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Accepted Abstracts
Title: Interim Analysis of Subject Impression Data for STS101 From the Phase 3 Open-Label ASCEND Study
Session: P13: Headache: Therapeutics 1
Topic: Headache
Program #: P13.003
Author(s):
Summary: This abstact describes results from Satsuma's Phase 3 ASCEND safety study of STS101. Patient global impression, ease-of-use impression, patient likelihood of use, and comparison of study medication with previously used migraine medication were collected at 3-,6-, and 12-month timepoints and analyzed in the modified intent-to-treat population. All questions were assessed using a 5-point verbal Likert scale.
Conclusion: Subject impression data through 12 months suggest that STS101 was perceived very favorably by subjects on multiple measures, including in comparison to their usual migraine medications.
Title: Interim Analysis of Long-Term Safety and Tolerability Data of STS101 From the Phase 3 Open-Label ASCEND Study
Session: P13: Headache: Therapeutics 1
Topic: Headache
Program #: P13.004
Author(s):
Summary: This abstact describes results from an interim safety analysis of Satsuma's Phase 3 ASCEND safety study of STS101. This interim safety analysis included those participants who exclusively used the STS101, incorporating the second-generation nasal delivery device planned for commercialization. Safety evaluations included treatment-emergent adverse event (TEAE) assessments, physical exams, vital signs, nasal exams, electrocardiograms, and lab tests.
Conclusion: The results of the ASCEND study show that STS101 was well tolerated when used long-term for the acute treatment of migraine attacks.
Title: Interim Analysis of STS101 Nasal Safety Data From the Phase 3 Open-Label ASCEND Migraine Study
Session: P13: Headache: Therapeutics 1
Topic: Headache
Program #: P13.006
Author(s): Egilius L.H. Spierings, MD, PhD,
Summary: This abstact describes results from an interim analysis of Satsuma's Phase 3 ASCEND safety study of STS101. This interim analysis included participants exclusively using the STS101 incorporating the second-generation nasal delivery device planned for commercialization. Nasal safety assessments included nasal treatment-emergent adverse events (TEAEs), subjective assessments of nasal irritation, and a smell test (SIT). Objective nasal assessments were done by trained study personnel on a 4-point severity scale to document nasal erythema, edema, rhinorrhea, bleeding, and nasal mucosa ulcerations.
Conclusion: Nasal safety data from 5,571 treated attacks demonstrate the safety and tolerability of STS101 for the acute treatment of migraine.
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