For the acute treatment of migraine in adults.
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Trudhesa® demonstrated a well-established safety profile in a phase 3 trial that included cardiovascular assessment.¹

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The Trudhesa safety study was the largest longitudinal study ever conducted with dihydroergotamine mesylate (DHE) using nasal spray delivery.¹

  • Over 6,300 doses of Trudhesa were self-administered over the course of the 52-week study, and only 0.6% of doses resulted in nausea.2
  • Nasal safety was the primary focus.3
  • CV effects (treatment emergent adverse events, eg, concomitant medication use, vital signs, and ECGs) were regularly collected and reviewed against preexisting conditions and concomitant medication use.3
Prescribe Trudhesa
The Trudhesa safety study (N=354).

Local irritative symptoms reported by ≥1% of patients during the 6– or 12–month study.4

Local irritative symptoms were nasopharyngitis, rhinitis, nasal discomfort, product taste abnormal/dysgeusia, sinusitis, sinus discomfort, olfactory test abnormal, epistaxis, pharyngitis, nasal mucosal disorder, change in smell, ear discomfort, and rhinorrhea.4*

Inclusion criteria:

  • Patients with stable hypertension and concomitant triptan use were included in the safety study.†
  • However, concomitant use of triptans within 24 hours was disallowed. Patients were excluded if they had a history of CV events or presented with significant risk factors for CV disease.3,4 
CV-related results3:
  • 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) patients experienced adverse vascular events
  • 0.3% of patients (1/354) experienced adverse vascular events (ie, mild hypertension) related to Trudhesa

Inclusion criteria:

  • Patients with stable hypertension and concomitant triptan use were included in the safety study.†
  • However, concomitant use of triptans within 24 hours was disallowed. Patients were excluded if they had a history of CV events or presented with significant risk factors for CV disease.3,4 

CV-related results3:

  • 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) patients experienced adverse vascular events
  • 0.3% of patients (1/354) experienced adverse vascular events (ie, mild hypertension) related to Trudhesa

*52% of patients experienced any local irritative symptom.4

†Patients with stable CV disease were included in clinical trials if they had no acute episodes 6 months before entering the trial.3 

Well-established safety and tolerability profile with DHE.

The placebo-controlled studies of a traditional DHE nasal spray product.

Adverse reactions reported by ≥1% of patients and more frequently than in the placebo group. Of the 1796 patients and subjects treated with DHE nasal spray doses ≤2 mg, 26 (1.4%) discontinued because of adverse events.4

ADVERSE REACTION DHE NASAL SPRAY
(N=597)		 PLACEBO
(N=631)
Rhinitis 26% 7%
Nausea 10% 4%
Altered Sense of Taste 8% 1%
Application Site Reaction 6% 2%
Vomiting 4% 1%
Dizziness 4% 2%
Pharyngitis 3% 1%
Somnolence 3% 2%
Diarrhea 2% <1%
Hot Flashes 1% <1%
Asthenia 1% 0%
Stiffness 1% <1%

References: 1. Impel NeuroPharma announces U.S. Food & Drug administration acceptance of new drug application for INP104 for the acute treatment of migraine [press release]. Impel Pharmaceuticals; January 20, 2021. https://impelnp.com/2021/01/20/impel-neuropharma-announces-u-s-food-drug-administration-acceptance-of-new-drug-application-for-inp104-for-the-acute-treatment-of-migraine/. Accessed September 10, 2021. 2. Randle L, Aurora SK, Hocevar-Trnka J, et al. Reduced nausea when dihydroergotamine mesylate is delivered by INP104. Poster presented at: American Headache Society Virtual Annual Scientific Meeting, June 3-6, 2021. 3. 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. 4. Trudhesa. Prescribing information. Impel Pharmaceuticals; 2021. 5. 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.