Poster presented at the International Headache Congress (IHC) 2019 in Dublin, Ireland. Authors: Kelsey H. Satterly, Stephen B. Shrewsbury, John Hoekman Objective: To compare plasma exposure in the first two hours following administration of INP104 (dihydroergotamine mesylate [DHE] by Precision Olfactory Delivery [POD®]), Migranal® Nasal Spray, D.H.E. 45® (IV) or MAP0004 (oral inhalation)...

Poster presented at the International Headache Congress (IHC) 2019 in Dublin, Ireland. Authors: Sutapa Ray, Stephen Shrewsbury Objective: Ergot use in obstetrics dates back to 1100 BC in China, 370 BC by Hippocrates and 1808 in the US. However, it was not until 1918 that ergotamine was isolated, subsequently modified to DHE and...

Poster presented at International Headache Congress (IHC) 2019 in Dublin, Ireland Authors: Stephen B. Shrewsbury, Maria Jeleva, Jasna Hocevar-Trnka, Meghan Swardstrom Objective: 1) Establish safety and tolerability of repeated INP104 exposure 2) Explore efficacy of INP104 in migraineurs (compared to baseline) 3) Explore INP104 effects on Quality of Life and Healthcare Utilisation...

DHE is effective for acute migraine. The approved label warns of potential cardiovascular effects although the clinical experience of DHE over 70 years of use has been good. Work has shown the high Cmax of IV DHE may account for increased pulmonary arterial systolic pressure through increased adrenergic receptor binding....

Dihydroergotamine mesylate was approved in 1946 for the treatment of migraine and for the next 40 years was available as the most specific, acute anti-migraine therapy until the advent of the Triptans. DHE is still used today, available in multiple formulations and remains a dependable choice for Neurologists and Headache...

Migraine is a common, disabling disorder. IV DHE is an effective abortive therapy; however, the nasal formulation, Migranal®, has poor bioavailability and variable efficacy. We found INP104 (1.45 mg DHE) to have 4X greater systemic exposure than Migranal (2 mg) as a result of delivery technology4. In INP104, the POD...

Poster presented at World Parkinson's Congress 2019 in Kyoto, Japan Authors: Shrewsbury SB, Campbell J, Swardstrom M, Lehn A, Satterly KH, Hoekman J Objective: Impel NeuroPharma has developed the patient-friendly, self or caregiver actuated Precision Olfactory Delivery (IMPEL PODTM) device to achieve consistent upper nasal cavity drug delivery, rapid systemic uptake and higher bioavailability relative to standard nasal sprays. This study with L-dopa for treatment of morning...

A patient-friendly, self or caregiver actuated device to achieve consistent upper nasal space drug delivery, rapid systemic uptake and higher bioavailability than standard nasal sprays. The Quantitative Scoring Scale – Nasal Mucosa (QSS-NM) was developed, at FDA request, as a physician-administered major component of a comprehensive nasal assessment. ...