Latest news with #CGRP
Malaysian Reserve
21-05-2025
- Health
- Malaysian Reserve
Migraine Market Enters New Era Following Satsuma Pharmaceuticals' ATZUMI and Amneal Pharmaceuticals' BREKIYA Regulatory Approval
The approval of ATZUMI and BREKIYA is expected to significantly reshape the migraine market by introducing new, innovative treatment options. These therapies promise improved efficacy and convenience, potentially capturing a substantial share from existing CGRP inhibitors. Their entry may intensify competition, drive pricing adjustments, and stimulate further innovation. LAS VEGAS, May 21, 2025 /PRNewswire/ — Migraine is recognized globally as the seventh most disabling condition across all diseases, accounting for approximately 2.9% of all years lived with disability (YLDs). It is also the top cause of disability among neurological disorders. Despite its prevalence, migraine is often underdiagnosed and undertreated. Around 50% of sufferers go undiagnosed, and fewer than half seek medical consultation. In 2024, the estimated number of individuals living with migraine in the 7MM reached roughly 119 million. Current migraine management involves a dual approach—acute treatment to relieve symptoms during an attack, and preventive strategies to reduce the frequency and intensity of future episodes. Acute therapies generally include triptans, nonsteroidal anti-inflammatory drugs (NSAIDs), and anti-nausea medications, which target symptoms like pain and nausea. Recently, more focus has been placed on preventive care for patients with frequent or debilitating migraines. This includes the use of medications such as beta-blockers, antiepileptic drugs, and CGRP (calcitonin gene-related peptide) inhibitors, along with lifestyle changes to identify and avoid migraine triggers. Preventive or prophylactic treatments aim to decrease the frequency, severity, and duration of migraine attacks, as previously discussed. FDA-approved preventive agents include propranolol, timolol, divalproex sodium, OnabotulinumtoxinA (Botox), and topiramate. While other migraine medications have demonstrated efficacy, they lack formal FDA approval for migraine prevention. For forecasting purposes, these therapies are grouped into classes such as antiepileptics, antihypertensives, and neurotoxins. Notably, Botox stands out as the only FDA-approved non-daily injectable option for chronic migraine, offering fewer side effects compared to daily oral medications. Learn more about the migraine therapeutic market @ Migraine Treatment Market Eptinezumab (ALD-403), marketed as VYEPTI, is approved for the preventive treatment of migraines in adults. Aimovig, developed by Amgen and Novartis, was the first FDA-approved migraine prevention therapy from a new drug class that blocks CGRP, a key molecule involved in migraine episodes. FDA approved EMGALITY in September 2019 for preventing migraine in adults, but it's contraindicated for those hypersensitive to galcanezumab-gnlm or its components. In November 2019, the EU approved galcanezumab for adults with ≥4 migraine days/month. In September 2019, the FDA sanctioned AJOVY for adult migraine prevention. By January 2020, an autoinjector for Fremanezumab received FDA approval. In March 2019, AJOVY earned European Commission approval for adult migraine prophylaxis. Teva's AJOVY gained approval in Japan in June 2021. In September 2021, Impel Pharmaceuticals gained FDA approval for TRUDHESA, a nasal spray formulation of dihydroergotamine mesylate (0.725 mg per spray), intended for the acute treatment of migraines with or without aura in adults. In March 2023, Pfizer's ZAVZPRET (zavegepant) received FDA approval. It is the first CGRP receptor antagonist nasal spray approved for acute migraine treatment in adults, with or without aura, and uniquely utilizes Precision Olfactory Delivery (POD) technology, targeting the upper nasal cavity for drug delivery. The FDA also approved QULIPTA (atogepant) in April 2023 for chronic migraine prevention in adults. It stands out as the first oral CGRP receptor antagonist approved for both episodic and chronic migraine prevention. In the same month, IntelGenx Corp announced FDA approval of RIZAFILM, designed for the acute treatment of migraines. Additionally, in January 2025, the FDA approved AXS-07, an oral multi-mechanistic treatment for acute migraine attacks, developed by Axsome Therapeutics. Branded as SYMBRAVO, it is expected to launch in the U.S. approximately four months after FDA acceptance of the company's NDA resubmission in September 2024. Dive deep into the United States migraine drugs market @ Migraine Headache Drugs Market On April 30, 2025, the FDA approved ATZUMI, a nasal powder formulation of dihydroergotamine (DHE), developed by Satsuma Pharmaceuticals, for the acute treatment of migraines in adults. Satsuma is a subsidiary of Shin Nippon Biomedical Laboratories. ATZUMI is a drug-device combination that uses Satsuma's proprietary Simple MucoAdhesive Release Technology (SMART) platform. The medication is administered through a squeezable device inserted into the nostril, delivering DHE in powder form. The FDA had previously rejected ATZUMI's marketing application last year, citing concerns related to chemistry, manufacturing, and controls. However, no issues were raised about the clinical data, nor were additional trials requested. The recent approval was supported by results from a Phase I pharmacokinetics study and the Phase III ASCEND trial. These trials showed that ATZUMI is rapidly absorbed, maintains high and sustained DHE plasma levels, and is safe for individuals with migraines. Over one-third of patients experienced pain relief within two hours of use. Recently, in May 2025, Amneal Pharmaceuticals, Inc. announced that the FDA had approved BREKIYA (dihydroergotamine mesylate) injection, the first and only autoinjector form of dihydroergotamine (DHE) for the acute treatment of migraine with or without aura, as well as cluster headaches in adults. The product is expected to become available to eligible patients in the second half of 2025. The BREKIYA autoinjector offers the possibility of sustained pain relief† in a convenient, self-administered format. It delivers the same DHE medication traditionally used in hospital settings but in a prefilled, ready-to-use device. The autoinjector does not require refrigeration, assembly, or priming, and is designed for subcutaneous injection into the middle of the thigh. This delivery method may be especially useful for patients who have a poor response to oral medications, experience nausea or vomiting during migraine attacks, have delayed gastric emptying, or tend to postpone treatment until symptoms have worsened. To know more about the migraine treatment devices, visit @ Migraine Treatment Devices Market Although standardized treatment guidelines are widely available and a range of mostly affordable options for both acute and preventive migraine therapies exist, there remains a significant unmet need, contrary to common belief. Many of the currently used treatments are not universally effective, may pose cardiovascular risks for some patients, and are either too general or poorly tolerated. Response rates remain suboptimal, breakthrough migraines are frequent, and patients often rely on multiple medications to manage symptoms. Additionally, side effects contribute to poor compliance and adherence. Studies indicate that about half of patients are dissatisfied with the ability of their current therapy to prevent recurring pain, and nearly 80% are open to trying new acute or preventive options. Looking ahead, the migraine treatment landscape is poised for major transformation, driven by shifts in market dynamics that began around 2020. Advances in novel drug development and biomarker-based targeting are expected to significantly enhance revenue potential across the 7MM during the forecast period of 2025 to 2034. Some of the migraine drugs in the pipeline include ABP-450 (Axsome Therapeutics), Aimovig (AEON Biopharma, Inc.), Lu AG09222 (Lundbeck), and others. Discover which therapies are expected to grab major migraine therapeutics market share @ Migraine Drugs Market ABP-450, developed by AEON Biopharma, Inc., is an injectable formulation containing a 900 kDa botulinum toxin type-A complex derived from Clostridium botulinum. At therapeutic doses, it induces chemical denervation of muscles, leading to a localized decrease in muscle activity. The drug is currently undergoing Phase II clinical trials for the treatment of episodic and chronic migraine. Aimovig, produced by Amgen, is a monoclonal antibody that targets and blocks the calcitonin gene-related peptide receptor (CGRP-R). Already approved for preventive migraine treatment, it is now being evaluated for migraine prevention in pediatric patients, covering both episodic and chronic forms. Lu AG09222, an investigational monoclonal antibody from Lundbeck, is designed to bind to and inhibit pituitary adenylate cyclase-activating polypeptide (PACAP). PACAP is a neuropeptide involved in migraine pathophysiology, making it a promising novel target. Lu AG09222 is being explored as a preventive therapy for individuals suffering from migraine. Discover more about migraine drugs in development @ Migraine Clinical Trials The anticipated launch of these emerging migraine treatments are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the migraine market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the migraine market size in the 7MM is expected to grow from USD 10.8 billion in 2023 at a significant CAGR by 2034. This expansion across the 7MM will be due to the rising awareness of the disease and incremental healthcare spending across the world, which would expand the migraine market size to enable the drug manufacturers to penetrate more into the migraine market. DelveInsight's latest published market report titled Migraine Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the migraine country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The migraine market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Prevalent Cases of Migraine Gender-specific Prevalent Cases of Migraine Severity-specific Prevalent Cases of Migraine Diagnosed Cases of Episodic and Chronic Migraine The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM migraine market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this migraine market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the migraine market. Also, stay abreast of the mitigating factors to improve your market position in the migraine therapeutic space. Related Reports Migraine Epidemiology Forecast Migraine Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted migraine epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Migraine Pipeline Migraine Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key migraine companies, including Satsuma Pharmaceuticals, Biohaven Pharmaceuticals, Allodynic Therapeutics, Vaxxinity, AbbVie, Pulmatrix, AEON Biopharma, Eli Lilly and Company, Trevena, Xoc Pharmaceuticals, Pharmaleads, Pear Therapeutics, among others. Cluster Headache Market Cluster Headache Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key cluster headache companies including Novartis AG, Zosano Pharma, Eli Lilly and Company, AstraZeneca Plc., Autonomic Technologies, Inc., ElectroCore Medical LLC., GlaxoSmithKline Plc, Winston Pharmaceuticals Inc., Lundback Seattle BioPharmaceutical, among others. Cluster Headache Pipeline Cluster Headache Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key cluster headache companies, including Lundbeck, Eli Lilly, AstraZeneca, GlaxoSmithKline, Zosano Pharma, GlaxoSmithKline, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact Us Shruti Thakurinfo@ +14699457679 Logo: View original content:
Yahoo
21-05-2025
- Health
- Yahoo
Migraine Market Enters New Era Following Satsuma Pharmaceuticals' ATZUMI and Amneal Pharmaceuticals' BREKIYA Regulatory Approval
The approval of ATZUMI and BREKIYA is expected to significantly reshape the migraine market by introducing new, innovative treatment options. These therapies promise improved efficacy and convenience, potentially capturing a substantial share from existing CGRP inhibitors. Their entry may intensify competition, drive pricing adjustments, and stimulate further innovation. LAS VEGAS, May 21, 2025 /PRNewswire/ -- Migraine is recognized globally as the seventh most disabling condition across all diseases, accounting for approximately 2.9% of all years lived with disability (YLDs). It is also the top cause of disability among neurological disorders. Despite its prevalence, migraine is often underdiagnosed and undertreated. Around 50% of sufferers go undiagnosed, and fewer than half seek medical consultation. In 2024, the estimated number of individuals living with migraine in the 7MM reached roughly 119 million. Current migraine management involves a dual approach—acute treatment to relieve symptoms during an attack, and preventive strategies to reduce the frequency and intensity of future episodes. Acute therapies generally include triptans, nonsteroidal anti-inflammatory drugs (NSAIDs), and anti-nausea medications, which target symptoms like pain and nausea. Recently, more focus has been placed on preventive care for patients with frequent or debilitating migraines. This includes the use of medications such as beta-blockers, antiepileptic drugs, and CGRP (calcitonin gene-related peptide) inhibitors, along with lifestyle changes to identify and avoid migraine triggers. Preventive or prophylactic treatments aim to decrease the frequency, severity, and duration of migraine attacks, as previously discussed. FDA-approved preventive agents include propranolol, timolol, divalproex sodium, OnabotulinumtoxinA (Botox), and topiramate. While other migraine medications have demonstrated efficacy, they lack formal FDA approval for migraine prevention. For forecasting purposes, these therapies are grouped into classes such as antiepileptics, antihypertensives, and neurotoxins. Notably, Botox stands out as the only FDA-approved non-daily injectable option for chronic migraine, offering fewer side effects compared to daily oral medications. Learn more about the migraine therapeutic market @ Migraine Treatment Market Eptinezumab (ALD-403), marketed as VYEPTI, is approved for the preventive treatment of migraines in adults. Aimovig, developed by Amgen and Novartis, was the first FDA-approved migraine prevention therapy from a new drug class that blocks CGRP, a key molecule involved in migraine episodes. FDA approved EMGALITY in September 2019 for preventing migraine in adults, but it's contraindicated for those hypersensitive to galcanezumab-gnlm or its components. In November 2019, the EU approved galcanezumab for adults with ≥4 migraine days/month. In September 2019, the FDA sanctioned AJOVY for adult migraine prevention. By January 2020, an autoinjector for Fremanezumab received FDA approval. In March 2019, AJOVY earned European Commission approval for adult migraine prophylaxis. Teva's AJOVY gained approval in Japan in June 2021. In September 2021, Impel Pharmaceuticals gained FDA approval for TRUDHESA, a nasal spray formulation of dihydroergotamine mesylate (0.725 mg per spray), intended for the acute treatment of migraines with or without aura in adults. In March 2023, Pfizer's ZAVZPRET (zavegepant) received FDA approval. It is the first CGRP receptor antagonist nasal spray approved for acute migraine treatment in adults, with or without aura, and uniquely utilizes Precision Olfactory Delivery (POD) technology, targeting the upper nasal cavity for drug delivery. The FDA also approved QULIPTA (atogepant) in April 2023 for chronic migraine prevention in adults. It stands out as the first oral CGRP receptor antagonist approved for both episodic and chronic migraine prevention. In the same month, IntelGenx Corp announced FDA approval of RIZAFILM, designed for the acute treatment of migraines. Additionally, in January 2025, the FDA approved AXS-07, an oral multi-mechanistic treatment for acute migraine attacks, developed by Axsome Therapeutics. Branded as SYMBRAVO, it is expected to launch in the U.S. approximately four months after FDA acceptance of the company's NDA resubmission in September 2024. Dive deep into the United States migraine drugs market @ Migraine Headache Drugs Market On April 30, 2025, the FDA approved ATZUMI, a nasal powder formulation of dihydroergotamine (DHE), developed by Satsuma Pharmaceuticals, for the acute treatment of migraines in adults. Satsuma is a subsidiary of Shin Nippon Biomedical Laboratories. ATZUMI is a drug-device combination that uses Satsuma's proprietary Simple MucoAdhesive Release Technology (SMART) platform. The medication is administered through a squeezable device inserted into the nostril, delivering DHE in powder form. The FDA had previously rejected ATZUMI's marketing application last year, citing concerns related to chemistry, manufacturing, and controls. However, no issues were raised about the clinical data, nor were additional trials requested. The recent approval was supported by results from a Phase I pharmacokinetics study and the Phase III ASCEND trial. These trials showed that ATZUMI is rapidly absorbed, maintains high and sustained DHE plasma levels, and is safe for individuals with migraines. Over one-third of patients experienced pain relief within two hours of use. Recently, in May 2025, Amneal Pharmaceuticals, Inc. announced that the FDA had approved BREKIYA (dihydroergotamine mesylate) injection, the first and only autoinjector form of dihydroergotamine (DHE) for the acute treatment of migraine with or without aura, as well as cluster headaches in adults. The product is expected to become available to eligible patients in the second half of 2025. The BREKIYA autoinjector offers the possibility of sustained pain relief† in a convenient, self-administered format. It delivers the same DHE medication traditionally used in hospital settings but in a prefilled, ready-to-use device. The autoinjector does not require refrigeration, assembly, or priming, and is designed for subcutaneous injection into the middle of the thigh. This delivery method may be especially useful for patients who have a poor response to oral medications, experience nausea or vomiting during migraine attacks, have delayed gastric emptying, or tend to postpone treatment until symptoms have worsened. To know more about the migraine treatment devices, visit @ Migraine Treatment Devices Market Although standardized treatment guidelines are widely available and a range of mostly affordable options for both acute and preventive migraine therapies exist, there remains a significant unmet need, contrary to common belief. Many of the currently used treatments are not universally effective, may pose cardiovascular risks for some patients, and are either too general or poorly tolerated. Response rates remain suboptimal, breakthrough migraines are frequent, and patients often rely on multiple medications to manage symptoms. Additionally, side effects contribute to poor compliance and adherence. Studies indicate that about half of patients are dissatisfied with the ability of their current therapy to prevent recurring pain, and nearly 80% are open to trying new acute or preventive options. Looking ahead, the migraine treatment landscape is poised for major transformation, driven by shifts in market dynamics that began around 2020. Advances in novel drug development and biomarker-based targeting are expected to significantly enhance revenue potential across the 7MM during the forecast period of 2025 to 2034. Some of the migraine drugs in the pipeline include ABP-450 (Axsome Therapeutics), Aimovig (AEON Biopharma, Inc.), Lu AG09222 (Lundbeck), and others. Discover which therapies are expected to grab major migraine therapeutics market share @ Migraine Drugs Market ABP-450, developed by AEON Biopharma, Inc., is an injectable formulation containing a 900 kDa botulinum toxin type-A complex derived from Clostridium botulinum. At therapeutic doses, it induces chemical denervation of muscles, leading to a localized decrease in muscle activity. The drug is currently undergoing Phase II clinical trials for the treatment of episodic and chronic migraine. Aimovig, produced by Amgen, is a monoclonal antibody that targets and blocks the calcitonin gene-related peptide receptor (CGRP-R). Already approved for preventive migraine treatment, it is now being evaluated for migraine prevention in pediatric patients, covering both episodic and chronic forms. Lu AG09222, an investigational monoclonal antibody from Lundbeck, is designed to bind to and inhibit pituitary adenylate cyclase-activating polypeptide (PACAP). PACAP is a neuropeptide involved in migraine pathophysiology, making it a promising novel target. Lu AG09222 is being explored as a preventive therapy for individuals suffering from migraine. Discover more about migraine drugs in development @ Migraine Clinical Trials The anticipated launch of these emerging migraine treatments are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the migraine market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the migraine market size in the 7MM is expected to grow from USD 10.8 billion in 2023 at a significant CAGR by 2034. This expansion across the 7MM will be due to the rising awareness of the disease and incremental healthcare spending across the world, which would expand the migraine market size to enable the drug manufacturers to penetrate more into the migraine market. DelveInsight's latest published market report titled Migraine Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the migraine country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The migraine market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Prevalent Cases of Migraine Gender-specific Prevalent Cases of Migraine Severity-specific Prevalent Cases of Migraine Diagnosed Cases of Episodic and Chronic Migraine The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM migraine market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this migraine market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the migraine market. Also, stay abreast of the mitigating factors to improve your market position in the migraine therapeutic space. Related Reports Migraine Epidemiology Forecast Migraine Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted migraine epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Migraine Pipeline Migraine Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key migraine companies, including Satsuma Pharmaceuticals, Biohaven Pharmaceuticals, Allodynic Therapeutics, Vaxxinity, AbbVie, Pulmatrix, AEON Biopharma, Eli Lilly and Company, Trevena, Xoc Pharmaceuticals, Pharmaleads, Pear Therapeutics, among others. Cluster Headache Market Cluster Headache Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key cluster headache companies including Novartis AG, Zosano Pharma, Eli Lilly and Company, AstraZeneca Plc., Autonomic Technologies, Inc., ElectroCore Medical LLC., GlaxoSmithKline Plc, Winston Pharmaceuticals Inc., Lundback Seattle BioPharmaceutical, among others. Cluster Headache Pipeline Cluster Headache Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key cluster headache companies, including Lundbeck, Eli Lilly, AstraZeneca, GlaxoSmithKline, Zosano Pharma, GlaxoSmithKline, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact Us Shruti Thakurinfo@ +14699457679 Logo: View original content: SOURCE DelveInsight Business Research, LLP Sign in to access your portfolio
Medscape
13-05-2025
- Health
- Medscape
Ubrogepant Eases Prodromal Migraine Symptoms
The clinical utility of the calcitonin gene–related peptide (CGRP) receptor antagonist ubrogepant may extend beyond the treatment of acute migraine to alleviating common prodromal symptoms of migraine, according to an exploratory analysis from the phase 3 PRODROME trial. Taken during the prodromal phase of migraine, ubrogepant led to improvements in concentration, as well as reduced sensitivity to light and sound, neck pain, fatigue, and dizziness — with some improvements occurring as soon as 1 hour after dosing. Ubrogepant (Ubrelvy) was approved in the United States for the acute treatment of migraine with, or without, aura in adults in 2019. It is not indicated for migraine prevention. The new data suggest ubrogepant administered in the premonitory (prodromal) phase of migraine, before a headache starts, may help resolve common prodromal symptoms, such as photophobia, phonophobia, and cognitive dysfunction. Led by Peter Goadsby, MBBS, MD, PhD, professor of neurology, King's College London, London, England, the study was published online on May 12 in Nature Medicine . Clinically Relevant Data The PRODROME trial enrolled 438 adults with at least 1-year history of migraine who could identify prodromal symptoms predictive of a headache within 1-6 hours. Each participant took a 100-mg dose of ubrogepant or placebo during one prodromal event, followed by the alternate treatment during a second prodromal event at least 7 days later. After dosing, ubrogepant was more effective than placebo on the outcomes of absence of photophobia at 2 hours (19.5% vs 12.5%; odds ratio [OR], 1.72), fatigue at 3 hours (27.3% vs 16.8%; OR, 1.85), neck pain at 3 hours (28.9% vs 15.9%; OR, 2.04), phonophobia at 4 hours (50.7% vs 35.8%; OR, 1.97), and dizziness at 24 hours (88.5% vs 82.3%; OR, 1.82). Ubrogepant was also better than placebo in terms of absence of difficulty concentrating at 1 hour (8.7% vs 2.1%; OR, 4.26) and difficulty thinking at 6 hours (56.9% vs 41.8%; OR, 2.05). Treatment-emergent adverse events were mild and slightly more common in the ubrogepant group (17% vs 12%). The authors noted that 32%-57% of premonitory symptoms were moderate to severe in intensity and associated with functional disability. 'As premonitory symptoms can be disabling, their treatment alone is clinically relevant, beyond the consideration that treatment during the prodrome prevents headache onset and improves function over 24-48 hours, as demonstrated in the primary analysis of the study,' the investigators wrote. 'Greater awareness of the clinical symptomatology of the prodromal phase, as well as the availability of effective treatment, offers a major opportunity to improve the treatment of acute migraine,' they concluded.
Yahoo
12-05-2025
- Health
- Yahoo
This Drug Reduces Symptoms Before a Migraine Strikes, Study Shows
A migraine drug called ubrogepant doesn't just reduce the severity of a migraine attack – it also dials down the non-headache symptoms in the prodrome: the hours leading up to the main event. That's the conclusion reached after a large clinical trial tested hundreds of migraine patients taking the medication at the onset of prodrome symptoms. The result suggests that ubrogepant might be effective for treating the entire migraine as it evolves, rather than just the head pain – and narrows down the mechanisms behind the condition. Migraine is a neurological affliction that affects an estimated 14 to 15 percent of the global population, yet it remains poorly understood, and difficult to treat effectively. It's known for its searing, debilitating head pain, but the anatomy of a migraine is much more complex and longer-lasting than just the head pain. Broadly, a migraine consists of three to four stages: the prodrome, during which the patient experiences symptoms such as light sensitivity, nausea, neck pain, and brain fog; aura, characterized by vision disturbances, including blind spots and flashing lights; the headache attack itself; and the postdrome, characterized by brain fog and fatigue. Put together, this sequence of events can last up to more than a week. It's quite unpleasant. Most treatments focus on the headache portion, since it's the most debilitating. Even studies on treatments designed to be taken during the prodrome phase have concentrated on blocking the headache, rather than treating the prodrome itself. Led by neurologist Peter Goadsby of Kings College London, a team of researchers has now conducted a trial on whether or not ubrogepant, a migtainte treatment available in the US under the brand name Ubrelvy, also works on the prodrome. Scientists want to know not just how to treat the entirety of a migraine – although that's a desired goal – but to help determine what drives a migraine attack. "It has long been argued whether migraine is primarily a disease of the brain or of peripheral, specifically vascular, origin," the researchers write in their paper. "The new data firmly support a brain origin for migraine attacks." Ubrogepant is a drug that does not prevent migraine attacks, but reduces the severity of the pain associated with an attack. It belongs to a class of drugs called calcitonin gene-related peptide (CGRP) receptor antagonists. Ubrogepant, and other drugs belonging to the same class, block the action of CGRP, a peptide associated with migraine. Goadsby and his colleagues recruited hundreds of migraine patients for a double-blind study. The 438 study participants, aged between 18 and 75, and all with at least a one-year history of migraine, were put in groups. One group was given ubrogepant at the onset of prodrome symptoms; the other was given a placebo. Then, during a second event at least seven days later, the groups switched. The patients initially given the drug were given the placebo, and vice versa. Neither the researchers nor the participants knew which group was receiving which. After taking the drug or the placebo, the participants were tasked with reporting changes in their symptoms, which included photo- and phonophobia, dizziness, fatigue, neck pain or stiffness, and brain fog. The patients taking the drug experienced a significantly higher reduction in their symptoms than the patients taking the placebo. One hour after taking ubrogepant, patients reported brain fog easing. After two hours, photophobia, or sensitivity to light, decreased. After three hours, neck problems eased. Between four and 24 hours after taking the drug, phonophobia (sensitivity to sound) and dizziness lessened, too. These results suggest that CGRP receptor antagonists might be effective at treating prodromal migraine symptoms, the researchers say. "As premonitory symptoms can be disabling, their treatment alone is clinically relevant, beyond the consideration that treatment during the prodrome prevents headache onset and improves function over 24 to 48 hours, as demonstrated in the primary analysis of the study," the researchers write. In addition: "Broadly, the findings of the clinical trial support imaging studies that have identified central nervous system sites as the locus of initiation of a migraine attack." There are several routes forward from here. The study didn't look at the effects of ubrogepant on the aura and postdrome phases of migraine, which could warrant further investigation. Future work could also probe further to try and narrow down the cause of migraine, and determine whether CGRP receptor antagonists might offer relief for the entire course of a migraine event. The research has been published in Nature Medicine. Shingles Vaccine Can Reduce Risk of Stroke And Heart Attack, Study Finds Spikes of Bird Flu in Cats Could Be a Warning of a Future Pandemic HIV Drugs Dramatically Lower Risk of Alzheimer's Disease, Study Finds
Business Journals
07-05-2025
- Health
- Business Journals
For migraine patients, specialized center at Cleveland Clinic provides advanced, holistic care
Never miss an episode of Florida Health Care Insider presented by Cleveland Clinic in Florida. Subscribe now on Apple Podcasts, Spotify or wherever you get your podcasts. There are headaches. And then, for almost 40 million Americans, there are migraines. 'A migraine is more than just a simple or even a bad headache. For some people, it can be a debilitating neurological dysfunction that can significantly impact daily life,' says Anam Baig, MD, a neurologist with the Headache and Facial Pain Center at Cleveland Clinic Weston Hospital. In this episode of the Florida Health Care Insider podcast, presented by Cleveland Clinic in Florida in partnership with the South Florida Business Journal, Dr. Baig discusses migraines' myriad causes and symptoms, and existing and potential future remedies. Dr. Baig says one of the most exciting recent developments for treating migraines is Calcitonin Gene-Related Peptide (CGRP) inhibitors. These medications block the effect of the CGRP molecule, one factor that causes migraines. Botox injections are another option that Dr. Baig says can be highly effective for some people. Before any treatment is administered, patients undergo detailed, individualized evaluations to uncover potential causes or 'triggers' and their unique symptoms - and then determine treatment plans. 'Our number-one goal is to create a holistic treatment plan that fits the patient and delivers the relief they're seeking,' Dr. Baig says. Listen to this episode to hear about: Some surprising migraine triggers (4:40) The latest medical treatments (9:15) Feedback from patients at the Headache and Facial Pain Center (13:30) Learn more here about the Headache and Pain Facial Center at Cleveland Clinic Weston Hospital. Disclaimer This podcast is for general informational purposes only and does not constitute the practice of medicine or any professional health care services. The information provided is not intended to create, and the receipt of it does not constitute, a health care provider-patient relationship. This podcast is not intended to be a substitute for any professional advice or medical advice, examination, diagnosis or treatment. Please consult a licensed medical professional before undertaking any form of medical treatment, exercise program, or dietary guidelines. If you think you may be experiencing a medical emergency, you should call a physician or 911 immediately. It is neither a legal interpretation nor a statement of Cleveland Clinic Florida Regional Health System or the South Florida Business Journal policy. Reference to any specific product or entity does not constitute an endorsement or recommendation by Cleveland Clinic Florida Regional Health System or the South Florida Business Journal. This podcast is provided as a courtesy, and we cannot guarantee that it is completely accurate or error-free. You assume all risk arising from the content of this podcast and Cleveland Clinic Florida Regional Health System or the South Florida Business Journal disclaim any liabilities to any parties.
