Last update 11 Nov 2024

Dihydroergotamine Mesylate

Last update 11 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(2R,4R,7R)-N-[(1S,2S,4R,7S)-7-benzyl-2-hydroxy-4-methyl-5,8-dioxo-3-oxa-6,9-diazatricyclo[7.3.0.02,6]dodecan-4-yl]-6-methyl-6,11-diazatetracyclo[7.6.1.02,7.012,16]hexadeca-1(16),9,12,14-tetraene-4-carboxamide, 5'-benzyl-12'-hydroxy-2'-methyl-3',6',18-trioxo-9,10-dihydroergotaman, 9,10-dihydro-12'-hydroxy-2'-methyl-5'-(phenylmethyl)ergotoman-3',6',18-trione

+ [23]

Target

5-HT1D receptor

Mechanism

5-HT1D receptor agonists(Serotonin 1d (5-HT1d) receptor agonists)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Cluster HeadacheMigraine DisordersAcute migraine+ [2]

Inactive Indication-

Originator Organization

Bausch Health Cos., Inc.

Active Organization

Satsuma Pharmaceuticals, Inc.Bausch Health US LLC

Ipi Legacy Liquidation Co.

Inactive Organization

Pulmatrix, Inc.

Drug Highest PhaseApproved

First Approval Date

US (12 Apr 1946),

Cluster HeadacheMigraine Disorders

Regulation-

Structure

Molecular FormulaC34H41N5O8S

InChIKeyADYPXRFPBQGGAH-UMYZUSPBSA-N

CAS Registry6190-39-2

Clinical Trials associated with Dihydroergotamine Mesylate

ACTRN12623001201662 / CompletedPhase 1

A Phase 1, Single Center, Open-Label Study to Evaluate the Pharmacokinetics, Bioavailability, Dose Proportionality, Safety, and Tolerability of Single Ascending Doses of Dihydroergotamine Mesylate (Zephyr) Inhalation Powder, and Dihydroergotamine Mesylate Intravenous, in Healthy Adult Subjects.

Start Date08 Jan 2024

Sponsor / Collaborator-

NCT06319118 / Active, not recruitingNot ApplicableIIT

A Clinical Study of Dihydroergotine Mesylate Extended-release Tablets for the Treatment of Drooling in Parkinson's Disease.

Objective: To evaluate the efficacy and safety of dihydroergotine mesylate extended-release tablets for salivation in Parkinson's disease Study content: Using a randomized, double-blind, placebo-controlled study design, 120 patients with Parkinson's disease and cognitive impairment were enrolled, and the treatment was followed up for 12 weeks: dihydroergotine mesylate sustained-release tablets + conventional treatment (treatment group patients, 80 cases), placebo + conventional treatment (control group patients, 40 cases), and the main indicators were observed: the improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was observed, and the secondary indicators were observed: the effect of dihydroergotine mesylate sustained-release tablets on the cognitive function of PD patients was observed.
Expected results: The improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was significantly different from that of the placebo control group. The dihydroergotine mesylate sustained-release tablet group had a significant effect on the cognitive function of PD patients.

Start Date01 Oct 2023

Sponsor / Collaborator

Second Affiliated Hospital of Soochow University

NCT06035913 / Enrolling by invitationNot ApplicableIIT

Doctor of Medicine, Chief Physician, Associate Professor, Master Supervisor, Administrative Deputy Director of Neurology.

Parkinson's disease is the second most common neurodegenerative disease after Alzheimer's disease, the incidence of population over 60 years old in China is 1.37%, Parkinson's disease is often accompanied by various non-motor symptoms, such as salivation. Salivation can occur at any time in Parkinson's disease, with an incidence of 32% to 74%, often leading to social embarrassment, skin infections, bad breath, aspiration pneumonia, etc. This not only reduces the quality of life of patients, but also increases the burden on caregivers. Salivation can improve symptoms with botulinum toxin injections, medications, and non-drug treatments. Dihydroergot mesylate has been shown to be effective in the treatment of salivation in patients with Parkinson's disease, and this study will further observe the medium- to long-term efficacy of the drug on salivation symptoms.

Start Date01 Sep 2023

Sponsor / Collaborator

Jiangsu Provincial People's Hospital

100 Clinical Results associated with Dihydroergotamine Mesylate

100 Translational Medicine associated with Dihydroergotamine Mesylate

100 Patents (Medical) associated with Dihydroergotamine Mesylate

2,076

Literatures (Medical) associated with Dihydroergotamine Mesylate

01 Jan 2025·JOURNAL OF COLLOID AND INTERFACE SCIENCE

Low blue-hazard white-light emission based on color-tunable triplet-triplet annihilation upconversion

Article

Author: Wan, Shigang ; Dong, Yuxiang ; Guo, Cheng ; Shi, Yizhong ; Zheng, Daoyuan ; Chen, Shuoran ; Gou, Haodong ; Ye, Changqing

The commonly used artificial light sources, such as fluorescent lamps and white light-emitting diodes, often have a high ratio of blue light emission, which poses potential blue light hazards, especially one of the main culprits leading to eye diseases. Therefore, developing novel white lighting sources with low blue-hazard is highly appreciated. In this work, an air-stable and color-tunable triplet-triplet annihilation upconversion (TTA-UC) mechanism was proposed to realize the low blue-hazard white-light emission. The proposed design was composed of three primary RGB colors from the annihilator (9,10-diphenylanthracene, DPA), the laser excitation source, and the photosensitizer (palladium (II) octaetylporphyrin, PdOEP), respectively. The introduction of oil-in-water (o/w) microemulsion can effectively block the potential oxygen-induced triplet-quenching and benefit high UC efficiency. Moreover, either raising ambient temperatures or adding isobutanol can activate the UC process to yield white-light emission. Notably, the white-light emission with a Commission Internationale de l'Eclairage (CIE) coordinate of (0.33, 0.33) as well as a low ratio of blue emission (14.2 %) was achieved at an ambient temperature of 42 °C. Therefore, the proposed air-stable TTA-UC mechanism can significantly lower the blue-hazard and provide a novel solution for applications in lighting and display.

01 Dec 2024·CNS DRUGS

Long-Term (12-Month) Safety and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine: Data from the Phase 3 Open-Label ASCEND Study

Article

Author: Tepper, Stewart J ; Kirby, Louis ; Strom, Shannon ; Rapoport, Alan M ; Ailani, Jessica ; Albrecht, Detlef

BACKGROUND AND OBJECTIVE:

STS101 is an investigational drug-device combination comprising 5.2 mg dihydroergotamine (DHE) powder (6.0 mg DHE mesylate) in a single-use nasal delivery device for the acute treatment of migraine. The primary objective of the ASCEND trial was to assess long-term safety and tolerability of STS101 in the acute treatment of migraine attacks across 12-18 months, with secondary objectives describing efficacy.

METHODS:

ASCEND was an open-label study of STS101 in adults aged 18-65 years with a ≥ 1 year history of migraine with or without aura, with onset before the age of 50 years and 4-12 migraine attacks/month and < 15 headache days/month in each of the 3 months prior to screening. Exclusion criteria included diagnosis of non-migraine headache, history of cerebrovascular disease, and ≥ 2 cardiovascular risk factors. After establishing eligibility, participants could self-administer STS101 5.2 mg as needed for up to 2 doses within 24 h to treat a single migraine attack and up to 12 doses/month. Safety and tolerability evaluations included physical and nasal examinations, vital signs, laboratory tests, and treatment-emergent adverse event (TEAE) assessments. Participants used an electronic diary to record exploratory efficacy parameters, including intensity of headache pain and associated migraine symptoms (photophobia, phonophobia, and nausea). Participant impression questions were asked at months 3, 6, and 12.

RESULTS:

Of the 6610 migraine attacks treated with a total of 8234 STS101 doses in 344 participants, 945/6610 (14.3%) were associated with a TEAE. Events were predominantly mild or moderate in nature and rarely led to premature study discontinuation (15/344 [4.4%] participants). Treatment was associated with rapid onset of freedom from pain (36.6%, 67.1%, and 85.5% of treated attacks 2, 4, and 24 h post-dose, respectively), freedom from most bothersome symptoms (54.3%, 79.6%, and 91.3%), and headache relief (66.5%, 89.1%, and 94.3%). Most participants rated treatment results as good or very good and ease of use as easy or very easy at all time points (months 3, 6, and 12) and indicated they were likely or very likely to use STS101 again.

CONCLUSIONS:

The repeated long-term, as-needed use of STS101 was well tolerated, demonstrating a favorable safety profile in the acute treatment of migraine attacks in appropriately indicated adults. Exploratory efficacy evaluations indicated beneficial effects, which warrant further evaluation.

TRIAL REGISTRATION:

ClinicalTrials.gov identification NCT04406649.

01 Oct 2024·Journal of Translational Internal Medicine

Inhibition of heterogeneous nuclear ribonucleoproteins A1 and oxidative stress reduces glycolysis via pyruvate kinase M2 in chronic thromboembolic pulmonary hypertension

Article

Author: Liu, Jixiang ; Xie, Wanmu ; Yang, Peiran ; Xu, Shiqing ; Tao, Xincao ; Wang, Chen ; Wan, Jun ; Liu, Lianhua ; Zhai, Zhenguo ; Pang, Wenyi ; Hao, Risheng ; Zhao, Lan ; Zhang, Zhu

Abstract:

Background and Objective:

Chronic thromboembolic pulmonary hypertension (CTEPH) is a lethal complication of pulmonary embolism involving pulmonary artery occlusion and microvascular disease. The glucose metabolism and reactive oxygen species (ROS) production may be perturbed in CTEPH, but the precise mechanisms are unclear. This study investigated glucose metabolism in CTEPH employing pulmonary endarterectomy (PEA)-derived pulmonary artery smooth muscle cells (PASMCs) and characterized the roles of pyruvate kinase M2 (PKM2) and its regulation by heterogeneous nuclear ribonucleoproteins A1 (hnRNPA1) and ROS in CTEPH.

Methods:

PEA tissues and blood samples of CTEPH patients were collected to study the levels of PKM2. Primary PASMCs were isolated from PEA tissues. We used small interfering RNAs to knock down PKM2 and hnRNPAI, and applied antioxidant N-acetylcysteine (NAC) and mito-TEMPO to reduce ROS production. The expression of glucometabolic genes, ROS production, glycolysis rate and proliferative and migratory activities were analyzed in PEA-derived PASMCs.

Results:

PKM2 levels in serum and PEA tissues of CTEPH patients were higher than that of the healthy controls. Compared to the control PASMCs, PEA-derived PASMCs showed increased PKM2 expression and ROS production. The rates of glycolysis, proliferation and migration were increased in PEA-PASMCs and could be mitigated by PKM2 downregulation through hnRNPA1 or ROS inhibition.

Conclusions:

Increased glycolysis and PKM2 expression were found in PEA-PASMCs. Inhibition of hnRNPA1 or ROS corrected the aberrant glycolysis, cell proliferation and migration by downregulating PKM2. Regulation of the hnRNPA1/PKM2 axis represents a potential therapeutic target for the treatment of CTEPH.

144

News (Medical) associated with Dihydroergotamine Mesylate

08 Nov 2024

·www.prnewswire.com

Pulmatrix Announces Third Quarter 2024 Financial Results and Provides Corporate Update

Closed transactions with MannKind Corporation validating the potential value of iSPERSE™ technology Pursuing strategic alternatives to further leverage iSPERSE™ and optimize the potential of PUR3100 Completed PUR1900 wind down activities Cash runway projected into Q4 2026 FRAMINGHAM, Mass., Nov. 8, 2024 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (Nasdaq: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious central nervous system and pulmonary disease using its patented dry powder inhalation iSPERSE™ technology, today announced third quarter financial results for 2024 and provided a corporate update on its clinical assets. Peter Ludlum, Interim Chief Executive Officer of Pulmatrix, commented, "Our focus in the third quarter has been to continue our cost saving measures, complete the wind down activities for the Phase 2b study for PUR1900 and close the transactions with MannKind. Repositioning ourselves as a virtual company has allowed us to improve our balance sheet and continue to focus on strategic alternatives that leverage the potential of PUR3100 and our iSPERSE™ technology." Third Quarter 2024 and Recent Program and Corporate Highlights PUR3100 PUR3100 is an orally inhaled dihydroergotamine (DHE) engineered with iSPERSE™ for the treatment of acute migraine. Pulmatrix is currently exploring financing or partnership arrangements to develop and initiate a potential Phase 2 clinical study for PUR3100. In 2023, Pulmatrix announced the FDA's acceptance of an IND application for PUR3100 and receipt of a "study may proceed" letter to proceed with a Phase 2 study, positioning PUR3100 as Phase 2-ready. The IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100 will be investigated in patients with acute migraine. The planned Phase 2 trial builds on the Phase 1 trial results, which were published in 2023 and presented at the American Headache Society's 65th Annual Meeting in June 2023. In May 2024, Pulmatrix announced a peer-reviewed publication of Phase 1 clinical results in Headache: The Journal of Head and Face Pain. The study showed that PUR3100 achieved peak exposures in the targeted therapeutic range and time to maximum concentration occurred at five minutes after dosing at all dosing levels. The PUR3100 dose groups also showed a lower incidence of nausea and no vomiting compared to observations of nausea and vomiting in the intravenously (IV) administered DHE dose group. PUR1800 PUR1800 is a Narrow Spectrum Kinase Inhibitor, engineered with our iSPERSE™ technology, for the treatment of acute exacerbations in chronic obstructive pulmonary disease (AECOPD). In 2023, Pulmatrix presented complete results from a Phase 1b study of PUR1800 for AECOPD, indicating PUR1800 was safe and well tolerated with no observed safety signals. The topline data, along with the results from chronic toxicology studies, support the continued development of PUR1800 for the treatment of AECOPD and other inflammatory respiratory diseases. Pulmatrix plans to pursue partnership or other alternatives to monetize or advance PUR1800. PUR1900 PUR1900 is the Company's inhaled iSPERSE™ formulation of the antifungal drug itraconazole for indications where an orally inhaled antifungal may provide a therapeutic benefit or fulfill an unmet medical need. In agreement with its partner Cipla, Pulmatrix has stopped patient enrollment for the Phase 2b study of PUR1900. The decision to stop the study was unrelated to any safety concerns. This study had been ongoing since the first quarter of 2023. The Company completed all Phase 2b wind down activities within the third quarter of 2024 as planned. After the study wind down, Pulmatrix will bear no further financial responsibility for the development of PUR1900 and will receive 2% royalties on any potential future net sales by Cipla outside the United States. Within the United States, Pulmatrix and Cipla will seek to monetize PUR1900. iSPERSE™ Technology Pursuant to the Cross License Agreement with MannKind the Company granted (i) an exclusive license for iSPERSE formulations of Clofazimine, (ii) an exclusive license to develop, use, manufacture, market, offer and sell formulations of iSPERSE for the treatment of nontuberculous mycobacteria lung disease in humans, (iii) an exclusive license for iSPERSE formulations of insulin, (iv) a non-exclusive license for iSPERSE for the treatment of endocrine disease in humans, and (v) a non-exclusive license for formulations of iSPERSE for the treatment of interstitial lung diseases (including IPF, PPF and other related lung diseases). As of September 30, 2024, Pulmatrix's patent portfolio related to iSPERSE™ included approximately 147 granted patents, 18 of which are granted U.S. patents, with expiration dates from 2024 to 2037, and approximately 51 additional pending patent applications in the U.S. and other jurisdictions. Third Quarter 2024 Financial Results Revenues decreased approximately $1.4 million to $0.4 million for the three months ended September 30, 2024, compared to $1.8 million for the three months ended September 30, 2023. The decrease is primarily related to decreased revenue under the Cipla Agreement related to fewer reimbursable expenses incurred due to the wind down of the PUR1900 Phase 2b clinical trial, as compared to the corresponding period in the previous year. Research and development expenses decreased approximately $3.2 million to $0.8 million for the three months ended September 30, 2024, compared to $4.0 million for the three months ended September 30, 2023. The decrease was primarily due to less employment and other operating cost following the MannKind cross-license agreement announced in May 2024 (the "MannKind Transaction"), which included a transfer of the Company's leased office and laboratory facilities, as well as less cost incurred on the PUR1900 program, for which the winding down of the Phase 2b clinical trial was completed during the three months ended September 30, 2024. General and administrative expenses increased approximately $0.5 million to $2.2 million for the three months ended September 30, 2024, compared to $1.7 million for the three months ended September 30, 2023. The increase was primarily due to one-time employee separation costs. The Company's total cash and cash equivalents balance as of September 30, 2024, was $10.8 million. The Company anticipates that its cash position, based on operational efficiencies and prioritization of spending, is sufficient to fund its operations into the fourth quarter of 2026. About Pulmatrix, Inc. Pulmatrix is a clinical-stage biopharmaceutical company focused on the development of novel inhaled therapeutic products intended to prevent and treat central nervous system ("CNS"), respiratory and other diseases with important unmet medical needs using its patented iSPERSE™ technology. The Company's proprietary product pipeline includes treatments for CNS disorders such as acute migraine and serious lung diseases such as Chronic Obstructive Pulmonary Disease ("COPD") and allergic bronchopulmonary aspergillosis ("ABPA"). Pulmatrix's product candidates are based on its proprietary engineered dry powder delivery platform, iSPERSE™, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes. About iSPERSE™ Technology Our innovative particle engineering technology creates dry powder, which solves limitations of conventional inhaled technologies and expands the universe of inhalable drug therapies. iSPERSE™ is a proprietary technology that allows a broad range of drugs to be formulated as small, dense, and dispersible particles for highly efficient drug delivery and deep penetration into the lungs. iSPERSE™ can efficiently deliver small molecules, drug combinations, peptides, proteins, and nucleic acids via the respiratory system for the treatment of both respiratory and non-respiratory diseases. For more on the Company's inhaled product candidates please visit: . Forward-Looking Statements Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the federal securities laws. Such forward-looking statements include, but are not limited to, statements of historical fact and may be identified by words such as "anticipates," "assumes," "believes," "can," "could," "estimates," "expects," "forecasts," "guides," "intends," "is confident that", "may," "plans," "seeks," "projects," "targets," and "would," and their opposites and similar expressions are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the Company's ability to conduct its business and raise capital in the future when needed; delays in planned clinical trials; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; the ability to secure and enforce legal rights related to the Company's products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Investor Contact: Timothy McCarthy, CFA 917-679-9282 [email protected] SOURCE Pulmatrix Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1License out/inPhase 2Clinical ResultFinancial Statement

31 Oct 2024

·www.prnewswire.com

Satsuma Pharmaceuticals and SNBL Resubmits the New Drug Application for STS101 (Dihydroergotamine Nasal Powder) for the Acute Treatment of Migraine With or Without Aura

DURHAM, N.C., Oct. 30, 2024 /PRNewswire/ -- Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company, and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395), today announced the resubmission of the new drug application (NDA) for the investigational product STS101 (dihydroergotamine nasal powder) for the acute treatment of migraine with or without aura. The U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) in January 2024 for the original NDA submitted in March 2023. After a Type A meeting to discuss the contents of the CRL, Satsuma and SNBL believe the NDA resubmission addresses all findings in the CRL. In the prior CRL, the FDA noted no concerns related with the clinical trial results, including the safety of STS101, and did not request additional clinical trials. However, the Agency provided additional comments primarily related to formulation (Chemistry, Manufacturing, and Control - CMC). "The resubmission of the STS101 NDA resubmission is a critical step in our mission to bring this unique and new therapy to patients experiencing migraine who often have inadequate treatment options," said Ryoichi Nagata, President and CEO of Satsuma, M.D., Ph.D., FFPM. About Satsuma and 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 is headquartered in Research Triangle Park, North Carolina. For further information, please visit . About SNBL 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]) Cautionary Note on Forward-Looking Statements 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 ("Yuka Shoken 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. Medical information 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. Inquiries: Satsuma Pharmaceuticals, Inc. E-mail: [email protected] Website: SOURCE Satsuma Pharmaceuticals, Inc. 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NDA

08 Oct 2024

·www.biospace.com

Satsuma Pharmaceuticals and SNBL Announce Publication of STS101 (Dihydroergotamine Nasal Powder) Pivotal Phase 3 ASCEND Study in CNS Drugs

Study shows the repeated long-term, as-needed use of STS101 for the acute treatment of a migraine attack demonstrated a favorable safety pro was well tolerated. Exploratory Efficacy Endpoints showed that STS101provided rapid freedom from pain (37% of attacks), and rapid freedom from most bothersome symptoms (54% of attacks) at 2 hours and sustained treatment benefits over 48 hours after dosing. DURHAM, N.C. , Oct. 8, 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 publication the STS101 ASCEND Phase 3 long-term, open-label safety trial in CNS Drugs. STS101 is the only product to combine Satsuma’s proprietary SMART™ (Simple MucoAdhesive Release Technology) with an easy-to-use, easy-to carry nasal delivery device. “We are proud to announce the publication of our pivotal safety data, which further reinforce the potential for STS101 to be a unique, well-tolerated treatment that, subject to approval by the FDA, has the potential to deliver rapid and enduring symptom relief for patients with acute migraine,” said Ryoichi Nagata , President and CEO of Satsuma, M.D., Ph.D., FFPM. “We were particularly pleased to see that a vast majority of patients reported that STS101 was easy to use over the entire duration of the study.” The publication, can be found here, “I am pleased that the data demonstrates that STS101 was safe, well tolerated, and easy for patients to use over the long term. This is exciting and important information for people living with migraine who have experienced inadequate relief with existing therapies and the practitioners who treat them who are in need of new options,” said Stewart Tepper , MD, Vice President of the New England Institute for Neurology and Headache in Stamford, Connecticut . “Even with the introduction of new treatment options in the past few years, there is a critical need for novel non-oral treatment options for patients who are often unable to achieve rapid relief with oral routes of administration.” About the ASCEND Study ASCEND Study was a pivotal Phase 3 open-label study that evaluated the safety, tolerability, exploratory efficacy, and patient acceptability of STS101. The trial was conducted at 54 sites in the United States and enrolled 482 patients who had a documented diagnosis of migraine with or without aura, with 4 to 12 migraine attacks per month in each of the 3 months prior to the study. In the trial, 446 patients received at least one dose of STS101 and used 10,137 doses of STS101 for up to 18 months. In the study, STS101 was well tolerated over up to 18-months of as-needed use, with STS101-related treatment-emergent AEs were reported in 14.3 percent of migraine attacks treated with STS101 device planned for commercialization. Furthermore, there was a low rate of adverse event related discontinuation (7% percent). No new safety signals were observed in this study following STS101 treatment. The study also assessed patient-reported exploratory efficacy. Pain freedom, the most bothersome symptom freedom, and pain relief at 2 hours post-STS101 were self-reported in an eDiary, with two-thirds of patients reporting pain relief at two hours following STS101 administration. Exploratory endpoints included a patient global impression questionnaire (PGI) assessing the patient’s impression of STS101 usability and effectiveness. Most patients reported a positive overall impression of STS101, STS101 was easy to use, and they would use the STS101 if available. About Satsuma and 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 is headquartered in Research Triangle Park, North Carolina . For further information, please visit . About SNBL 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 ( ir@snbl.com ) Cautionary Note on Forward-Looking Statements 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 (“Yuka Shoken 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. Medical information 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. Inquiries: Satsuma Pharmaceuticals, Inc. E-mail: info@satsumarx.com Website: View original content: SOURCE Satsuma Pharmaceuticals, Inc.

Clinical ResultPhase 3

100 Deals associated with Dihydroergotamine Mesylate

External Link

KEGG	Wiki	ATC	Drug Bank
D02211	Dihydroergotamine Mesylate	N02CA01	DB00320

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Cluster Headache	US	Bausch Health US LLC	12 Apr 1946
Migraine Disorders	US	Bausch Health US LLC	12 Apr 1946

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Acute migraine	NDA/BLA	US	Satsuma Pharmaceuticals, Inc.	18 May 2023
Migraine With Aura	Phase 3	US	Satsuma Pharmaceuticals, Inc.	24 Jun 2019
Migraine Without Aura	Phase 3	US	Satsuma Pharmaceuticals, Inc.	24 Jun 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04406649 (ASCEND, Literature) Manual	Phase 3	Migraine Disorders	344	STS101 5.2 mg	lmsirsajdv(mjnvueorzi) = burxusznlb ixzleodtft (nefalundco ) View more	Positive	07 Oct 2024
NCT05351086 (PRNewswire) Manual	Phase 1	Acute migraine	-	PUR3100 with intravenous (IV) placebo	wgyzjylxtj(gskiknvaqx) = gqgzwfjbnb lpmkdoevkr (zpyshmjdry ) View more	Positive	15 May 2024
NCT04940390 (SUMMIT, CTgov)	Phase 3	Migraine With Aura \| Migraine Without Aura	1,591	Placebo	jzzhayfygq(wmdszylkhc) = gbpclrqmjr wwzntopinf (ndtghdmnos, qohahyyzmm - zoyydlaznl) View more	-	24 Jul 2023
NCT04406649 (ASCEND, CTgov)	Phase 3	Migraine With Aura \| Migraine Without Aura	482	STS101	khloooyquc(utbzmogczi) = kxclfjmduh uoyvogmgir (vdadyvjwfd, wcixdnfwvi - mfviprifkb) View more	-	03 Jul 2023
NCT03901482 (EMERGE, CTgov)	Phase 3	Migraine With Aura \| Migraine Without Aura	1,201	Dihydroergotamine (STS101 Low Dose)	peekwaafkm(uvagibynbm) = nzmaygcbtw hqhgruxhaw (ovrirjbfdf, ntzsidapbr - wptxrtffoy) View more	-	29 Jun 2023
NCT03901482 (EMERGE, CTgov)	Phase 3	Migraine With Aura \| Migraine Without Aura	1,201	Dihydroergotamine (STS101 High Dose)	peekwaafkm(uvagibynbm) = nmbvyxuksn hqhgruxhaw (ovrirjbfdf, vujplhumwt - sdjooqwjdl) View more	-	29 Jun 2023
NCT04406649 (ASCEND, AAN2023)	Phase 3	Migraine Disorders	344	STS101 5.2 mg	omkiolosnn(gwpfzmxphd) = 99.5% of subjects had no nasal bleeding/ulceration at 12 months nqqdsqxdgx (nttqzouwwq ) View more	-	25 Apr 2023
NCT04940390 (SUMMIT, GlobeNewswire) Manual	Phase 3	Migraine Disorders	1,591	STS101	lazwcvuwlu(zehnmljrdf): P-Value = 0.1661 View more	Negative	14 Nov 2022
NCT04940390 (SUMMIT, GlobeNewswire) Manual	Phase 3	Migraine Disorders	1,591	Placebo	lazwcvuwlu(zehnmljrdf): P-Value = 0.1661 View more	Negative	14 Nov 2022
NCT04406649 (ASCEND, Corporate Publications) Manual	Phase 3	Migraine Disorders	482	Dihydroergotamine	qhjmmrkwye(thpmwndqfh) = no treatment-related serious adverse events were reported qcqjamdxpt (xruwxgiywl )	Positive	20 Sep 2022
STOP 301 (AAN2022)	Phase 3	Migraine Disorders	354	INP104 (1.45 mg)	ssrekzfgwh(ejqefgzgwo) = mgkfrgxfoj opcubkhngf (pbfzqkqarz ) View more	-	03 May 2022
STOP 301 (AAN2022)	Phase 3	Migraine Disorders	354	INP104 (1.45 mg)	zafncotufc(euugwbylvh) = gqyprpvktr mrocsyqvhs (agpferycwc ) View more	-	03 May 2022

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