For the acute treatment of migraine in adults.
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Benefits of DHE and Precision Olfactory Delivery (POD®) technology.1,2

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 hours.1

Prescribe Trudhesa

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 hours.1

Trudhesa® with advanced POD technology consistently delivered DHE without the initial peak concentration of intravenous (IV) DHE.2
Trudhesa® demonstrated rapid, sustained, consistent relief, even when taken late into an attack.2,3*

*Based on a phase 3, open-label, safety study evaluating exploratory efficacy outcomes and post hoc analyses.2

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 Of the 4257 migraine attacks treated during the 24-week study, where Trudhesa was used first 85% did not require rescue medication.2,3
For the first migraine attack treated with Trudhesa2:

38%

of patients were pain free (126/332)

At 2 hours.

93%

Still Migraine Free (117/126)

At 24 hours.

86%

Still Migraine Free (108/126)

At 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.3

Results from the Trudhesa comparative bioavailability study.

Consistently delivered DHE via POD without the initial peak concentration of IV DHE4

Trudhesa reached effective plasma concentrations in 30 minutes, steadily for well-established tolerability.4

View Full Trial Design

Trudhesa provides ~4 times the bioavailability
of traditional DHE spray.5

Trudhesa Difference

The clinical efficacy studies
of a traditional DHE nasal spray product.1

A traditional DHE nasal spray product was evaluated in 4 randomized, double-blind, placebo-controlled studies.1

Study 1
2 Hours 4 Hours
DHE
N=105
61%‡ 70%‡
Placebo
N=98
23% 28%
Study 2
2 Hours 4 Hours
DHE
N=103
47% 56%
Placebo
N=102
33% 35%
Study 3
2 Hours 4 Hours
DHE
N=50
32% 48%
Placebo
N=50
20% 22%
Study 4
2 Hours 4 Hours
DHE
N=47
30% 47%
Placebo
N=50
20% 30%

Percentage of patients who reported mild or no pain† following a single treatment.1

View Full Trial Design

†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 or 5-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

Rapid pain relief delivered.

Pain Relief Post-Dose

Ad hoc analysis of first migraine attack treated with Trudhesa.2

Consistent results delivered.

Trudhesa provides consistent absorption and reliable relief by delivering proven DHE to the upper nasal space via POD.1,4

How to Use

Pain freedom delivered late in an attack.

Patient-reported results.#

As part of the Trudhesa safety study, patients kept a daily e-diary and completed questionnaires about Trudhesa as compared to their best usual care.2**

54%+

of patients reported that Trudhesa worked faster, lasted longer, was more consistent, and got them back to normal activities quicker than their prior treatment.7#

84%

of patients said Trudhesa was easy to use.2#

# 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

**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

References: 1. Trudhesa. Prescribing information. Impel Pharmaceuticals; 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. 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. 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.

Trudhesa bioavailability study

This was a phase 1, open-label, randomized, single-dose, 3-period, 3-way crossover study. Subjects were screened for up to 21 days before randomization into 1 of 6 sequences, dictating the order of the 3 treatments to produce a balanced crossover, with a 7-day washout between each treatment.*

Subjects:

A total of 38 healthy volunteers aged 18 to 55 years, with no significant medical history were enrolled in the phase 1 study.

End points:

The safety, tolerability, and bioavailability of DHE following a single-dose administration of Trudhesa 1.45 mg was compared with IV DHE 1.0 mg and DHE nasal spray 2.0 mg in healthy adult subjects.

Traditional DHE nasal spray

Studies 1 and 2

In studies 1 and 2, doses of 2 mg or 3 mg DHE treatment were assessed. For a single treatment, the higher dose showed no advantage over the lower dose. A 4-point pain intensity scale was used to evaluate responses.1

Studies 3 and 4

In studies 3 and 4, a total dose of 2 mg was compared with placebo. A 5-point scale was used that included pain response.1