NIPPON BIOMEDICAL LABORATORIES, LTD. IR & Corporate Communications ([email protected])

前瞻性聲明這份新聞稿以及與該新聞稿有關的任何材料可能包含有關SNBL未來業務、未來地位和業績的前瞻性聲明、信仰或意見,包括SNBL的估計、預測、目標和計劃。毫無限制,前瞻性聲明經常包括以下詞語:“目標”、“計劃”、“相信”、“希望”、“繼續”、“期望”、“瞄準”、“意圖”、“確保”、“將”、“可能”、“應該”、“會”、“盼望”、“估計”、“項目”或類似的表達方式或其否定方式。這些前瞻性聲明是基於許多重要因素的假設,包括以下因素,這些因素可能導致前瞻性聲明表達或暗示的實際結果與前瞻性聲明所表達或暗示的結果不同:圍繞SNBL業務的經濟環境,包括日本和美國的一般經濟狀況;競爭壓力和發展;適用法律和法規的變化;新產品開發中固有的挑戰,包括臨床成功的不確定性以及監管機構的決策及其時機上的不確定性;新產品和現有產品的商業成功的不確定性;利率和貨幣匯率波動;產品候選人的安全性或有效性引起的索賠或關注;衛生危機(如新冠疫情)對SNBL及其客戶和供應商(包括SNBL業務所在國的外國政府)或其業務的其他方面的影響;與所收購的公司進行後併購整合的時間和影響;能夠清除不屬於SNBL業務核心的資產以及任何此類出售的時間;以及SNBL最近的證券報告("YukaShoken Houkokusho")和SNBL在金融服務機構提交的其他報告中確定的其他因素,這些報告可在SNBL的網站上獲得:或在SNBL不承諾更新本新聞稿中包含的任何前瞻性聲明或其它它可能做出的任何其它前瞻性聲明,除非法律或相關證券交易所規則要求。過去的表現並不是未來業績的指標,SNBL在本新聞稿中的結果或聲明可能並不具有,也不是SNBL未來結果的估計、預測、保證或預測。

Cautionary Note on Forward-Looking Statements

前瞻性聲明的警示說明

Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding SNBL's future business, future position and results of operations, including estimates, forecasts, targets and plans for SNBL. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could" "anticipates", "estimates", "projects" or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding SNBL's business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of product candidates; the impact of health crises such as the coronavirus pandemic on SNBL and its clients and suppliers, including foreign governments in countries in which SNBL operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to SNBL's operations and the timing of any such divestment(s); and other factors identified in SNBL's most recent securities report ("YukaShoken Houkokusho") and SNBL's other reports filed with the Financial Services Agency, available on SNBL's website at: or at SNBL does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or related stock exchange rule. Past performance is not an indicator of future results and the results or statements of SNBL in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of SNBL's future results.

醫療信息這份新聞稿包含有關可能不在所有國家可用、可能在不同商標下、用於不同適應症、劑量或不同強度的產品候選人的信息。此處所述內容不應被視爲任何處方藥品(包括正在開發中的藥品)的招募、促銷或廣告。

Medical information

Satsuma Pharmaceuticals, Inc.

This press release contains information about product candidates that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

本新聞稿包含有關某些產品候選藥物的信息,這些藥物可能不在所有國家/地區上市,或因所標示適應症不同、劑量或強度不同而以不同的商標名出售。本文不應視爲招攬、推廣或宣傳包括正在開發中的任何處方藥在內的任何藥品。

Inquiries:
Satsuma Pharmaceuticals, Inc.
E-mail: [email protected]
Website:

查詢:

電郵:[email protected]
網站:

SOURCE Satsuma Pharmaceuticals, Inc.

來源:Satsuma藥品公司。

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。
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