Atzumi (dihydroergotamine) / Shin Nippon Biomedical Labs - LARVOL DELTA

DHE plasma concentration and clinical response relationship—An in-office PK-PD study (AHS 2025) - P3 | "STS101 was well absorbed during migraine attacks. DHE plasma Cmax is a strong predictor for pain relief at 2 h after dosing with higher Cmax resulting in higher responder proportions. More severe baseline pain required higher DHE plasma concentrations to induce pain relief."

Clinical • PK/PD data • CNS Disorders • Migraine • Pain

STS101 (dihydroergotamine nasal powder) shows benefit on the resolution of cardinal migraine symptoms photophobia, phonophobia, and nausea: Results from the long-term phase 3 open-label ASCEND study (AHS 2025) - P3 | "The results of the ASCEND study show that, similar to its effects on migraine headache pain and most bothersome headache-associated symptom, STS101 showed rapid and sustained resolution of each of the cardinal migraine symptoms of photophobia, phonophobia, and nausea."

Clinical • P3 data • CNS Disorders • Migraine • Pain

STS101 use reduces migraine frequency over time (AHS 2025) - P3 | "In subjects who used STS101 over 12 months, significant reductions in treated migraine frequency were observed, especially in those who treated 5 or more attacks in month 1. This longer preventive benefit of DHE has been discussed before and may be related to its effects on multiple receptors involved in migraine pathophysiology (Tepper et al., Cephalalgia Reports 2024)."

CNS Disorders • Migraine • Pain

Strong CYP3A4 inhibitor itraconazole does not cause clinically relevant interactions with STS101 (nasal dihydroergotamine powder) (AHS 2025) - "This Phase 1 study was conducted to evaluate the PK, safety, and tolerability of single doses of 5.2 mg STS101, with and without concomitant dosing of the strong CYP3A4 inhibitor, itraconazole. The results from this study showed that DHE plasma Cmax and AUCinf were increased by approximately 14% and 19%, respectively when STS101 was administered with itraconazole. These increases were not associated with any clinical sequelae, and STS101 was well tolerated by healthy subjects when taken alone and when co-administered with itraconazole."

Clinical • CNS Disorders

The Ongoing Expansion of the Medically Important Scorpions in Southern South America. (PubMed, Ecohealth) - "We present their current suitable areas and the potential future distribution up to 2070...We conclude that, besides synanthropic capabilities, parthenogenesis is the main factor favoring the expansion of some of these species. We also conclude that interactions between invasive Tityus species may hinder their expansion process due to potential competition or exclusion mechanisms."

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Empowering Indonesia's energy transition planning through long-term energy system modelling: A technoeconomic dataset. (PubMed, Data Brief) - "The dataset encompasses historical and projected data from 2010 to 2070 on key aspects such as electricity demand by sector, electricity generation, installed capacity, capacity factors, costs of energy technologies, and renewable energy potentials for solar, wind, hydro, and geothermal power. The data has been collated from Indonesian government reports, international agencies, and academic literature and harmonised using documented assumptions. While Indonesia-specific, this dataset could serve as a template for developing similar energy datasets in other countries, which may face similar challenges in developing energy transition planning."

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Distribution modelling and future prediction of a threatened species - Heracleum candicans Wall. ex DC.; Within the framework of biotic and abiotic interactions. (PubMed, J Environ Manage) - "The suitable habitat of the plant is expected to show contrasting range changes from 2040 to 2070 under both SSP126 and SSP370 scenarios. By the year 2100, the range of suitable habitat is expected to expand under optimistic, and to shrink in a pessimistic scenarios, SSP126 and SSP370, respectively. The predictive modelling approach could be beneficial for assessing the conservation importance and devising the future management strategies and policies for this and number of other endemic and threatened species, especially the medicinal plants."

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Demand starter data kit: Selected socio-economic and technical energy system demand modelling data for all 47 counties in Kenya. (PubMed, Data Brief) - "As a demonstration, these data were used to calibrate a demand model for Kilifi County using the Model for the Analysis of Energy Demand (MAED) for a baseline scenario from 2019 to 2070. The assumptions used and results gained are illustrated in the appendix of the article as a demonstration of what can be achieved through application of this dataset."

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Transitioning to healthy and sustainable diets has higher environmental and affordability trade-offs for emerging and developing economies. (PubMed, Nat Commun) - "In this study, we project changes in water use, dietary quality, and food affordability under four dietary scenarios (including Mediterranean diet, the EAT-Lancet diet, the Healthy US-Style diet, and Vegetarian diet), assessing the potential implications at the country level from 2020 to 2070...However, in the initial phases, increased food demand escalated water use and worsened food affordability, especially in emerging and developing economies, with the maximum average deterioration being 2.62% and 13.06%, respectively. These highlight the need for long-term planning and financial support to ensure successful global transitions."

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Satsuma Pharmaceuticals Announces U.S. FDA Approval for Atzumi (Dihydroergotamine) Nasal Powder for the Acute Treatment of Migraine (PRNewswire) - "Satsuma Pharmaceuticals...and its corporate parent, Shin Nippon Biomedical Laboratories...announced that the U.S. Food and Drug Administration (FDA) has approved a 505(b)(2) New Drug Application (NDA) for Atzumi (dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine with or without aura in adults. Atzumi was previously known as STS101....The FDA approval for Atzumi is based on two clinical studies (Phase 1 PK trial and ASCEND Phase 3 open-label, long-term safety trial), which demonstrated fast absorption, rapid achievement of high DHE plasma concentrations, and sustained DHE plasma levels over time as well as safety and tolerability in subjects with migraine."

FDA approval • Migraine • Pain

How Long Will You Be a Widow? Determinants, Trends, and Income Gradient in Widowhood Duration. (PubMed, Demography) - "Using French life tables from 1962 to 2070 and simulations based on the Gompertz law and a bivariate Gaussian copula, we assess each determinant's relative influence...Despite converging gender life expectancies, our projections suggest that widowhood duration will remain high until 2070, at 9.2 years for females and 6.2 years for males. Notably, we identify a negative gradient in widowhood duration along the standard-of-living distribution."

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Predicted impact of HPV vaccination and primary HPV screening on precancer treatment rates and adverse pregnancy outcomes in Australia 2010-2070: Modelling in a high income, high vaccination coverage country with HPV-based cervical screening. (PubMed, Vaccine) - "This analysis demonstrates that the benefits of HPV vaccination programs extend beyond prevention of HPV-related disease. HPV vaccination will reduce PTBs and LBW infants, with a further reduction with future twice-lifetime screening for HPV9 cohorts."

Adverse events • Journal • Cervical Cancer • Human Papillomavirus Infection • Infectious Disease • Obstetrics • Oncology

COMPRESSED VR EXPOSURE THERAPY HABITUATES PTSD SYMPTOMS IN A CRITICAL ILLNESS SURVIVOR (SCCM 2025) - "Her physical activity IPAQ scores improved from 1130 to 2070 but declined to 546 at 3 months after a rheumatoid disease diagnosis...Her outcomes suggest C-VRET may be useful for habituating trauma symptoms in adult critical illness survivors. Further testing with a large, diverse sample is needed."

Cardiovascular • CNS Disorders • Congestive Heart Failure • Depression • Heart Failure • Immunology • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry

Development of national post-fire restoration system to assess net GHG impacts and salvage biomass availability. (PubMed, MethodsX) - "For 2024 to 2070, we assessed the changes in ecosystem carbon, emissions from harvested wood products, and substitution benefits from avoided emissions-intensive materials, relative to a forward-looking baseline. Our prototype system provides a comprehensive framework, configuration files, links to datasets to quantify the net GHG of post-fire restoration, and sample results for validation.•Developed spatially explicit forest carbon modeling system for all of Canada's forests.•Assessed the net GHG reduction from post-fire restoration.•Used system approach to consider forests, wood products and substitution benefits."

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Development and Validation of a Literature Screening Tool: Few-Shot Learning Approach in Systematic Reviews. (PubMed, J Med Internet Res) - "Our FSL framework demonstrates the potential for reducing workload in SR screening by over 50%. However, the model did not achieve 100% recall at this threshold, highlighting the potential for omitting eligible studies. Future work should focus on developing a web application to implement the FSL framework, making it accessible to researchers."

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Relationship of dihydroergotamine pharmacokinetics, clinical efficacy, and nausea-A narrative review. (PubMed, Headache) - "The maximum concentration and AUC over the first 30 min following DHE administration were associated with increasing rates of 2hPR and a Cmax below ~2500 pg/mL was associated with low incidences of nausea. We suggest that this may be an optimal profile for a DHE delivery form. Further research to test this hypothesis is warranted."

Journal • PK/PD data • Review • CNS Disorders • Migraine • Pain

Satsuma Pharmaceuticals and SNBL Receive FDA Acceptance of NDA Resubmission of STS101 for the Acute Treatment of Migraine With or Without Aura (PRNewswire) - "Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company, and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395), are pleased to announce that the U.S. Food and Drug Administration (FDA) has accepted for review a resubmission to original new drug application (NDA) for the investigational product STS101 (dihydroergotamine nasal powder) for the acute treatment of migraine with or without aura as a complete response to their January 2024 action letter. The Prescription Drug User Fee Act (PDUFA) date is set as April 30, 2025."

FDA filing • PDUFA • CNS Disorders • Migraine

Spatial model of groundwater contamination risks from pit-latrines in a low-income country. (PubMed, Water Res) - "National survey data of over 100,000 water-points and 260,000 pit-latrines in Malawi was used to generate a novel, high-resolution model of pit-latrines from 2020 to 2070 under five population scenarios...The model predicts 8.2 mega-tonnes of faecal nitrogen will be disposed of into subsequently abandoned pit-latrines between 2020 and 2070. Change is necessary to prevent SDG6's push for sanitation undermining its goal of clean water."

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The Impact of Dynamic Mortality on the Cost-Effectiveness of Axicabtagene Ciloleucel Versus Standard of Care As Second-Line Therapy in Patients With Large B-Cell Lymphoma in France (ISPOR-EU 2024) - P3 | "General population mortality from INSEE was simulated in two ways: 1) a static approach where age- and sex-specific mortality data from a single year (2020) was used; and 2) a dynamic approach where year-specific projected mortality for the years 2021 to 2070 was used. Compared to the static approach, using dynamic background mortality resulted in a meaningful reduction in the ICER for axi-cel for 2L LBCL in France. The dynamic approach to modelling should be considered appropriate for French HTA submissions to ensure the impacts of future improvements in health are reflected in estimates of cost-effectiveness."

Clinical • Cost effectiveness • HEOR • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

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

FDA filing • CNS Disorders • Migraine • Pain

Satsuma Pharmaceuticals and SNBL Announce Publication of STS101 (Dihydroergotamine Nasal Powder) Pivotal Phase 3 ASCEND Study in CNS Drugs (PRNewswire) - P3 | N=482 | ASCEND (NCT04406649) | Sponsor: Satsuma Pharmaceuticals, Inc | "Study shows the repeated long-term, as-needed use of STS101 for the acute treatment of a migraine attack demonstrated a favorable safety profile and 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....Satsuma Pharmaceuticals, Inc...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."

P3 data • CNS Disorders • Migraine • Pain

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. (PubMed, CNS Drugs) - P3 | "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."

Journal • P3 data • Cardiovascular • CNS Disorders • Migraine • Pain • Vascular Neurology

Preference of home delivery of oral PrEP versus clinic pick-up among postpartum South African women (HIVR4P 2024) - "Choices regarding HIV test type; n=169, self-tests:101 (60%) and 68 (40%) rapid clinic tests. Early results demonstrate home delivery of PrEP was often selected among postpartum women. These preferences, along with positive associations between home delivery and reported PrEP adherence suggest it may be a viable option for differentiated PrEP service delivery among this key population."

Clinical • Late-breaking abstract • Human Immunodeficiency Virus • Infectious Disease

Rising Obesity-Associated Mortality in Men: Exploration of Gender Disparity from the Global Burden of Disease Study, 1990-2019. (PubMed, J Gen Intern Med) - "Overweight/obesity-related morbidity and mortality are higher among male sex. Identifying differences in pathogenesis, complications and treatment response is crucial to develop targeted interventions and equitable public health policies to combat this global burden."

HEOR • Journal • Genetic Disorders • Obesity

Decomposing high uncertainty in greenhouse gas mitigation pathways in emerging regions: An approach to evaluate risks toward carbon neutrality. (PubMed, Sci Total Environ) - "This uncertainty results in a cumulative projection error of 2.1 billion tons of CO2e from 2020 to 2070...In our uncertainty flow analysis, the energy transformation sector is identified as the principal contributor to total uncertainty, driven significantly by economic and energy-related factors. These results underscore the critical need for policymakers in emerging regions to incorporate uncertainty decomposition analysis into their strategic planning to mitigate risks in GHG reduction efforts."

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