Safety

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

  • A total of 5099 doses of Trudhesa were self-administered by 354 patients over the first 24 weeks of the study to treat 4515 migraine attacks2
  • Nasal safety was the primary focus3
  • 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 use3

In a comparative bioavailability study, Trudhesa was shown to be statistically biocomparable to established DHE migraine treatments.4

Safety and tolerability profile


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.5

The Trudhesa safety study (N=354)

Local irritative symptoms reported by ≥1% of patients during the 6- or 12-month study.5

TRUDHESA
(N=354)


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.5*

CV-related results

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.3,5

  • No treatment-related cardiac events3
  • No clinically significant ECG interpretations or TEAEs associated with an abnormal ECG3
  • Over 24 weeks, 1.4% (5/354) patients experienced adverse vascular events related to treatment3

*52% of patients experienced any local irritative symptom.5

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

Efficacy

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 NeuroPharma; 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. 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. 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. Data on File. Impel Neuropharma. 2020. 5. Trudhesa. Prescribing information. Impel Neuropharma; 2021.