Who May Benefit?
Patient dissatisfaction is underreported—96% of survey patients said they were dissatisfied with at least one aspect of their migraine treatment¹*
Adding Trudhesa® to your treatment toolbox could benefit patients like these:
All patient images are actor portrayals.
*In a survey of 3930 US adults with migraine who reported use of oral acute prescription medication.1
Morning migraine with nausea
Patient history
- Has about 4 to 5 migraine days per month accompanied with nausea; worst migraine attacks either come on rapidly or start before he wakes up
- Attacks come on quickly; oral triptan can’t provide pain relief
- Misses 1 to 2 days of work every month
CHIEF COMPLAINT
Needs a reliable treatment that can provide pain freedom, even when taken late into an attack
Migraine attacks that break through while on prevention
Patient history
- Diagnosed with migraine in high school
- Has significant photosensitivity, but can’t wear sunglasses due to allodynia
- Cannot tolerate triptans, and has been on a preventive anti-CGRP for a year, which has reduced her headache frequency by about half
- Has tried gepants to treat her remaining attacks; however, they do not provide adequate pain freedom
CHIEF COMPLAINT
Needs a reliable and tolerable treatment that works differently from current medication and delivers pain freedom even when taken late into an attack
Long-lasting migraine, headache recurrence
Patient history
- Experiences attacks that last a couple days, especially when attacks are associated with menstruation
- Has been on an anti-CGRP and treats attacks with a gepant but struggles with getting sustained relief, often having to take multiple doses
- Worries her attacks will keep her away from work for too long or result in missing family events
CHIEF COMPLAINT
Needs a medication that can provide rapid and sustained relief with one dose, even if taken late
Dissatisfied with migraine treatment, has controlled hypertension
Patient history
- Has a long history of migraine with aura; attacks cause her to cancel plans for the day
- Has no other medical problems aside from hypertension that is under control with hydrochlorothiazide
- Cannot get consistent relief with her triptan or gepant, so she’s inquiring about a more effective acute treatment
CHIEF COMPLAINT
Needs a reliable and tolerable treatment that can act fast and provide pain freedom, even if taken late
Be Direct.
It may help them get the relief they need.
Consider asking your patients these questions to see if they may be right for Trudhesa:
- “Does a single dose of your current medication give you the migraine symptom relief you need for at least 24 hours?”7
- “Do you feel like you can rely on your current acute medication to work when you need it to?”5,7-9
- “Do you ever have any stomach issues or nausea when you’re having a migraine attack?”10,11
- “Are you always able to take your migraine pill or dissolving tablet early enough for it to work?”3,12
Safety
References: 1. Lipton RB, Munjal S, Buse DC, et al. Unmet acute treatment needs from the 2017 Migraine in America Symptoms and Treatment Study. Headache. 2019;59(8):1310-1323. 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. Headache. 2021;61(8):1214-1226. 3. Data on File. Impel Pharmaceuticals. 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. Silberstein SD, Shrewsbury SB, Hoekman J. Dihydroergotamine (DHE) – then and now: a narrative review. Headache. 2020;60(1):40-57. 6. Craig K, Jeleva M, Hocevar-Trnka J. Cardiovascular safety results of INP104 (POD-DHE) from the STOP 301 phase 3 study. Poster presented at: American Headache Society Virtual Annual Scientific Meeting, June 3-6, 2021. 7. 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. 8. Wells RE, Markowitz SY, Baron EP, et al. Identifying the factors underlying discontinuation of triptans. Headache. 2014;54(2):278-289. 9. Sheftell FD, Feleppa M, Tepper SJ, Volcy M, Rapoport AM, Bigal ME. Patterns of use of triptans and reasons for switching them in a tertiary care migraine population. Headache. 2004;44(7):661-668. 10. Aurora SK, Papapetropoulos, Kori S. Gastric stasis in migraineurs: etiology, characteristics, and clinical and therapeutic implication. Cephalalgia. 2013;33(6):408-415. 11. Trudhesa. Prescribing information. Impel Pharmaceuticals; 2021. 12. Aurora SK, Ray S, Satterly K, Shrewsbury SB, Hoekman J. Does dihydroergotamine treat the “whole migraine”? Poster presented at: American Headache Society Virtual Annual Scientific Meeting, June 2020.
In the Trudhesa safety study,
Pain freedom was delivered late in an attack2,3
TRUDHESA SAFETY STUDY2
This was a phase 3, open-label, 52-week safety study with exploratory efficacy end points. Primary end points included TEAEs and change in upper nasal mucosa and olfactory function. Secondary end points were changes in vital signs, physical examinations, 12-lead ECG, and laboratory evaluations. Exploratory end points (self-reported) were pain freedom, most bothersome symptom freedom at 2, >2 to 4, and >4 hours, pain relief at 2 hours, and recurrence of migraine pain through 24 and 48 hours.
In the comparative bioavailability study, Trudhesa:
Consistently delivered DHE via POD for pain relief without the initial peak concentration of IV DHE2,4,5
- Reached effective plasma concentrations in 30 minutes, steadily for well-established tolerability
- Sustained plasma concentration levels comparable to IV DHE (1.0 mg) and Cmax through 48 hours4
TRUDHESA BIOAVAILABILITY STUDY4
This was a phase 1, open-label, randomized, single-dose, 3-period, 3-way crossover study of Trudhesa, IV DHE, and the traditional nasal spray. A total of 38 healthy volunteers aged 18 to 55 years, with no significant medical history were enrolled in the study. End points of the study were safety, tolerability, and bioavailability of DHE following a single-dose administration of Trudhesa 1.45 mg compared with IV DHE 1.0 mg and a traditional DHE nasal spray (2.0 mg).*
*Pretreatment with an antiemetic (metoclopramide 10 mg, delivered by slow IV push over 1 to 2 minutes, 5 to 10 minutes prior to DHE dosing) was given in all 3 treatment arms.
In the Trudhesa safety study,
Trudhesa delivered pain freedom for patients2
Study patients using their best usual care reported a 30% rate of response at 2 hours.3
Trudhesa delivered rapid pain relief for patients2
Pain Relief Post-Dose
Ad hoc analysis of first migraine attack treated with Trudhesa
TRUDHESA SAFETY STUDY2
This was a phase 3, open-label, 52-week safety study with exploratory efficacy end points. Primary end points included TEAEs and change in upper nasal mucosa and olfactory function. Secondary end points were changes in vital signs, physical examinations, 12-lead ECG, and laboratory evaluations. Exploratory end points (self-reported) were pain freedom, most bothersome symptom freedom at 2, >2 to 4, and >4 hours, pain relief at 2 hours, and recurrence of migraine pain through 24 and 48 hours.
In the Trudhesa safety study,
Trudhesa delivered sustained pain freedom2
Of the 4257 migraine attacks treated during the
24-week study, where Trudhesa was used first
TRUDHESA SAFETY STUDY2
This was a phase 3, open-label, 52-week safety study with exploratory efficacy end points. Primary end points included TEAEs and change in upper nasal mucosa and olfactory function. Secondary end points were changes in vital signs, physical examinations, 12-lead ECG, and laboratory evaluations. Exploratory end points (self-reported) were pain freedom, most bothersome symptom freedom at 2, >2 to 4, and >4 hours, pain relief at 2 hours, and recurrence of migraine pain through 24 and 48 hours.
*Data are self-reported. Excludes migraine attacks that started at baseline and ended in Weeks 1-24 with acute medication use in both periods. These analyses were exploratory in nature and no statistics were done.2,3
Trudhesa demonstrated a well-established safety profile in a phase 3 trial that included CV assessment2,6
CV-related results6*
- No treatment-related cardiac events
- Minimal changes from baseline in systolic and diastolic blood pressure and median heart rate over 24 weeks
- No clinically significant ECG interpretations or TEAEs associated with an abnormal ECG
- Over 24 weeks, 1.4% (5/354) of patients experienced adverse vascular events
- 0.3% of patients (1/354) experienced adverse vascular events (ie, mild hypertension) related to Trudhesa
*5.1% (18/354) of study patients had cardiac disorders. Patients were excluded if they had a history of CV events or presented with significant risk factors for CV disease. Patients with a history of hypertension could enroll if hypertension was stable and well-controlled on current therapies for >6 months, provided no other risks were present. ECG and blood pressure were regularly collected over the course of the study but do not correlate with when patients administered Trudhesa.
Trudhesa delivered rapid pain relief for patients2
Pain Relief Post-Dose
Ad hoc analysis of first migraine attack treated with Trudhesa2
TRUDHESA SAFETY STUDY2
This was a phase 3, open-label, 52-week safety study with exploratory efficacy end points. Primary end points included TEAEs and change in upper nasal mucosa and olfactory function. Secondary end points were changes in vital signs, physical examinations, 12-lead ECG, and laboratory evaluations. Exploratory end points (self-reported) were pain freedom, most bothersome symptom freedom at 2, >2 to 4, and >4 hours, pain relief at 2 hours, and recurrence of migraine pain through 24 and 48 hours.