Phil Announces Partnership with Impel NeuroPharma in Support of Trudhesa™ (dihydroergotamine mesylate) Nasal Spray for the Acute Treatment of Migraine

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Phil Inc.

Sep 29, 2021, 18:47 ET

SAN FRANCISCO, Sept. 29, 2021 /PRNewswire/ -- Phil, Inc. announces partnership with Impel NeuroPharma, Inc. (NASDAQ: IMPL) in support of Trudhesa™ (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) to provide technology-powered patient support and distribution services through Phil's proprietary workflow to enhance the patient's access to therapy. Trudhesa is indicated for the acute treatment of migraine with or without aura in adults. 

"Phil provides an efficient and value-driven experience for patients to get timely and affordable access to their medications," said Deepak Thomas, founder and CEO of Phil.  "The challenges in this space reach far beyond the patient, and our goal is to simplify this complex ecosystem to deliver positive outcomes for all stakeholders."

"Every step of our Trudhesa development program has been guided by the needs of people living with migraine," said Adrian Adams, Chairman and Chief Executive Officer, Impel NeuroPharma. "That's why we're excited to partner with Phil on Trudhesa Direct™, a streamlined, customized, end-to-end process that will automatically enroll eligible, commercially-insured patients in a savings program to obtain and conveniently ship the medication straight to their home at no additional cost. This partnership will create a customized and seamless experience for patients who choose Trudhesa for rapid, sustained and consistent migraine relief." 

About Trudhesa™ (dihydroergotamine mesylate) Nasal Spray
Trudhesa™ (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) is approved by the U.S. Food and Drug Administration for the acute treatment of migraine with or without aura in adults in the U.S. Using Impel's proprietary Precision Olfactory Delivery (POD®) Technology, Trudhesa gently delivers dihydroergotamine mesylate (DHE)—a proven, well-established therapeutic —quickly to the bloodstream through the vascular-rich upper nasal space. Trudhesa bypasses the gut and potential absorption issues, offering the potential for rapid, sustained, and consistent relief without injection or infusion, even when administered hours after the start of a migraine attack.i

Trudhesa Indication and Important Safety Information

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.

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.

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.

About Impel NeuroPharma
Impel NeuroPharma, Inc. is a commercial-stage biopharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs, with an initial focus on diseases of the central nervous system. Impel offers and is developing treatments that pair its proprietary Precision Olfactory Delivery (POD®) technology with well-established therapeutics. In addition to Trudhesa™ (dihydroergotamine mesylate) nasal spray, which is approved in the United States for the acute treatment of migraine with or without aura in adults, Impel is also developing INP105 for the acute treatment of agitation and aggression in patients with autism, and INP107 for OFF episodes in Parkinson's disease.

Impel, POD, Trudesa and Trudhesa Direct are trademarks of Impel NeuroPharma, Inc.

About Phil, Inc:
Phil is a software therapy deployment platform, offering pharmaceutical manufacturers a modern alternative to traditional access, affordability and distribution options. Through its digital stakeholder experiences, patient access services, market access solutions and distribution models, pharma manufacturers are able to deliver affordable and timely therapy access to patients. For more information on Phil, visit phil.us.

Contact Phil at: https://phil.us/manufacturers

i Impel Neuropharma. (2020). INP104-301. Table 3.8.2.

SOURCE Phil Inc.