SCHAUMBURG, Ill., Sept. 28, 2021 /PRNewswire/ -- Carepoint Pharmacy announces that it will partner with Impel NeuroPharma, Inc. (NASDAQ: IMPL) to begin dispensing Trudhesa™ (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in adults. Trudhesa, approved by the U.S. Food and Drug Administration (FDA) on September 2, 2021, uses Impel's proprietary Precision Olfactory Delivery (POD®) technology to gently deliver 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 rapid, sustained, and consistent symptom relief without injection or infusion, even when administered hours after the onset of a migraine attack.
Carepoint Pharmacy's unique end-to-end digital pharmacy solutions will support people with migraine throughout the country through this partnership. Carepoint Pharmacy is only one of two digital pharmacies selected to dispense Trudhesa as part of a limited distribution network.
"Our company was built to provide patients with a simple and patient-first pharmacy experience that makes getting prescriptions easy, fast and reliable. When you're dealing with the unpredictability of a condition like migraine, we offer assurance that your medication will arrive quickly, straight to your home, for convenience you can trust," said Bhavesh Patel, PharmD, Chief Executive Officer, Carepoint Pharmacy.
"At Impel, the needs of patients drive our quest to innovate and when we seek our partners, we look for those who put patients first," said Adrian Adams, Chairman and Chief Executive Officer, Impel NeuroPharma. "Today, we are thrilled to partner with Carepoint Pharmacy to make Trudhesa available to people with migraine via Trudhesa Direct™, providing an option that offers the rapid, sustained, and consistent relief they are looking for. Eligible, commercially-insured patients are automatically enrolled in a savings program and the medication is shipped straight to their home at no additional cost. Together with Carepoint Pharmacy, we look forward to providing an unparalleled experience for people with migraine who choose Trudhesa for symptom relief."
Trudhesa Indication and Important Safety Information
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.
Imple, POD, Trudhesa, and Trudhesa Direct are trademarks of Impel NeuroPharma, Inc. To learn more about Impel NeuroPharma, please visit https://impelnp.com/.
About Carepoint Pharmacy
Carepoint Pharmacy is a full-service, digital pharmacy that offers prescription fulfillment and delivery to patients in all 50 states and Washington D.C. With six owned and operated pharmacies, Carepoint's accreditations include URAC Mail Order Pharmacy, URAC Specialty Pharmacy, and NABP Digital Pharmacy. To learn more about Carepoint Pharmacy, please visit https://carepoint.pharmacy/.
SOURCE Carepoint Pharmacy