Abstract Details

Title Pharmacokinetic Comparison of STS101 (A Novel Investigational DHE Nasal Powder) with Liquid Nasal, Injectable and Oral Inhaled DHE Formulations

Topic Headache

Presentation(s) P13 - Poster Session 13 (8:00 AM-9:00 AM)

Poster/Presentation
Number 15-004

Background DHE has been used since 1946 for the acute treatment of migraine, but the approved DHE products have significant limitations, including requirement for injection, adverse events, and inconsistent response.

Objective To perform a literature review to compare pharmacokinetic (PK) parameters for dihydroergotamine mesylate (DHE) formulations including intravenous (IV), intramuscular (IM), liquid nasal sprays (LNS), orally inhaled, and STS101, an investigational nasal powder.

Design/Methods A literature search was performed to compare PK data of the approved products DHE liquid nasal spray (LNS) 2.0 mg, IM DHE injection, DHE LNS 1.45 mg, and the investigational products MAP0004 (orally inhaled) and STS101.

Results STS101 had a higher C_max than DHE LNS 2.0 mg and DHE LNS 1.45 mg and approached that of MAP0004 and IM DHE. The STS101 AUC_0-2hr and AUC_0-inf were 2-fold greater than DHE LNS 2.0 mg, DHE LNS 1.45 mg, and MAP0004. In two PK studies, STS101 achieved 79% and 83% of the total drug exposure of IM DHE and was comparable to IV DHE. STS101 had low variability similar to MAP0004 and had lower variability than the DHE LNSs.

Conclusions C_maxand early exposure levels may be important for efficacy at 2 hrs. STS101 demonstrated greater PK values and less PK variability compared to the approved DHE LNSs. As compared with MAP0004, STS101 achieved similar C_max, higher AUC at all time points after ~30 minutes and similar PK variability. STS101 showed high sustained plasma concentrations, AUC_0-inf comparable to the IV DHE values, and approached the IM DHE values. STS101’s lower PK variability may lead to more consistent and reliable clinical performance.

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.
Detlef Albrecht	Detlef Albrecht has received personal compensation for serving as an employee of Satsuma. Detlef Albrecht has stock in Satsuma.