Trudhesa (dihydroergotamine mesylate) nasal spray is now available for the acute treatment of migraine with or without aura in adults.
Trudhesa uses proprietary technology to deliver a lower dose (0.725mg per spray) of dihydroergotamine mesylate to the upper nasal space. The therapeutic activity of dihydroergotamine in migraine is generally attributed to the agonist effects at 5-HT1D receptors.
The approval was based on data from the open-label phase 3 STOP 301 study (ClinicalTrials.gov Identifier: NCT03557333), which evaluated the safety and tolerability of Trudhesa in 354 adults who had a documented diagnosis of migraine with or without aura, including at least 2 attacks per month for the previous 6 months. Findings from the study demonstrated that treatment with Trudhesa was generally well tolerated with no new safety signals. Moreover, additional exploratory efficacy data showed that Trudhesa provided rapid, sustained, and consistent symptom relief.
The most common adverse reactions reported with Trudhesa were rhinitis, nausea, altered sense of taste, application site reactions, dizziness, vomiting, somnolence, pharyngitis, and diarrhea.
Prior to initiation, a cardiovascular evaluation is recommended. It is also strongly recommended that for patients with risk factors predictive of coronary artery disease who are determined to have a satisfactory cardiovascular evaluation, the first dose of Trudhesa be administered in the setting of an equipped healthcare facility, unless the patient has previously received dihydroergotamine mesylate. Immediately after the first dose is administered, an electrocardiogram is recommended in patients with risk factors because ischemia can occur in the absence of clinical symptoms.
Trudhesa is supplied as a package of 4 single-dose units with 1 nasal spray device; each unit contains a vial of dihydroergotamine mesylate 4mg. Each spray delivers 0.725mg of dihydroergotamine mesylate; the recommended dose is 1.45mg administered as 2 metered sprays into the nose (1 spray of 0.725mg into each nostril).
The Company is also offering a patient assistance program for eligible patients.
- Impel NeuroPharma announces Trudhesa™ (dihydroergotamine mesylate) nasal spray is now available for prescription for the acute treatment of migraine. News release. Impel NeuroPharma. Accessed September 29, 2021. https://www.globenewswire.com/news-release/2021/09/28/2304465/0/en/Impel-NeuroPharma-Announces-Trudhesa-Dihydroergotamine-Mesylate-Nasal-Spray-is-Now-Available-for-Prescription-for-the-Acute-Treatment-of-Migraine.html.
- Trudhesa. Package insert. Impel NeuroPharma; 2021. Accessed September 7, 2021. https://www.trudhesa.com/trudhesa-prescribing-information.pdf.