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Abstract Details

Pharmacokinetic Comparison of STS101, an Intranasal Dry Powder Formulation of Dihydroergotamine, with Other Intranasal, Injectable and Oral Inhaled DHE Formulations
Headache
P14 - Poster Session 14 (8:00 AM-9:00 AM)
7-008
To perform a literature review to compare pharmacokinetic (PK) parameters for several formulations of dihydroergotamine mesylate (DHE) including intravenous (IV), intramuscular (IM), intranasal liquid sprays, orally inhaled, and intranasal dry powder
DHE has been used since 1946 for the acute treatment of migraine, but the approved DHE products, D.H.E.45® (administered IV and IM) and Migranal® (liquid nasal spray) are inconvenient or have an inconsistent response.  Newer development-stage products may provide enhanced PK, improved clinical efficacy, and more patient-friendly administration.
A literature search was performed to compare PK results of several formulations of DHE including the approved products Migranal and D.H.E.45 and the development-stage products INP104 (liquid nasal spray), MAP0004 (orally inhaled), and STS101 (nasal powder). 
STS101 achieved rapid and sustained high drug exposure with low variability.  STS101 had a higher Cmax than Migranal and INP104 and approached that of MAP0004.  The AUC0-2hr and AUC0-inf were ≥2-fold higher for STS101 compared to Migranal, INP104, and MAP0004.  STS101 achieved higher cumulative drug exposure than Migranal, INP104, and MAP0004.  MAP0004 had the fastest time to an effective plasma concentration, while STS101 had the largest total time above the effective plasma concentration compared to MAP0004, INP104, and Migranal.  Dose-normalized plasma concentrations for Migranal were similar across historical studies and the STS101 Phase 1 study, but were lower in the INP104 Phase 1 study.  The coefficient of variation (%CV) for Cmax, AUC0-2hr, and AUC0-inf were lower with STS101 versus Migranal and INP104 and were similar to MAP0004.
The STS101 PK profile predicts that the acute migraine treatment goals should be achieved. Lower PK variability may lead to more consistent and reliable clinical performance. A large Phase 3 efficacy study with STS101 is ongoing to evaluate the product as an acute treatment for migraine (NCT 03901482). 
Authors/Disclosures
Shannon Strom
PRESENTER 		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.
John Kollins No disclosure on file
Detlef Albrecht Detlef Albrecht has received personal compensation for serving as an employee of Satsuma. Detlef Albrecht has stock in Satsuma.