Satsuma Pharmaceuticals and SNBL Announce Three Abstracts on STS101 for the Acute Treatment of Migraine to be Presented at the American Headache Society’s 65th Annual Scientific Meeting
15 Junho 2023 - 9:00AM
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 three abstracts describing efficacy and safety results from
the STS101 Phase 3 efficacy trial were selected for presentation at
the American Headache Society’s (AHS) 65th Annual Scientific
Meeting. The 2023 meeting will be held in a hybrid virtual and
in-person format at the JW Marriott in Austin, Texas from Thursday,
June 15 to Sunday, June 18, 2023. Full abstracts are now available
on the AHS website and will be published in the
journal Headache®.
Oral Presentation Details: |
Title: |
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Sustained Efficacy of STS101 DHE Nasal Powder for the Acute
Treatment of Migraine: Results from the Phase3 Double-Blind,
Randomized, Placebo-Controlled SUMMIT Study |
Presenter: |
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Alan Rapoport, MD, Professor of Neurology, David Geffen School
of MedicineUniversity of California Los Angeles (UCLA) |
Date: |
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Saturday, June 17, 2023 |
Time: |
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7:50 AM - 8:00 AM CT (8:50 AM – 9:00 AM ET) |
Location: |
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Lone Star Ballroom D-E |
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Poster
Presentation Details: |
Title: |
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Efficacy of STS101 DHE Nasal Powder for the Acute
Treatment of Difficult to Treat Migraines: Results from the Phase 3
Double-Blind, Randomized, Placebo-Controlled SUMMIT
Study |
Presenter: |
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Jessica Ailani, MD |
Date: |
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Friday, June 16, 2023 |
Time: |
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1:35 PM – 2:50 PM CT (2:35 PM – 3:50 PM ET) |
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Title: |
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Efficacy and Safety of STS101 DHE Nasal Powder for the
Acute Treatment of Migraine: Results from the Phase 3 Double-Blind,
Randomized, Placebo-Controlled SUMMIT Study |
Presenter: |
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Richard B. Lipton, MD |
Date: |
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Saturday, June 17, 2023 |
Time: |
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1:45 PM – 3:09 PM CT (2:45 PM – 4:09 PM ET) |
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
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. 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 Research
Triangle Park, North Carolina. For further information, please
visit
www.satsumarx.com.
About SNBL
Shin Nippon Biomedical Laboratories, Ltd.
(“SNBL”) (TSE:2395) is a listed nonclinical contract research
organization (CRO) that was founded in Kagoshima, Japan, in 1957.
Based on its corporate philosophy of “We are a company that values
the environment, life, and people”, 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 a large tract of land and forests
it owns in Ibusuki-City in Kagoshima prefecture, to promote the
local economy and environmental conservation at the same time
thorough its power generation and hospitality businesses. The aim
of the Medipolis business is to contribute to people’s well-being,
improved quality of life, and happiness. For further information,
visit https://www.snbl.co.jp. Inquiries: SHIN NIPPON BIOMEDICAL
LABORATORIES, LTD. IR & Corporate Communications (E-mail:
ir@snbl.com)
Cautionary Note on 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: https://www.snbl.co.jp/ir/library/
or at https://disclosure.edinet-fsa.go.jp/. 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
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or statements of SNBL in this press release may not be indicative
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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: |
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info@satsumarx.com |
Website: |
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www.satsumarx.com |
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