September 3, 2021 – Golisano Children’s Hospital’s Mobile Pediatric Vaccination Clinic will be making stops around Southwest Florida next week to vaccinate children 12 years-old and older for COVID-19.

The Mobile Pediatric Vaccination Clinic is walk-up only, and there is no cost for the COVID-19 vaccine, which will be Pfizer. 

The mobile clinic will be at the following locations next week:

  • Tuesday, Sept. 7, 11 a.m.-2 p.m., Bob Janes Triage Center, 2789 Ortiz Ave., Fort Myers
  • Tuesday, Sept. 7, 4-6:30 p.m., Suncoast Estates, 2241 Case Lane, North Fort Myers
  • Wednesday, Sept. 8, 3-5 p.m., Hector A. Cafferata, Jr. Elementary School, 250 Santa Barbara Blvd. N., Cape Coral
  • Thursday, Sept. 9, 4:30-6:30 p.m., Spring Creek Elementary School, 25571 Elementary Way, Bonita Springs
  • Friday, Sept. 10, noon-4 p.m., Pink Shell Beach Resort, 275 Estero Blvd, Fort Myers Beach *This stop is primarily for 2nd doses, however, 1st doses will be provided to those who would like them. Anyone who receives a 1st dose at this location may have to attend another site for their 2nd dose.
  • Saturday, Sept. 11, 9 a.m.-noon, Utopia Unisex Salon, 3071 Dr. Martin Luther King Jr. Blvd., Fort Myers

A parent or authorized guardian must accompany a minor for vaccination. The second dose will be set for the same location or one nearby.

Anyone 12 years old and older can also receive their COVID-19 vaccine at no cost at Lee Health’s Community Vaccination Clinic, located at Gulf Coast Medical Center. For more information, visit www.leehealth.org.

About Lee Health

Since the opening of the first hospital in 1916, Lee Health has been a health care leader in Southwest Florida, constantly evolving to meet the needs of the community. A non-profit, integrated health care services organization, Lee Health is committed to the well-being of every individual served, focused on healthy living and maintaining good health. Staffed by caring people, inspiring health, services are conveniently located throughout the community in four acute care hospitals, two specialty hospitals, outpatient centers, walk-in medical centers, primary care and specialty physician practices and other services across the continuum of care. Learn more at www.LeeHealth.org. 



September 3 2021 – The National Institutes of Health is awarding seven projects a total of $18.15 million over five years to a new effort focused on interoception—the ways in which organisms sense and regulate signals within their bodies. Interoception is not well understood and is a new area of research focus for NIH. This coordinated effort, which involves multiple NIH Institutes and Centers, will address critical knowledge gaps and challenges in understanding interoception that are not tackled by other major NIH research initiatives.

The interoception research effort is part of NIH’s Blueprint for Neuroscience Research, and the seven studies receiving grants are expected to advance researchers’ understanding of nervous system function and disorders and the role of interoception in human health.

“Dysfunctions in interoception may play important roles in many neurological, psychiatric, and behavioral disorders,” said Helene Langevin, M.D., director of NIH’s National Center for Complementary and Integrative Health (NCCIH). “Gaining a better understanding of how interoception works may help us develop better ways to treat these conditions.”

The Blueprint for Neuroscience Research is a collaborative framework through which 14 NIH Institutes, Centers, and Offices, including NCCIH, jointly support research on the nervous system. The seven projects funded through this award will study the neural circuits involved in functional communication between organ systems and the brain for processes such as digestion, metabolism, and breathing in experimental model systems. They will also seek to understand the health consequences of disrupting signals between the brain and these organ systems.

“Research is needed to understand how a host of bodily functions interact with our neural circuits to determine ‘how we feel,’ and how neural activity automatically modulates critical body functions on a continuous basis. Understanding the integration of neural systems with our bodies may lead to treatment for a host of illnesses, and help many to ‘feel better’,” said Walter Koroshetz, M.D., director of the National Institute on Neurological Disorders and Stroke (NINDS).

The seven projects funded by the Blueprint for Neuroscience Research are:

  • Functional Neural Circuits of Stomach-Brain Interoception; University of Michigan at Ann Arbor, Ann Arbor, Michigan: Zhongming Liu, Ph.D. and Jiande Chen, Ph.D. This project will map the two-way communication pathways between the brain and the stomach. It will also examine how nutrients and other stomach stimuli affect brain activity as well as study the regions of the brain that send signals to control gastric function. (Grant # R01 AT011665-01)
  • Dissecting the Interoception Circuit That Controls Airway Constriction; University of California, San Diego, La Jolla, California: Xin Sun, Ph.D. This project will map the neural circuits by which signals travel between the lungs and the brain when an allergen is detected. It also seeks to determine which neurons are activated by signals in the peripheral ganglia and brain regions including the nucleus of the solitary tract, among others. It will use various stimuli to assess gain and loss of lung function relating to key vagal, spinal, and brain connections. (Grant # R01 AT011676-01)
  • Metabolic Changes: Connecting Temperature Sensing Neurons to Sympathetic Adipose Tissue Stimulation; Louisiana State University Pennington Biomedical Research Center, Baton Rouge, Louisiana: Heike Muenzberg-Gruening, Ph.D. This project will investigate how the brain and adipose tissues communicate using the sympathetic nervous system to regulate leptin hormone levels. It will use cutting-edge techniques to identify new excitatory and inhibitory neural circuits to brown and white adipose tissue. It will also study how various physiological conditions—high versus low body temperature, fasting versus fed states—influence interactions between adipose tissues and areas of the brain involved in temperature control and taste perception. (Grant # R01 AT011683-01)
  • Functional Identification of Vagal Sensory Neurons Innervating the Liver; Albert Einstein College of Medicine, Bronx, New York: Young-Hwan Jo, Ph.D. This project will map the pathway through which the liver and the brain communicate using the sympathetic nervous system to regulate the body’s glucose production, metabolism, and control processes and direct other functions governed by the liver. It will also explore the potential effects of disruptions in this pathway. (Grant # R01 AT011653-01)
  • Dissecting Neural Circuits for Breathing Patterns; University of Michigan at Ann Arbor, Ann Arbor, Michigan: Peng Li, Ph.D. This project seeks to understand if brain stem neurons that express one of two peptides—gastrin-releasing peptide (Grp) or tachykinin 1 (Tac1)—are central in the control of two respiratory reflexes that protect the airways during breathing: sighing and coughing. It will also study brain circuit responses to signals associated with these reflexes. By identifying the cells and molecules involved in this signaling, the project expects to demonstrate how the brain processes interoceptive signals related to sighing and coughing. (Grant # R01 AT011652-01)
  • Unravelling Lung Interoception and Its Functional Consequence in the Developing Ovine Lung; Loma Linda University, Loma Linda, California: Arlin B. Blood, Ph.D. and Christopher G. Wilson, Ph.D. This project will investigate the role of intrinsic lung interoceptors and their circuits in the normal development of the lung and central respiratory networks. It will map the pulmonary interoceptor circuitry from the lung to the brain as well as explore the potential effects of disruptions in this pathway on lung structure and function during the fetal and newborn stages of life. (Grant # R01 AT011691-01)
  • Spinal Sensory Ganglia and Gut Sensation; Icahn School of Medicine at Mount Sinai, New York, New York: Ivan De Araujo, Ph.D. This project will study how the body uses sensory nerves in the spine to send signals to the lateral reticular nucleus area of the brain about changes in the gut such as distension. It will also investigate how stomach-spine-brain pathways influence brain circuits in the parietal cortex, insular cortex, and orbitofrontal cortex as well as functions such as the reward response in the brain. (Grant # R01 AT011697-01) 

“Interoceptive processes play important roles in a range of different cognitive and emotional behaviors. Basic research studies, such as those supported under the Blueprint Initiative, will provide the foundational anatomical and functional data needed to further our understanding of interoception, and to foster future studies focusing on how dysfunction in interoceptive pathways might contribute to mental illnesses and other brain disorders,” said Joshua A. Gordon, M.D., Ph.D., director of the National Institute of Mental Health.

Read more about the Blueprint for Neuroscience Research in the Trends in Neurosciences Editorial Special Issue: The Neuroscience of Interoception at https://www.cell.com/trends/neurosciences/fulltext/S0166-2236(20)30270-8(link is external).

About the Blueprint for Neuroscience Research: The Blueprint for Neuroscience Research is a collaborative framework through which 14 NIH Institutes, Centers, and Offices jointly support neuroscience-related research, with the aim of accelerating discoveries and reducing the burden of nervous system disorders. For more information about the Blueprint for Neuroscience Research and its funding and training opportunities, visit https://neuroscienceblueprint.nih.gov/.

About the National Center for Complementary and Integrative Health (NCCIH):
NCCIH’s mission is to define, through rigorous scientific investigation, the fundamental science, usefulness, and safety of complementary and integrative health approaches and their roles in improving health and health care. For additional information, call NCCIH’s Clearinghouse toll free at 1-888-644-6226. Follow us on Twitter(link is external), Facebook(link is external), and YouTube(link is external).

NINDS is the nation’s leading funder of research on the brain and nervous system. The mission of NINDS is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease.

About the National Institute of Mental Health (NIMH): The mission of the NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery and cure. For more information, visit the NIMH website.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.



September 3 2021 – Alternate Solutions Health Network (ASHN), an award-winning home health leader, recently formed a home health partnership that will expand and enhance home health services in South Florida under Memorial Healthcare System’s trusted brand. 

“Memorial Healthcare System has been providing home health services for more than 20 years and remains strong in its commitment to this service,” said Nina Beauchesne, Executive Vice President and Chief Transformation Officer, Memorial Healthcare System. “This newly created Home Health partnership will further elevate the home-health care experience, while delivering the top-level quality of service that consumers have come to expect from Memorial.”

As care models continue to evolve, the partnership between ASHN and Memorial will provide patients with a higher level of care coordination, enhanced communication and an overall patient experience when seeking and using these services. In addition, new job opportunities for nurses, therapists and home health aides will become available.

Alternate Solutions Health Network, based in Kettering, Ohio, is widely recognized as an industry leader in multidisciplinary post-acute care services. ASHN partners with health systems representing 90 hospitals across five states in joint venture partnerships to create post-acute care solutions.

“We are proud to partner with Memorial Healthcare System. Together we will expand high quality care in patients’ homes across South Florida,” said David Ganzsarto, Chief Executive Officer of ASHN. “Memorial has built a leading integrated care delivery model, and we are excited to support its continued success.”

About Alternate Solutions Health Network (ASHN)

ASHN was founded in 1999 and has been recognized as a National Homecare Elite Top 1% homecare agency based on outcomes and performance. It has also received Best Places to Work and Better Business Bureau Integrity Awards.

About Memorial Healthcare System

Memorial Healthcare System (www.mhs.net) is one of the largest public healthcare systems in the country and a national leader in quality care and patient satisfaction, highly regarded for its exceptional patient and family-centered care. Its facilities include Memorial Regional Hospital, Memorial Regional Hospital South, Joe DiMaggio Children’s Hospital, Memorial Hospital West, Memorial Hospital Miramar, Memorial Hospital Pembroke, and Memorial Manor nursing home. For more information, visit mhs.net.



Delray Medical Center Now Using RED 62 Reperfusion Catheter & BENCHMARK BMX96 for Stroke Patients

September 4 2021– Delray Medical Center reports that it is the first hospital in the state of Florida to use the RED 62™ Reperfusion Catheter & BENCHMARK BMX96™ for stroke patients.  Neurointerventionalist, Dr. Dennys Reyes, is the first doctor in the county to use this technology.   The RED 62™ is designed to navigate complex distal vessel anatomy and deliver powerful aspiration along with the BENCHMARK BMX96™ to remove blood clots in acute ischemic stroke patients with large vessel occlusions. In addition, it provides faster navigation and shorter times to recanalize “brain vessels”. 

“The RED 62™ is engineered with some of the latest innovations in tracking and aspiration technology to address large vessel blockages from a stroke located in more challenging areas, while maximizing powerful aspiration to remove blood clots,” said Dr. Reyes.  “With the help of the BENCHMARK BMX96™ Access System, hypotube technology provides a higher stability for more complex cases when it comes to treatment of a stroke.  In addition, when performing a procedure, the catheter is designed to increase versatility and visualization designed to help offer patients the best possible outcomes.”

As a comprehensive stroke center, Delray Medical Center has advanced technology and services to help with any neurological issues.  Our hospital is a member of the Advanced Neuroscience Network, and integrated delivery system of medical professionals and hospitals focused on offering a full continuum of neurological care throughout South Florida. 

“This new technology gives patients who come to our hospital for stroke care the latest in neurologic care,” said Maggie Gill, chief executive officer of the Palm Beach Health Network & Delray Medical Center.  “This hospital continues to be at the forefront when it comes to the newest medical care in our community, and the RED 62™ Reperfusion Catheter & BENCHMARK BMX96™ is no exception.”

For more information about our neurosciences program, go to www.delraymedicalctr.com or call 561-498-4440.

About Delray Medical Center

For nearly 40 years, Delray Medical Center, part of the Palm Beach Health Network, is a 523-bed acute care hospital, has served the communities of South Palm Beach County. As both a community hospital and state-designated Level I Trauma Center located on a 42-acre medical plaza, Delray Medical Center has the ability to offer several specialized services including cardiac care, orthopedics, rehabilitation, neurosciences, emergency care and more.

For the past 14 years, Delray Medical Center has been named one of America’s 50 Best Hospitals by Healthgrades®, a leading independent healthcare ratings organization. Delray Medical Center is a recipient of the Healthgrades 2020 Patient Safety Excellence Award, a designation recognizing superior performance of hospitals preventing the occurrence of serious, potentially avoidable complications for patients during hospital stays.  The hospital is also a Five-Star Recipient for Treatment of Heart Failure for 17 years in a row (2003-2019).

Delray Medical Center is a state-designated Comprehensive Stroke Center by the DNV-GL and received Get With The Guidelines award for advanced therapy for Thrombectomy. In addition, the hospital earned the Get With the Guidelines – Heart Failure and Stroke Gold Plus Quality Achievement Awards from the American Heart Association/American Stroke Association in 2020. Delray Medical Center was also named by Healthgrades as a Five-Star Recipient for Treatment of Stroke for 12 years in a row (2008-2020).  Pinecrest Rehabilitation and Outpatient Hospital at Delray Medical Center is a CARF accredited rehabilitation unit, and the only state designated brain and spinal cord injury rehabilitation program in Palm Beach County by the state of Florida, Department of Health.

Delray Medical Center is actively involved in community outreach, sponsoring several events, community lectures and fundraisers. The hospital is also a smoke-free campus. For more information or for a free physician referral, please call 1-800-897-9789 or visit the website at www.delraymedicalctr.com.



TRUDHESA Is the First and Only Therapeutic to Use POD technology to Deliver Dihydroergotamine Mesylate (DHE) to the Vascular-Rich Upper Nasal Space

TRUDHESA Is Well Tolerated and Delivers Rapid, Sustained and Consistent Symptom Relief for the Acute Treatment of Migraine

Commercial Launch of TRUDHESA is Planned for Early October 2021

Impel to Host Investor Call on Tuesday, September 7, 2021 at 8:30 a.m. ET

Sept. 03, 2021 – Impel NeuroPharma, Inc. (NASDAQ: IMPL), a commercial-stage biopharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs, with an initial focus on the central nervous system, today announced that the U.S. Food and Drug Administration (FDA) approved TRUDHESA™ (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in adults. TRUDHESA was previously known as INP104.

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.1 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.2 The Commercial launch of TRUDHESA is planned for early October 2021.

“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,” said Adrian Adams, Chairman and Chief Executive Officer of Impel NeuroPharma. “The approval of TRUDHESA marks the culmination of more than a decade of research and advanced engineering to pair the proven efficacy of DHE with our innovative POD technology. We are grateful for all the patients and investigators who participated in our clinical trials and who were instrumental in bringing this needed advancement to the migraine community.”

The New Drug Application for TRUDHESA included the results of the Phase 3, open-label, pivotal safety study, STOP 301, which is the largest longitudinal study ever conducted with DHE using nasal spray delivery.3 More than 5,650 migraine attacks were treated over 24 or 52 weeks during the study. The primary objective of the study was to assess the safety and tolerability of TRUDHESA. Exploratory objectives included efficacy assessments of migraine measures and a patient acceptability questionnaire. In the trial, TRUDHESA was generally well tolerated and exploratory efficacy findings showed it provided rapid, sustained, and consistent symptom relief. Unlike some oral acute treatments that need to be taken within one hour of attack onset to be most effective, STOP 301 reported TRUDHESA offered consistent efficacy even when taken late into a migraine attack.4

“Many of my patients need more from their migraine treatment, and TRUDHESA offers a non-oral, fast-acting, reliable option that overcomes many current medication challenges,” said Stephanie J. Nahas-Geiger, MD, MSEd, Associate Professor in the Department of Neurology, and Program Director of the Headache Medicine Fellowship Program, Thomas Jefferson University. “Its upper nasal delivery circumvents the GI tract and common phenomena associated with migraine, such as nausea and gastroparesis, that can impact the effectiveness of oral treatments. And, importantly, it is a self-administered, single dose that can be taken anytime during a migraine attack, so patients don’t need to worry about missing the opportunity to benefit from using TRUDHESA within a certain timeframe. I think patients will be very receptive to this treatment, because it pairs the long-proven benefits of DHE with a patient-friendly delivery system.”

There were no serious TRUDHESA-related treatment-emergent adverse events (TEAEs) observed in the STOP 301 study and the majority of TEAEs were mild and transient in nature.4 Some of the most frequently reported TRUDHESA-related TEAEs (≥2%) during the entire 52-week study period were nasal congestion (17.8%), nausea (6.8%), nasal discomfort (6.8%), abnormal olfactory test (6.8%) and vomiting (2.7%).5

In the STOP 301 study, patient-reported exploratory efficacy findings reported that more than a third of patients (38%) had pain freedom,6 two-thirds (66%) had pain relief,7 and more than half (52%) had freedom from their most bothersome migraine symptom8 at two hours after their first dose of TRUDHESA. For one in six patients (16%), pain relief started as early as 15 minutes.7 Of patients who were pain free at two hours, 93 percent were still pain free at 24 hours,11 and 86 percent were still pain free through two days.9 The great majority of patients (84%) reported that TRUDHESA was easy to use10 and preferred it over their current therapy.11

“Migraine is a disease that impacts the whole body and is the second leading cause of disability,”12 said Kevin Lenaburg, executive director, Coalition for Headache and Migraine Patients (CHAMP), which represents 12 national headache and migraine patient advocacy groups. “Historically there have not been enough effective treatments for treating migraine attacks, especially treatments that are not oral medicines, which can be challenging due to nausea, vomiting and other GI symptoms that can occur during a migraine. We welcome an important new treatment that combines the long-established efficacy of DHE with a non-oral, innovative delivery system that allows patients to self-administer wherever they are and at any point within a migraine attack.”

TRUDHESA will be available through Trudhesa™ Direct, a hassle-free pharmacy partnership and copay program. The digital pharmacy fulfilment partners, Phil Inc. and Carepoint Pharmacy, will provide electronic prescribing and automatic enrollment in the patient savings program for eligible, commercially insured patients without the need for a paper copay card. The pharmacy partners will provide a customized and seamless patient experience. Once the pharmacy receives the e-prescription, patients will be notified via digital communications that their prescription has been processed and receive their medication via convenient, free, home delivery. For more information, please visit, www.TRUDHESA.com.

Conference Call Information
Impel NeuroPharma will host a live conference call and webcast on Tuesday, September 7, 2021 at 8:30 a.m. ET to discuss the FDA’s approval of TRUDHESA. The conference call may be accessed by dialing 877-295-2648 (domestic) or 470-495-9487 (international) and referring to conference ID 4387746. A live webcast of the event will be available on the Investors section of the Impel NeuroPharma website at https://investors.impelnp.com/. A replay of the webcast will be available on the Impel NeuroPharma website following the event.

About Migraine and The Importance of Non-Oral Acute Treatment Options
Approximately 31 million adults in the U.S. are living with migraine,13,14 which is characterized by recurrent episodes of moderate to severe head pain and associated with nausea, vomiting and sensitivity to light and sound. Migraine is the second most common cause of disability in the world and the most common cause of disability among young women.14

In a 2017 survey of nearly 4,000 U.S. patients using oral acute prescription medication for migraine, 96 percent said they were dissatisfied with at least one aspect of their treatment—including lack of sustained relief, inconsistent relief, and lack of relief from a rapid-onset attack. Nearly half (48%) said they can still have pain two hours after taking medication and 38 percent say their headache returns within 24 hours of getting relief.15 

The high prevalence of related GI conditions among people with migraine may require alternative routes of medication delivery. Evidence suggests 80 percent of people with migraine experience gastroparesis, delayed emptying of the stomach, which may delay or reduce the absorption of oral medications.16,17 Additionally, more than 70 percent of people with migraine experience nausea and nearly 30 percent experience vomiting.3 The American Headache Society guidelines recommend a non-oral therapy for patients who have limited or no response to oral medicine.18

About TRUDHESATM (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 therapeutic19—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.20

TRUDHESA is a single use, drug-device combination product containing a vial of DHE (4 mg DHE in a 1 mL solution that is clear and colorless to faintly yellow) and a POD® device. Prior to initiation of TRUDHESA, a cardiovascular evaluation is recommended. For patients with risk factors predictive of coronary artery disease who are determined to have a satisfactory cardiovascular evaluation, it is strongly recommended that administration of the first dose of TRUDHESA take place in the setting of an appropriately equipped healthcare facility.

TRUDHESA is designed to be self-administered. Once assembled, TRUDHESA should be primed before initial use by releasing 4 sprays. A patient should use TRUDHESA immediately after priming. The recommended dose of TRUDHESA is 1.45 mg administered as two metered sprays into the nose (one spray of 0.725 mg into each nostril). The dose may be repeated, if needed, a minimum of 1 hour after the first dose. A patient should not use more than 2 doses of TRUDHESA within a 24-hour period or 3 doses within a 7-day period. A patient should use or discard TRUDHESA within 8 hours once the vial has been opened or the product has been assembled. A consumer assembly video is available on www.TRUDHESA.com.

The most common adverse reactions (incidence ≥2%) to TRUDHESA were nasal congestion, nasal discomfort, nausea, product taste abnormal, and product package associated injury. For more information about TRUDHESA and Full Prescribing Information, including BOXED WARNING, please visit, www.TRUDHESA.com.

About Dihydroergotamine Mesylate (DHE)
Dihydroergotamine Mesylate (DHE) was approved for the treatment of migraine in 194618 and has more than 70 years of therapeutic use.18 Migraine treatment with DHE has demonstrated efficacy independent of when the treatment is initiated.9 Unlike other available treatments for migraine, DHE is known to bind to multiple receptors theorized to be implicated in migraine onset and duration.9

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.