Hyperacusis

DUBLIN--( BUSINESS WIRE )--The "Migraine Drugs Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2022-2027" report has been added to ResearchAndMarkets.com's offering. The global migraine drugs market size reached US$ 3.9 Billion in 2021. Looking forward, the publisher expects the market to reach US$ 5.4 Billion by 2027, exhibiting a CAGR of 5.57% during 2021-2027. Companies Mentioned Abbott Laboratories Allergan Plc (Abbvie Inc.) Amgen Inc. AstraZeneca Plc Bausch Health Companies Inc. (formerly Valeant Pharmaceuticals) Eisai Co. Ltd. Eli Lilly and Company Endo International Plc GlaxoSmithKline Plc Johnson & Johnson Merck & Co. Novartis AG Pfizer Inc. Sanofi SA Teva Pharmaceutical Industries Limited Keeping in mind the uncertainties of COVID-19, we are continuously tracking and evaluating the direct as well as the indirect influence of the pandemic. These insights are included in the report as a major market contributor. Migraine is a neurological condition that causes unilateral or throbbing pain in the forehead, side of the head or around the eyes. The pain is often accompanied by autonomic symptoms, such as nausea, vomiting, photophobia and phonophobia. Migraine is generally diagnosed by examining the patient's medical history and symptoms, as well as by performing blood tests, and magnetic resonance imaging (MRI) and computerized tomography (CT) scans. At present, over the counter (OTC) medicines and prescribed injections are available to relieve the symptoms and reduce the frequency and severity of migraine attacks. These drugs are either taken regularly or during attacks or exacerbations of chronic pain. A significant rise in the prevalence and diagnosis of migraine represents one of the key factors bolstering the market growth. Apart from this, the improvement in reimbursement policies for migraine medications, along with the escalating demand for precision medicines, is also contributing to the market growth. Furthermore, the growing demand for electrical nerve stimulating devices to treat migraine and the expected approval of new classes of drugs that are in late-stage pipeline and have higher clinical efficacy, such as the introduction of calcitonin gene-related peptide (CGRP) monoclonal antibodies, are also driving the market growth. However, a decline in clinical visits and procedural treatment of migraines due to social distancing norms has impacted the market growth. Key Market Segmentation: The publisher provides an analysis of the key trends in each sub-segment of the global migraine drugs market report, along with forecasts at the global, regional and country level from 2022-2027. Our report has categorized the market based on treatment type, drug type, route of administration and distribution channel. Breakup by Treatment Type: Abortive Treatment Preventive Treatment Breakup by Drug Type: Triptans Ergot Alkaloids NSAIDs Acetylcholine Inhibitors/ Neurotoxins Ditans CGRP mAbs Others Breakup by Route of Administration: Oral Injectable Others Breakup by Distribution Channel: Hospital-Based Pharmacies Retail Pharmacies Others Breakup by Region: North America United States Canada Asia Pacific China Japan India South Korea Australia Indonesia Others Europe Germany France United Kingdom Italy Spain Russia Others Latin America Brazil Mexico Others Middle East and Africa Key Questions Answered in This Report: How has the global migraine drugs market performed so far and how will it perform in the coming years? What has been the impact of COVID-19 on the global migraine drugs market? What are the key regional markets? What is the breakup of the market based on the treatment type? What is the breakup of the market based on the drug type? What is the breakup of the market based on the route of administration? What is the breakup of the market based on the distribution channel? What are the various stages in the value chain of the industry? What are the key driving factors and challenges in the industry? What is the structure of the global migraine drugs market and who are the key players? What is the degree of competition in the industry? For more information about this report visit https://www.researchandmarkets.com/r/54d3a3

STS101 was not statistically superior to placebo at two hours post-administration on the co-primary endpoints of freedom from pain and most bothersome symptom STS101 showed superiority (p<0.001) differences versus placebo on freedom from pain and most bothersome symptom at all timepoints after two hours post-administration (3, 4, 6, 12, 24 and 48 hours), as well as on multiple key secondary endpoints, including pain relief at 2 hours post-administration and all timepoints thereafterSTS101 demonstrated a favorable safety and tolerability profile, consistent with clinical trial experience to dateBased on previous interactions with the FDA, Satsuma believes results from the STS101 Phase 1 PK and ASCEND Phase 3 long-term, open-label safety trials will support NDA filing and approvalCompany does not plan to invest in commercializing STS101 and will actively explore alternatives to maximize value for shareholders, while minimizing cash expendituresEstimated cash and equivalents as of October 31, 2022: $59.4 million Management to host investor call and webcast at 8:30 am EST today SOUTH SAN FRANCISCO, Calif., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today reported topline results from the STS101 SUMMIT Phase 3 efficacy trial. Although topline data showed numerical differences in favor of STS101 5.2 mg versus placebo on the pre-specified co-primary endpoints of freedom from pain and freedom from most bothersome symptom (from among photophobia, phonophobia and nausea) (MBS-free) at two hours post-administration, these differences did not achieve statistical significance (p-value <0.05). STS101 did, however, demonstrate significant effects on both freedom-from-pain and MBS-free endpoints by three hours post-dose and at all subsequent timepoints at which efficacy was assessed (4, 6, 12, 24 and 48 hours). (See Figures 1 and 2 below.) Figure 1: % of subjects Pain Free over time (single dose of STS101; no rescue medications) https://www.globenewswire.com/NewsRoom/AttachmentNg/295eef04-efd1-40b1-8cd3-5b44216aee16 Figure 2: % of subjects free from MBS over time (single dose of STS101; no rescue medications) https://www.globenewswire.com/NewsRoom/AttachmentNg/e9f52ed8-75b6-472c-bc2b-65eaa0a9706a In addition, STS101 was statistically superior to placebo on multiple key secondary endpoints considered clinically relevant and recommended for assessment in acute-treatment-of-migraine efficacy trials by the U.S. Food and Drug Administration (FDA) in its current industry guidance document and/or the International Headache Society’s guidelines for controlled trials:1,2 Proportion of subjects with pain relief at 2 hours post-dose (p=0.0017) and at all timepoints thereafterProportion of subjects requiring rescue medication within 24 hours and 48 hours post-treatment (p<0.0001 and p=0.0001, respectively)Proportion of subjects with 24-hour sustained freedom from pain, i.e., the proportion of subjects who reported no headache pain at 2 hours post-dose who remained free from pain at all timepoints through 24 hours (p=0.0479) Consistent with clinical trial experience to date, STS101 demonstrated a favorable safety and tolerability profile in SUMMIT. The only treatment-emergent adverse event reported by more than 5% of SUMMIT subjects who self-administered STS101 was nasal discomfort, reported by 8.3% of subjects. No treatment-related serious adverse events or cardiovascular events occurred. “We are surprised and disappointed that STS101 did not demonstrate statistically significant superiority over placebo at two-hours post treatment on the SUMMIT study co-primary endpoints,” stated John Kollins, Satsuma’s President and Chief Executive Officer. “However, based on our interactions to date with the FDA, we believe the results from the STS101 Phase 1 pharmacokinetic and ASCEND Phase 3 open-label, long-term safety trials will support the STS101 NDA filing and marketing approval. A large proportion of people with migraine do not achieve sufficient and sustained relief with current treatments, and we believe that in total, the data from the STS101 clinical program, in which more than 1,600 subjects treated more than 8,500 migraine attacks with more than 10,000 doses of STS101, demonstrate that STS101 has a differentiated profile and may address the unmet needs of many patients.” In addition, Satsuma announced that it does not plan to invest in commercializing STS101 and will actively explore alternatives to maximize value for shareholders, while minimizing cash expenditures. As of October 31, 2022 the company had estimated cash and equivalents $59.4 million. Conference Call and Webcast Details Satsuma management will host a conference call and accompanying webcast for investors at 8:30 am EST this morning. Interested participants may register for the call using the following link: https://conferencingportals.com/event/yMGurUMf The call can then be accessed by dialing 888-330-2513 (toll free) or 240-789-2726 (toll) and referencing conference ID 49226-446. The accompanying webcast, which will feature a slide presentation, can be accessed at the following link: https://event.on24.com/wcc/r/4024205/07BAE6AA1EF580725929A36DE3450D67 Participants are asked to dial in approximately ten minutes prior to the start of the call. The webcast slide presentation is also available in the Events and Presentations page of our website: https://investors.satsumarx.com/events About Satsuma Pharmaceuticals and STS101 Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product, STS101, 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 significant benefits versus existing acute treatments for migraine, including the combination of quick and convenient self-administration and other clinical advantages, that current DHE liquid nasal spray products and injectable dosage forms lack. Satsuma’s dry powder DHE formulation has demonstrated fast absorption, rapid achievement of high DHE plasma concentrations which Satsuma believes is necessary for robust efficacy, and sustained DHE plasma levels over time with low dose-to-dose variability. STS101 also now incorporates an improved 2nd-generation nasal delivery device designed to provide more consistent nasal dosing, irrespective of user administration technique. DHE has long been recommended in published migraine treatment guidelines as a first-line acute treatment option for migraine and has significant advantages versus other anti-migraine treatments for many patients. However, disadvantages of current DHE liquid nasal spray and injectable products, including invasive and burdensome administration and/or sub-optimal clinical performance, have limited the widespread use of DHE. Featuring an easy-to-carry and easy-to-use dosage form, STS101 is designed to overcome these shortcomings and provide patients an improved therapeutic solution for acutely treating migraines that consistently delivers robust clinical performance. Satsuma is headquartered in South San Francisco, California with operations in both California and Research Triangle Park, North Carolina. For further information, please visit www.satsumarx.com. Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements concerning the business, operations and financial performance and condition of Satsuma Pharmaceuticals, Inc. (the “Company”), as well as the Company’s plans, objectives and expectations for its business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about the Company’s expectations regarding the potential safety and efficacy of STS101, the potential results of the ASCEND and SUMMIT trials, the timing of data readouts for ongoing clinical trials, the anticipated timing for a potential STS101 NDA submission, the potential for STS101 to be an important and differentiated acute treatment option, and the expected cash runway of the Company. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of STS101; the results of preclinical and clinical studies may not be predictive of future results; and the risk that the COVID-19 worldwide pandemic may negatively impact the Company’s business, operations, clinical trials or ability to raise capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. INVESTOR AND CORPORATE CONTACTS: Corey Davis, PhDLifeSci Advisors, LLC212-915-2577cdavis@lifesciadvisors.com Tom O’Neil, Chief Financial OfficerSatsuma Pharmaceuticals, Inc.tom@satsumarx.com 1 FDA Guidance, Migraine: Developing Drugs for Acute Treatment, February 2018 2 Diener et al., Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth Edition, Cephalalgia, 2019

- More than 1,400 subjects randomized -- Satsuma expects to announce topline SUMMIT trial results in Q4 2022 - SOUTH SAN FRANCISCO, Calif., Aug. 02, 2022 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced completion of subject enrollment in the Company’s ongoing STS101 SUMMIT pivotal Phase 3 efficacy trial, with more than 1,400 subjects randomized. Satsuma expects to announce topline results from the SUMMIT trial in the fourth quarter of 2022. “We are pleased to report completion of subject enrollment in the STS101 SUMMIT Phase 3 efficacy trial, the largest-ever randomized and controlled trial of a DHE product,” stated John Kollins, Satsuma’s President and Chief Executive Officer. “This marks an important milestone in our STS101 development program. We look forward to reporting SUMMIT trial topline results in the fourth quarter of 2022, and, in the interim, to reporting further STS101 development program progress and clinical data, including topline results from our ongoing STS101 ASCEND Phase 3, open-label, long-term safety trial.” STS101 SUMMIT Pivotal Phase 3 Efficacy TrialThe STS101 SUMMIT pivotal Phase 3 efficacy trial is a multi-center, single-dose, randomized, double-blind, placebo-controlled, parallel group study in more than 1,400 subjects with migraine that is being conducted in the United States. The trial is designed in accordance with recommendations contained in the U.S. Food and Drug Administration’s (FDA) current guidance document for industry (Migraine Developing Drugs for Acute Treatment, February 2018) and the International Headache Society’s (IHS) published guidelines for controlled trials of acute treatment of migraine attacks in adults.1 The SUMMIT trial, the largest-ever randomized and controlled trial of a DHE product, provides a basis for STS101 to become the first and only DHE product to demonstrate efficacy in a randomized and controlled trial on co-primary endpoints (freedom from pain and freedom from most bothersome symptom at two hours post-treatment) currently recommended by the FDA and IHS. Based on Satsuma’s communications with the FDA, including a Type B, clinical pre-NDA videoconference meeting held in May 2022, the Company believes the SUMMIT trial, if successful, will support inclusion of differentiating efficacy claims in the STS101 prescribing information, presuming STS101 is approved for marketing. After establishing full eligibility, SUMMIT trial participants are randomized (1:1) to receive either STS101 5.2 mg or matching placebo and instructed to treat their next migraine attack of at least moderate pain severity with the allocated blinded study medication. Following randomization, participants have 56 days in which to treat the qualifying migraine attack. The co-primary endpoints of the SUMMIT trial, to be assessed at two hours after STS101 administration, are freedom from pain and freedom from most bothersome symptom (from among photophobia, phonophobia or nausea). The trial is designed for greater than 99% statistical power for the freedom from pain endpoint and greater than 95% statistical power for the freedom from most bothersome symptom endpoint. In addition, the SUMMIT trial incorporates a number of secondary endpoints and prospective evaluations of the clinical performance of STS101 that could differentiate the clinical profile of STS101. Satsuma expects to report topline results from the SUMMIT trial in the fourth quarter of 2022. For further information regarding the STS101 SUMMIT Phase 3 efficacy trial, see www.ClinicalTrials.gov, identifier NCT04940390: A Randomized, Double-Blind, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine (SUMMIT). About Satsuma Pharmaceuticals and STS101Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product, STS101, 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 significant benefits versus existing acute treatments for migraine, including the combination of quick and convenient self-administration and other clinical advantages, that current DHE liquid nasal spray products and injectable dosage forms lack. Satsuma’s dry powder DHE formulation has demonstrated fast absorption, rapid achievement of high DHE plasma concentrations which Satsuma believes is necessary for early efficacy, and sustained DHE plasma levels over time with low dose-to-dose variability. STS101 also now incorporates an improved 2nd-generation nasal delivery device designed to provide more consistent nasal dosing, irrespective of user administration technique. DHE has long been recommended in published migraine treatment guidelines as a first-line acute treatment option for migraine and has significant advantages versus other anti-migraine treatments for many patients. However, disadvantages of current DHE liquid nasal spray and injectable products, including invasive and burdensome administration and/or sub-optimal clinical performance, have limited the widespread use of DHE. Featuring an easy-to-carry and easy-to-use dosage form, STS101 is designed to overcome these shortcomings and provide patients an improved therapeutic solution for acutely treating migraines that consistently delivers robust clinical performance. Satsuma is headquartered in South San Francisco, California with operations in both California and Research Triangle Park, North Carolina. For further information, please visit www.satsumarx.com. Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements concerning the business, operations and financial performance and condition of Satsuma Pharmaceuticals, Inc. (the “Company”), as well as the Company’s plans, objectives and expectations for its business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about the Company’s expectations regarding the potential safety and efficacy of STS101, the potential results of the ASCEND and SUMMIT trials, the timing of data readouts for ongoing clinical trials, the anticipated timing for a potential STS101 NDA submission, the potential for STS101 to be an important and differentiated acute treatment option, and the expected cash runway of the Company. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of STS101; the results of preclinical and clinical studies may not be predictive of future results; and the risk that the COVID-19 worldwide pandemic may negatively impact the Company’s business, operations, clinical trials or ability to raise capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. This press release discusses STS101, a product candidate that is in clinical development, and which has not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of STS101 for the therapeutic use for which STS101 is being studied. INVESTOR AND CORPORATE CONTACTS: Corey Davis, PhDLifeSci Advisors, LLCcdavis@lifesciadvisors.com Tom O’Neil, Chief Financial OfficerSatsuma Pharmaceuticals, Inc.tom@satsumarx.com 1 Diener et al., Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth Edition, Cephalalgia, 2019