Efficacy
Benefits of DHE and Precision Olfactory Delivery (POD®) technology1,2
In 4 randomized, double-blind, placebo-controlled studies (N=605) of a traditional dihydroergotamine mesylate (DHE) nasal spray product, 30% to 61% of patients had mild or no pain at 2 hours1
Trudhesa™ with advanced POD technology achieved intravenous (IV)-like DHE plasma concentrations after 30 minutes2*
Trudhesa demonstrated rapid, sustained, consistent relief, with no dosing window2,3*
*Based on a phase 3, open-label safety study evaluating exploratory efficacy outcomes and post hoc analyses.
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The clinical efficacy studies of a traditional DHE nasal spray product1
A traditional DHE nasal spray product was evaluated in 4 randomized, double-blind, placebo-controlled studies.1
Percentage of patients who reported mild or no pain† following a single treatment1
N=105
N=98 23%
28%
N=103
N=102 33%
35%
N=103
N=102 20%
22%
N=103
N=102 20%
30%
†Headache response was defined as a reduction in headache severity to mild or no pain. Headache response was based on pain intensity as
interpreted by the patient using a 4-point pain intensity scale. Patients treated a moderate to severe migraine headache with a single dose of study
medication and assessed pain severity over the 24 hours following treatment. Headache response was determined 0.5, 1, 2, 3, and 4 hours after dosing.
Although rescue medication was allowed in all 4 studies, patients were instructed not to use it during the 4-hour observation period.1
‡P<.001; §P<.01.1
Results from the Trudhesa comparative bioavailability study
Trudhesa achieved an absolute DHE bioavailability of 59% vs traditional DHE nasal spray of 15%.2
Rapid and sustained IV-like DHE plasma concentrations with no initial Cmax spike2
Trudhesa achieved plasma concentrations comparable to IV DHE (1.0 mg) and Cmax within 30 minutes without the initial Cmax spike of IV DHE, and sustained levels through 48 hours.4
DHE bioavailability comparison
In a crossover study, Trudhesa provided approximately 4 times the maximum plasma concentration of traditional DHE spray.4
Results from the Trudhesa safety study
With Trudhesa, patients can achieve rapid, sustained, consistent relief even when taken late into an attack.2,3,||
4515 migraine attacks were treated with Trudhesa in the 24-week full safety set population (N=354).2
||Based on exploratory end points and their post hoc analyses of patient-reported efficacy data.2
Rapid pain relief delivered
Pain Relief Postdose
Ad hoc analysis of first migraine attack treated with Trudhesa2
Study patients using their best usual care reported a 30% rate of response at 2 hours.3
Sustained pain freedom delivered
Sustained pain freedom is defined as the percentage of patients who self-reported no other headache at 24 and 48 hours post-Trudhesa administration.
¶Only subjects with non-missing values were included for these exploratory end points.
Of the 4257 migraine attacks treated during the 24-week study, where Trudhesa was used first,
DID NOT REQUIRE
RESCUE MEDICATION USE3#
#Data are self-reported. Excludes migraine attacks that started at baseline and ended in Weeks 1-24 with acute medication is in both periods. These analyses were exploratory in nature and no statistics were done.3
Consistent pain freedom delivered
Measuring response at 2 hours for patients with ≥4 migraine attacks treated with Trudhesa over 12 weeks6
High Levels of Within-Patient Consistency6
No limited dosing window
Patients reported pain freedom despite delayed administration of Trudhesa2,3
Patient-reported results**
As part of the safety study, patients kept a daily e-diary and completed questionnaires about Trudhesa as compared to their best usual care.2
Best usual care = optimal migraine medications established by the patient or healthcare professional. This comprised (sometimes more than one of) the following: acetaminophen, non-steroidal anti-inflammatory drug (NSAID), triptan, combination analgesic, opioid, barbiturate, or ergot.2,7
**Based on results from a poststudy questionnaire, which asked 354 people to rate their experience with Trudhesa against their best usual care, which consisted of their optimal migraine medications established by the patient or healthcare professional. Results were patient-reported and not validated.2,7
References: 1. Trudhesa. Prescribing information. Impel NeuroPharma; 2021. 2. Smith TR, Winner P, Aurora SK, Jeleva M, Hocevar-Trnka J, Shrewsbury SB. STOP 301: a phase 3, open-label study of safety, tolerability, and exploratory efficacy of INP104, Precision Olfactory Delivery (POD®) of dihydroergotamine mesylate, over 24/52 weeks in acute treatment of migraine attacks in adult patients [published online ahead of print, 2021 Aug 7]. Headache. 2021;10.1111/head.14184. doi:10.1111/head.14184. 3. Data on File. Impel NeuroPharma. 2020. 4. Shrewsbury SB, Jeleva M, Satterly KH, Lickliter J, Hoekman J. STOP 101: a phase 1, randomized, open-label, comparative bioavailability study of INP104, dihydroergotamine mesylate (DHE) administered intranasally by a I123 Precision Olfactory Delivery (POD®) Device, in healthy adult subjects. Headache. 2019;59(3):394-409. 5. Tepper SJ, Ailani J, Shrewsbury SB, Aurora SK. Recurrence rates for INP104 for the acute treatment of migraine: results from the phase 3 STOP 301 study. Poster presented at: American Headache Society Virtual Annual Scientific Meeting, June 3-6, 2021. 6. Lipton RB, Nye BL, Hirman J, Shrewsbury SB, Aurora SK. Treatment consistency across multiple migraine attacks: results from the phase 3 open-label STOP 301 study. Poster presented at: American Headache Society Virtual Annual Scientific Meeting, June 3-6, 2021. 7. Shrewsbury SB, Joekman J, Jeleva M. Patient acceptability of a novel upper nasal delivery system for dihydroergotamine mesylate using the Precision Olfactory Delivery (POD®) device – results from the open-label STOP 301 trial. Poster presented at: American Headache Society Virtual Annual Scientific Meeting, June 3-6, 2021.