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Words 'It's truly bizarre how well this thing works'

Trudhesa™ unites a trusty drug with gentle delivery

Time-tested and long-lasting

The medication in Trudhesa is called DHE or, if you want to get technical, dihydroergotamine mesylate. It has been used by specialists and hospitals for years. DHE is known for working when nothing else will.

Words 'About 2 out of 3 people had pain relief at 2 hours'
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The result from a previous study of DHE with nasal spray delivery showed
In 4 previous studies of people using DHE with an older nasal spray device, many had no pain or mild pain at 2 hours.
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Study 1

About 2 out of 3 people had pain relief

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Study 2

About half of people had pain relief

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Studies 3 and 4

3 out of 10 people had pain relief

Today, DHE is together with advanced delivery technology and ready to provide relief on demand.

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Precision Olfactory Delivery but you can call it POD®

POD is designed to gently deliver medication to the ideal place in your nose for rapid absorption into your circulation. And that place is the upper nasal space.

See why the upper nasal space is the place to be

Play 'Why the upper nasal space' video
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TITLE: WHY THE UPPER NASAL SPACE MAY BE THE IDEAL ROUTE TO RELIEF
VOICE OVER: The upper nasal space is a unique and underutilized environment for drug delivery. The ciliated olfactory epithelium in this richly vascularized space makes it ideal for rapid absorption into the systemic circulation, potentially leading to a faster response than oral medications. Potential benefits of delivery to this space also include the reduction of drug-related adverse effects and potential avoidance of delayed absorption in the GI tract and first-pass metabolism in the liver.
Traditionally, nasal drug administration has focused on delivery to the lower nasal space, which is associated with significant drug loss from the nose with existing delivery systems, which may lead to variability in absorption. In addition, deep inspiration associated with existing systems can collapse the nasal valve essentially blocking access to the vascular rich upper nasal space.
The mucosal layer in the upper nasal space tends to be more permeable and stable than the lower nasal cavity, permitting consistent, faster and more extensive absorption of drug into the underlying vasculature with less mucociliary clearance.
ONSCREEN: WHY THE UPPER NASAL SPACE MAY BE THE IDEAL ROUTE TO RELIEF

Illustration of a silhouette of a person looking to the left with arrows pointing to the upper and lower nasal space, blood circulation, and central nervous system

There’s nasal, and then there’s upper nasal

This area of the nose is rich in blood vessels, so medications can be quickly absorbed into your circulation.

It also means that the drug doesn't need to take the journey through your gastrointestinal (GI) tract before it can start to work.

What relief at the ready could mean for you

And what exploratory results from a 24-week study of the safety showed, where 4515 migraine attacks were treated with Trudhesa.

In some people, Trudhesa was:

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Word 'Speedy'
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Relief can start in as early as 15 minutes*

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Pain freedom at 2 hours — more than half of people were free from their most bothersome symptom at 2 hours*

Word 'Steady'
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With just 1 dose pain freedom was sustained for 2 whole days*

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9 out of 10 people who were pain free at 2 hours were still pain free at 48 hours*

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Of all the migraine attacks treated, 85% didn’t require a second dose, and those who got relief with Trudhesa once, were likely to get relief again

Words 'At the ready'
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Rates of pain freedom were the same whether people took Trudhesa within 2 hours or several hours into a migraine attack*

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*Exploratory efficacy outcomes are based on patient reports and post hoc analyses from a phase 3, open-label safety study of Trudhesa.

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Be Direct.

See what people with migraine who took part in the study said:

Words 'About 84% agreed (or strongly agreed) Trudhesa was easy to use' Words 'About 84% agreed (or strongly agreed) Trudhesa was easy to use'

When people compared Trudhesa to their regular migraine medication, more than half said Trudhesa:

  • Worked faster
  • Lasted longer
  • Was more consistent
  • Got them back to normal activities quicker
  • †Results were from a poststudy questionnaire, which asked 354 people with migraine to rate their experience with Trudhesa against their best usual care. The results were patient-reported and not validated.

Other things you need to know

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Before taking Trudhesa, talk to your healthcare provider (HCP) about all the medications you are taking

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Do not take Trudhesa if you are pregnant, planning to become pregnant, or nursing

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Before taking Trudhesa, talk to your HCP if you have, or think you may have, any cardiovascular (CV) disease risks‡

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Trudhesa was not associated with drowsiness

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Trudhesa can be taken twice within a 24-hour period, if needed, and 3 times over the course of a week

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Generally low levels of nausea were seen with Trudhesa

More questions? See FAQs

  • ‡People with migraine were excluded if they had a history of CV events or presented with significant risk factors for CV disease. But people with a history of hypertension, if stable and well controlled on current therapies for >6 months, could enroll if no other risks were present.
Getting Trudhesa
Stay Informed
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How to Use

Important Safety Information

Serious or potentially life-threatening reductions in blood flow to the brain or extremities due to interactions between dihydroergotamine (the active ingredient in Trudhesa) and strong CYP3A4 inhibitors (such as protease inhibitors and macrolide antibiotics) have been reported rarely. As a result, these medications should not be taken together.
Indication
Trudhesa is used to treat an active migraine headache with or without aura in adults. Do not use Trudhesa to prevent migraine when you have no symptoms. It is not known if Trudhesa is safe and effective in children.
Do not use Trudhesa if you:
  • Have any disease affecting your heart, arteries, or blood circulation
  • Are taking certain anti-HIV medications known as protease inhibitors (such as ritonavir or nelfinavir)
  • Are taking a macrolide antibiotic such as clarithromycin or erythromycin
  • Are taking certain antifungals such as ketoconazole or itraconazole
  • Have taken certain medications such as triptans or ergot-type medications for the treatment or prevention of migraine within the last 24 hours
  • Have taken any medications that constrict your blood vessels or raise your blood pressure
  • Have severe liver or kidney disease
  • Are allergic to ergotamine or dihydroergotamine
Before taking Trudhesa, tell your doctor if:
  • You have high blood pressure, chest pain, shortness of breath, heart disease; or risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease or you are postmenopausal, or male over 40); or problems with blood circulation in your arms, legs, fingers, or toes.
  • You have or had any disease of the liver or kidney.
  • You are taking any prescription or over-the-counter medications, including vitamins or herbal supplements.
  • You are pregnant, planning to become pregnant or are nursing, or have ever stopped medication due to an allergy or bad reaction.
  • This headache is different from your usual migraine attacks.

The use of Trudhesa should not exceed dosing guidelines and should not be used on a daily basis.

Serious cardiac (heart) events, including some that have been fatal, have occurred following the use of dihydroergotamine mesylate, particularly with dihydroergotamine for injection, but are extremely rare.

You may experience some nasal congestion or irritation, altered sense of taste, sore throat, nausea, vomiting, dizziness, and fatigue after using Trudhesa.

Contact your doctor immediately if you experience:

  • Numbness or tingling in your fingers and toes
  • Severe tightness, pain, pressure, heaviness, or discomfort in your chest
  • Muscle pain or cramps in your arms or legs
  • Cold feeling or color changes in 1 or both legs or feet
  • Sudden weakness
  • Slurred speech
  • Swelling or itching

The risk information provided here is not comprehensive. To learn more, talk about Trudhesa with your healthcare provider or pharmacist. The FDA-approved product labeling can be found at www.trudhesa.com or 1-800-555-DRUG. You can also call 1-833-TRUDHESA (1-833-878-3437) for additional information.