Abstract Details

Title Cardiovascular Safety of STS101, A Novel Investigational DHE Nasal Powder Product: Initial Data from the ASCEND Study

Topic Headache

Presentation(s) P14 - Poster Session 14 (11:45 AM-12:45 PM)

Poster/Presentation
Number 15-006

Objective Evaluation of cardiovascular safety of STS101, a novel investigational dihydroergotamine (DHE) nasal powder, in the acute treatment of migraine attacks in an open-label, 12-month study.

Background The DHE package inserts carry warnings regarding use in patients with cardiovascular (CV) disease or CV risk factors. However, these warnings are based on single case reports, associated with excessive dosage, other risk factors, or use of concomitant medications (Silberstein, 1995) and no formal evaluation of the risks of DHE in patients with CV risk factors has been conducted.

Design/Methods ASCEND is an ongoing, multi-center, open-label, 12-month safety study. Study subjects are allowed to have one CV risk factor and may use up to 2 doses of STS101 5.2 mg within 24 hours and up to 12 doses per month. CV safety evaluations include adverse event assessments, blood pressure, and electrocardiogram (ECG).

Results The safety population included 273 subjects who treated 4247 migraine attacks. The population mean age was 39 ± 11 years, 89% female, and 84% Caucasian. Six cardiovascular adverse events were reported in five subjects (1.8%). Five events were assessed as related to STS101: one event each of moderate tachycardia, and mild increased blood pressure, three events of flushing/hot flashes in 2 subjects (2 mild, one moderate). All events were transient and resolved without treatment or sequelae. One subject had postural orthostatic tachycardia syndrome (unrelated to STS101 and reported as an SAE due to hospitalization). No SAEs related to STS101 occurred. Analyses of blood pressure and ECGs at every study visit did not show clinically significant changes in mean systolic or diastolic blood pressure, heart rate, duration of RR, QRS and QTcF.

Conclusions STS101 was well tolerated and did not show clinically relevant cardiovascular adverse events in subjects with migraine when used long-term and on a PRN basis.

Authors/Disclosures
Detlef Albrecht PRESENTER	Detlef Albrecht has received personal compensation for serving as an employee of Satsuma. Detlef Albrecht has stock in Satsuma.
Alan M. Rapoport, MD, FAAN	Dr. Rapoport has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie, Amgen, Biohaven, Cala Health, Satsuma, Teva Pharmaceutical Industries, Theranica, Xoc and Zosano. Dr. Rapoport has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AbbVie, Amgen, Biohaven, Lundbeck and Teva Pharmaceutical Industries. Dr. Rapoport has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Neurology Reviews.
Shannon Strom	Shannon Strom has received personal compensation for serving as an employee of Satsuma Pharmaceuticals. Shannon Strom has received personal compensation in the range of $0-$499 for serving as a Consultant for Arena Pharmaceuticals. Shannon Strom has stock in Satsuma Pharmaceuticals.

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