Trudhesa Nasal Spray: A Newly FDA-Approved Acute Migraine Treatment

January 26, 2024
September 21, 2021
Trudhesa Nasal Spray: A Newly FDA-Approved Acute Migraine Treatment

Recently, there has been more good news for people with migraine. In early September 2021, the Food and Drug Administration (FDA) approved a new variation of medication - Trudhesa nasal spray for the acute treatment of migraine in adults. The Trudhesa nasal spray is a new and practical way to effectively deliver an existing drug that has been known to be effective for many years: “DHE” (also known as dihydroergotamine). It is a potent acute migraine medication that has been used for decades in multiple formulations, especially for difficult-to-treat migraine attacks. 

You may have received DHE before if you received intravenous treatment for a prolonged migraine attack at a hospital or at an infusion center. You may also have used another nasal spray to deliver DHE before, Migranal. Trudhesa nasal spray is meant to be a much improved method of nasal spray delivery, to increase efficacy and absorption and decrease side effects. There is no need to position your head in a certain way when using the Trudhesa nasal spray.

The spray has a special delivery mechanism to deliver the medication into your bloodstream through your nose. The advantage of this is that the medication does not need to be metabolized, and it can quickly act on migraine. This method of delivery is also very helpful for the people with migraine who have delayed emptying of their stomach (gastroparesis) or cannot take a pill by mouth due to severe nausea and vomiting. 

Another advantage is that DHE remains helpful even if you don’t use it as soon as your headache starts -- unlike triptans that should be taken as early as possible. With those, it can be stressful to try to figure out the optimal time to take an acute medication, and to potentially risk missing the window of opportunity to take it. DHE is also a good option if you wake up with a migraine attack and don’t know when the onset of the attack began. 

The clinical trial investigating Trudhesa was called “STOP 301”.  In this trial, 360 healthy participants aged 18 to 65 years old with less than 15 headache days per month were enrolled, and they were allowed to use Trudhesa a maximum of 2 times per day and 3 days per week. Two thirds of participants had pain relief (66%), more than one third (38%) had pain freedom, and about half (52%) had relief from their most bothersome migraine symptom 2 hours after taking the medication. Pain relief was quick; 16% of patients noted pain relief at 15 minutes and 29.6% at 30 minutes. There was no placebo control group. The majority of participants (83%) also found the medication to be easy to use. 

More than a third of participants (36.7%) did experience side effects. The most common side effects were nasal congestion (16.7%), nausea (7.9%), nasal discomfort (5.4%), and abnormal taste (5.1%). Some of the participants were followed for about 1 year (52 weeks) and no serious side effects were observed. The side effect profile is similar to other acute nasal spray medications for migraine and other formulations of DHE.  

As with any medications, please discuss with your doctor if Trudhesa nasal spray is an appropriate option for you, especially given any other medications you may be taking.  If you don't have a neurologist to treat your headaches, you can sign up for a membership to Neura Health, where a video visit with a neurologist is included.  Like gepants (Ubrelvy and Nurtec), Trudhesa cannot be taken if you take strong CYP3A4 inhibitors such as grapefruit, certain antibiotics,  or certain blood pressure medications, for example. 

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Olivia Begasse De Dhaem, MD
Dr. Olivia Begasse de Dhaem is a board-certified and fellowship-trained neurologist and headache specialist, and an Advisor to Neura Health.
About the Author
Dr. Olivia Begasse de Dhaem is a board-certified neurologist and Headache Specialist at Hartford HealthCare in Milford CT. She graduated from Columbia University College of Physicians medical school. She attended her neurology residency at the Columbia University Neurological Institute. She completed her headache medicine fellowship at Harvard University. She is an emerging leader of the American Headache Society. She is involved in advocacy and feels strongly about supporting people with headache disorders in the workplace.

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