FDA approves new nasal spray therapy for migraine relief within 15 minutes

On September 3, 2021, Impel NeuroPharma announced that the U.
S.
FDA approved Dihydroergotamine mesylate (DHE) nasal spray Trudhesa (formerly known as INP104) for the acute treatment of adult migraine (with or without aura)
.

Migraine is a disease that affects the whole body and is the second leading cause of disability
.
It is characterized by recurrent moderate to severe headaches, accompanied by nausea, vomiting, and sensitivity to light and sound

In the past, dihydroergotamine mesylate was often used for the treatment of migraine
.
Although very effective, it has dose-related side effects and is not easy to use

Picture source: reference [1]

Trudhesa avoids gastrointestinal symptoms and potential absorption problems caused by oral medications, and provides rapid, continuous, and consistent symptom relief without the need for injections or infusions, even when administered within a few hours after a migraine attack
.
This innovative non-oral delivery system will allow patients to self-administer medication anywhere and at any time during a migraine attack

This approval is based on the positive results of the pivotal Phase 3 clinical trial STOP301, which included 5650 migraine attacks
.
The results of this trial indicate that Trudhesa is generally well tolerated, and exploratory efficacy results show that it can provide rapid, sustained, and consistent symptom relief

Specifically, more than one-third of patients (38%) reported no pain after treatment, two-thirds of patients (66%) had pain relief, and more than half of patients (52%) reported no pain after the first use of Trudhesa.
I got rid of the most annoying migraine symptoms at a young age
.
One in six patients (16%) showed pain relief as early as 15 minutes after the administration

No serious treatment-related adverse events were observed in the trial, and most treatment-related adverse events were mild and short-term
.
Throughout the 52-week trial period, the most common treatment-related adverse events (≥2%) were nasal congestion (17.

Mr.

Reference materials:

[1] Impel NeuroPharma Announces US FDA Approval of Trudhesa™ (Dihydroergotamine Mesylate) Nasal Spray for the Acute Treatment of Migraine.