PRESCRIBING IS HASSLE-FREE, WITH NATIONWIDE
AVAILABILITY THROUGH PHIL AND CAREPOINT PHARMACY

Efficacy

Words "Proven medication + High-tech delivery. Treating migraine may never be the same"
Words "Proven medication + High-tech delivery. Treating migraine may never be the same"
Product image of Trudhesa™ Precision Olfactory Delivery (POD®) on black background facing left and  tilted down

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

Icon of Trudhesa™ nasal spray

Trudhesa with advanced POD technology achieved intravenous (IV)-like DHE plasma concentrations after 30 minutes2*

Icon of Trudhesa™ nasal spray

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.

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

DHE
N=105
Graphic 61%‡ Pale gold chevron pointing rightPale gold chevron pointing rightGold chevron Graphic 70%‡
Placebo
N=98
23% Pale gray chevron pointing rightPale gray chevron pointing rightGray chevron pointing right 28%

DHE
N=103
Graphic 47% Pale gold chevron pointing rightPale gold chevron pointing rightGold chevron pointing right Graphic 56%§
Placebo
N=102
33% Pale gray chevron pointing rightPale gray chevron pointing rightGray chevron pointing right 35%

DHE
N=103
Graphic 32% Pale gold chevron pointing rightPale gold chevron pointing rightGold chevron pointing right Graphic 48%§
Placebo
N=102
20% Pale gray chevron pointing rightPale gray chevron pointing rightGray chevron pointing right 22%

DHE
N=103
30% Pale gold chevron pointing rightPale gold chevron pointing rightGold chevron pointing right Graphic 47%
Placebo
N=102
20% Pale gray chevron pointing rightPale gray chevron pointing rightGray chevron pointing right 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

Icon of Trudhesa™ nasal spray

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

Graph of DHE plasma levels achieved comparing Trudhesa to IV DHE and traditional DHE nasal spray
Graph of DHE plasma levels sustained comparing Trudhesa to IV DHE and traditional DHE nasal spray
Icon of Trudhesa™ nasal spray

DHE bioavailability comparison

In a crossover study, Trudhesa provided approximately 4 times the maximum plasma concentration of traditional DHE spray.4

Graph of Trudhesa™ bioavailability vs traditional DHE nasal spray
Product image of Trudhesa™ Precision Olfactory Delivery (POD®) on black background facing left and tilted down
Product image of Trudhesa™ Precision Olfactory Delivery (POD®) vertical upright facing left on blue background

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

Icon of Trudhesa™ nasal spray

Rapid pain relief delivered

Pain Relief Postdose

Ad hoc analysis of first migraine attack treated with Trudhesa2

Graph showing percentage of patients achieving pain relief over time, with callouts for rapid relief and relief at 2 hours
Image of percent of patients' pain freedom after first dose of Trudhesa™
Image of percent of patients with freedom from their most bothersome symptom after first dose of Trudhesa™

Study patients using their best usual care reported a 30% rate of response at 2 hours.3

Icon of Trudhesa™ nasal spray

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.3

Image of data featuring patients who were pain free at 2 hours during the 24-week study, and the percentage of those who were still pain free at 24 hours and 48 hours

Of patients who reported pain freedom at 2 hours for their first treated migraine attack with Trudhesa, 93% were pain-free at 24 hours and 86% were still pain-free at 48 hours.1

#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

"85%"

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

Icon of Trudhesa™ nasal spray

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

Chart of bioavailability
Icon of Trudhesa™ nasal spray

No limited dosing window

Patients reported pain freedom despite delayed administration of Trudhesa2,3

Graph of patients who achieved pain freedom despite delayed dosing

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

Blue-tinted image of an actor portrayal of Trudhesa™ patient smiling with short, straight hair and looking to the right
Image of patient-reported data, comparing Trudhesa to prior treatment
Image of patient-reported data, with percent of patients in the safety study who said Trudhesa™ was easy to use at the end of treatment

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

Who May Benefit?

Blue-tinted image of an actor portrayal of  Trudhesa™ patient smiling with short hair and looking left

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.