FDA Approves Trudhesa Nasal Spray to Treat Migraines

The Food and Drug Administration (FDA) approved Impel NeuroPharma’s Trudhesa in early September to treat acute migraines with or without aura. The nasal spray is approved for use in adults.

Trudhesa (generic name: dihydroergotamine mesylate) will be dispensed with a prescription through Trudhesa Direct, a pharmacy partnership and copay program that will deliver the medication to patients’ homes at no additional cost.

“We are delighted with the approval of Trudhesa and are proud to offer the millions of Americans with migraine a non-oral, acute treatment option that may provide rapid, sustained, and consistent relief, even when taken late into a migraine attack,” Adrian Adams, chairman and chief executive officer of Impel NeuroPharma, said in a press release.

Road to Approval

Trudhesa delivers dihydroergotamine mesylate (DHE), a proven medication for migraines, quickly to the bloodstream through the nasal passages. This allows the medication to be quickly absorbed, giving patients fast relief.

“Trudhesa is a new formulation of DHE,” Amit Sachdev, MD, medical director in the department of neurology at Michigan State University, tells Verywell. “We have been using DHE in the care of migraine patients for many years and most neurologists are very aware of this medication. DHE is often used to break a migraine headache after it has already started.”

This kind of medication for migraines isn't new.

“This drug has been out for a long time,” Medhat Mikhael, MD, pain management specialist and medical director of the non-operative program at the Spine Health Center at MemorialCare Orange Coast Medical Center in California, tells Verywell. “The only difference between the old medication and this one is the way that it’s delivered.”

During a phase 3 clinical trial, more than 5,650 migraine attacks were treated over 24 or 52 weeks. The researchers discovered that 38% of patients stopped experiencing migraine pain while using Trudhesa.

Sixty-six percent of participants experienced pain relief, and 52% got rid of their most bothersome migraine symptom two hours after their first dose of Trudhesa. For 16% of patients, relief started as quickly as 15 minutes after they used the medication.

For patients who were pain-free two hours after taking the medication, 93% still did not have pain 24 hours later and 86% were free of pain two days later. The majority of patients—84%—said that Trudhesa was easy to use and that they preferred it over their current migraine treatment.

What to Know About Trudhesa

DHE is already available in an IV and nasal spray form, Kevin Weber, MD, a neurologist who specializes in treating patients with headaches and migraines at The Ohio State University Wexner Medical Center, tells Verywell.

However, he says, “this device delivers a more precise nasal dose of medication to the upper nasal space. The medication is to be absorbed in the blood vessel of the nasal space and therefore bypasses the GI tract. The goal is for the medication to work faster this way and also ensure efficacy in patients with nausea and vomiting.” 

"[DHE is] often reached for in the emergency department, when a migraine has been ongoing for a long time and might be quite intense,” Sachdev adds.

How to Take Trudhesa

Trudhesa is available by prescription and can help provide relief to patients with migraines with or without aura. 

A recommended dose of Trudhesa is 1.45 milligrams (one spray of 0.725 milligrams into each nostril), and the dose may be repeated at least one hour after the first dose. However, more than two doses should not be used within a 24 hour period and patients should not exceed three doses within seven days.

Accessibility and Limitations of Trudhesa

The FDA has a list of patients who should not take Trudhesa. Those include:

• People who are taking strong CYP3A4 inhibitors, like protease inhibitors (ritonavir, nelfinavir, or indinavir), macrolide antibiotics (erythromycin or clarithromycin), and antifungals (ketoconazole or itraconazole)
• People with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or patients who have clinical symptoms or findings consistent with coronary artery vasospasm, including Prinzmetal's variant angina
• People with uncontrolled hypertension
• People with peripheral arterial disease
• Patients who have sepsis
• People who recently had vascular surgery
• Patients with severe hepatic impairment
• Patients with severe renal impairment
• Patients with known hypersensitivity to ergot alkaloids
• People who recently used, within 24 hours, other 5-HT1 agonists (sumatriptan) or ergotamine-containing or ergot-type medications
• Patients who are using peripheral and central vasoconstrictors

Known Side Effects

During the 52-week clinical trial, some of the most commonly reported side effects included:

• Nasal congestion (17.8% of patients)
• Nausea (6.8%)
• Nasal discomfort (6.8%)
• An abnormal olfactory test (6.8%)
• Vomiting (2.7%) 

Getting Trudhesa to Treat Your Migraines

Impel plans to charge between $600 and $850 for four doses of Trudhesa, Reuters reported. However, your health insurance should cover at least part of the cost of the medication.

“The data is solid,” Weber says. “I just have concerns about cost and access for this drug that has been available in some form for over 70 years.”

Trudhesa will be available to patients starting in October 2021.