Latest news with #AmericanHeadacheSociety
Medscape
a day ago
- Health
- Medscape
A Review of Transnasal Cooling for Migraine Relief
Transnasal evaporative cooling as an acute treatment for migraine has been tested in two randomized clinical trials showing some level of efficacy and tolerability as well as safety. CALM1 Accrual Issues The first, CALM 1, was presented as a virtual poster at the 2023 American Headache Society meeting. Although this study enrolled 87 patients with migraine with or without aura, only 24 were randomized to the CoolStat Transnasal Thermal Regulating Device (CoolTech LLC). This comprised 15 minutes of air flow as soon as they arrived at their local testing center during an attack. CoolStat device in use The primary endpoint was pain relief at 2 hours; pain freedom, relief of most bothersome symptom, and tolerability were also measured at 2 and 24 hours. Three air flow rates were tested: 24, 18, and 6 liters per minute (LPM). It was originally assumed that the 6 LPM flow rate would act as the sham, but it turned out to be the most effective rate. In this group, 8 of 9 patients reported pain relief at 2 hours with 4 of them being pain free. Patients treated with the other doses reported a similar rate of pain relief, but none were fully free of pain at 2 hours. There were no adverse events in the lowest flow rate group and only mild events in the other groups. The study was terminated due to insufficient accrual rates. The company decided to do a second study with a smaller portable device which patients could use at home earlier in the course of their migraine attack. CALM 2 At Home Treatment The CALM 2 study used a 2 LPM dose as the sham: This used an inactive drying agent and patients experienced the sensation of treatment including saline mist. This small, phase 2, dose range-finding trial tested active doses of 4, 6, and 10 LPM. Patients treated their migraine for 15 minutes within 1 hour of pain onset using the Mi-Helper, an investigational device similar in size to a sleep apnea machine. The Mi-Helper The Mi-Helper No other treatment was allowed for 2 hours. Of the 172 adults randomized, 128 used the device and were included in the modified intention-to-treat analysis. Only 74 were included in the efficacy analysis because the others did not fully follow the protocol for a variety of reasons. In this study, the 10 LPM air flow rate was the most effective, producing pain freedom at 2 hours in 8 of 17 patients, vs 4 of 25 sham-treated patients. This difference was statistically significant. Two-hour pain relief was seen in 70.6% of this group vs 56% of the sham group, a difference that did not reach statistical significance. Sustained pain freedom from 2 to 24 hours with no rescue treatment was numerically but not significantly higher than sham with the 10 LPM dose. Results for the other air flow rates (4 and 6 LPM) were not statistically significant. The most common adverse events, scattered across the three active-treatment groups, were rhinorrhea, nasal irritation, ear pressure, nasal congestion, sore throat, and jaw pain. More events occurred in the 10 LPM group (with none in the sham group), but no patient discontinued the trial because of side effects. How Does it Work? The proposed mechanism of action for Mi-Helper, according to Steve Schaefer, the CEO of Cooltech, is that it 'noninvasively cools and inhibits structures of the pterygopalatine fossa, including the sphenopalatine ganglion (SPG) and the maxillary division of the trigeminal nerve.' The device delivers dry room-temperature air into one nostril with a nebulized saline mist for comfort and to facilitate evaporation. The evaporation from liquid to gas requires energy drawn from the surrounding tissues, particularly the vascularized membranes of the nasal turbinates. This purportedly results in a localized cooling effect targeting the structures of the pterygopalatine fossa, including the SPG and maxillary division of the trigeminal nerve (V2), both areas integrally involved with migraine and cluster headache. This hypothesis has yet to be corroborated; no preclinical trials have shown any electrical effect on the SPG. The Mi-Helper is not the same as remote electrical neuromodulation (REN) or other electrical stimulation devices that are already cleared by the FDA for the acute care and/or prevention of migraine attacks. REN uses electrical stimulators and works on various combinations of peripheral nerves involved with migraine. [By way of disclosure, I recently authored a poster on REN.] What Next CALM 3, a third, larger, phase 3 trial of the Mi-Helper is underway. It will test a 10 LPM dose of dehumidified air against a 2 LPM sham. According to CEO Steve Schaefer, it should be completed in September, 2025. I believe that we need to see data from at least two carefully done phase 3 trials at the correct flow rate (10 LPM), in an appropriate number of patients, before we will know if this device can successfully treat migraine, but the results so far are very promising.
New York Post
2 days ago
- Health
- New York Post
Weed can help your migraines, says new study — if you use it the right way
High hopes for headache relief. A landmark new study suggests that inhaling a precise blend of CBD and THC can provide fast, meaningful relief from migraines. The research — presented at the American Headache Society (AHS) Annual Meeting 2025 — is the first of its kind. 4 The research — presented at the American Headache Society (AHS) Annual Meeting 2025 — is the first of its kind. Kateryna – 'This is the first placebo-controlled study in this space,' Dr. Nathaniel M. Schuster, a pain and headache neurologist and associate professor of anesthesiology at the UC San Diego (UCSD) Health Center for Pain Medicine, told Medscape Medical News. 'It's the first real — to me — compelling evidence for the antimigraine effects of cannabis in humans.' Scientists provided 92 patients — mostly women, with an average age of 41 — a treatment of 6% THC, 11% CBD, a combination of 6% THC and 11% CBD or a placebo. Roughly 67.2% in the THC/CBD group reported pain relief at 2 hours, compared to 46.6% in the placebo group. And approximately 34.5% of patients in the THC/CBD group achieved 'pain freedom' within that timeframe, compared to 15.5% in the placebo group. Patients also reported sustained pain relief up to 24 hours and most bothersome symptom freedom lasted through 48 hours. 4 'It's the first real — to me — compelling evidence for the antimigraine effects of cannabis in humans,' Schuster said. ststoev – Best of all: there were no serious side effects, although people in the THC-only group definitely got a little more high. 'It's known that CBD is a noncompetitive, negative allosteric modulator of the CB-1 [cannabinoid receptor 1] receptor that decreases the psychoactive side effects of the THC,' Schuster said. It's a big win for weed but, before you get rolling, Schuster noted that the patients received very controlled doses. 'A lot of neurologists, myself included, suspect that there could be medication overuse headache with [using] cannabinoids frequently,' he said. 'When I counsel patients now, I say, 'Look, we were only studying infrequent — four times over the course of a year — administration.'' 4 'A lot of neurologists, myself included, suspect that there could be medication overuse headache with [using] cannabinoids frequently,' he said. Africa Studio – He encouraged patients to limit the treatment to under 10 times per month and to 'optimally be using it really for those migraines that would not respond to standard-of-care therapy.' Weed has skyrocketed in popularity since 38 states and DC have legalized it for medical use. Of those, 24 states and DC have also cleared the way for adults 21 and over to use it recreationally. Research suggests that marijuana has the potential to ease chronic pain and reduce muscle spasms and stiffness linked to MS. Cannabis products have also been shown to boost appetite in HIV/AIDS and cancer patients, and combat chemo-related nausea. 4 Weed has skyrocketed in popularity since 38 states and DC have legalized it for medical use. Of those, 24 states and DC have also cleared the way for adults 21 and over to use it recreationally. amenic181 – Other potential benefits include easing stress, alleviating PTSD symptoms and aiding sleep in some people. However, mounting evidence does suggest it can pose risks to your heart, with one recent study showing marijuana has as much of a negative impact on cardiovascular health as tobacco — even if you don't smoke. Another recent study suggests that cannabis use raises the risk of heart attack and stroke more than cocaine, while other research claims it's sending older people to the hospital. Shockingly, scientists have also found that people with cannabis use disorder — that is, using weed enough that it causes problems and impairs your life — have altered dopamine activity in the brain that closely resembles patterns observed in psychosis. 'The biggest problem is that ever since it was made a Schedule 1 narcotic [in 1970], it has made it very difficult to do really well-devised, double-blind, placebo-controlled studies,' Dr. Ken Weinberg, chief medical officer of Cannabis Doctors of New York, previously told The Post. 'I don't think there's enough data.'
Associated Press
18-06-2025
- Health
- Associated Press
AbbVie Announces New Data Demonstrating Atogepant (QULIPTA® / AQUIPTA®) Achieves Superiority Across All Endpoints in Phase 3 Head-to-Head Study Compared to Topiramate for Migraine Prevention
NORTH CHICAGO, Ill., June 18, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from its Phase 3 TEMPLE multicenter, randomized, double-blind, head-to-head study evaluating the tolerability, safety and efficacy of atogepant (QULIPTA® / AQUIPTA®, 60 mg once daily) compared to the highest tolerated dose of topiramate (50, 75 or 100 mg/day) in adult patients with a history of four or more migraine days per month.1 The study met the primary endpoint of treatment discontinuation due to adverse events (AEs), demonstrating that atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, had fewer discontinuations due to AEs than topiramate, an anticonvulsant medication also approved for migraine prevention. Over the 24-week double-blind treatment period, discontinuation due to AEs was significantly lower with atogepant (12.1%) compared to topiramate (29.6%), representing a relative risk of 0.41 (95% CI: 0.28, 0.59; p<0.0001).1 The study also met all six secondary endpoints, including a key measure of clinical efficacy: 64.1% of patients on atogepant achieved a ≥50% reduction in mean monthly migraine days (MMD) during months 4 to 6 of the double-blind treatment period compared to 39.3% of patients on topiramate (p<0.0001).1 'These TEMPLE data affirm recommendations from the American Headache Society and International Headache Society, highlighting the role of CGRP pathway inhibitors as first-line preventive treatment options for migraine,' said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. 'This study demonstrates our commitment to improving treatment options and advancing care standards for people living with this debilitating disease.' Migraine continues to be underdiagnosed and undertreated, despite significant burden on patients' lives.2 It is a complex neurological disease that affects approximately 14% of the global population and ranks as the second leading cause of disability worldwide.2 Despite its prevalence and disabling impact, there are numerous gaps in patient care related to the standards for preventive treatment. Notably, over 50% of people currently using preventive medications still qualify for further preventive treatment, indicating that their current therapies may not be providing sufficient relief.3 'Far too often, people living with migraine struggle with meeting their treatment goals despite available and accessible preventive options,' said Jaclyn Duvall, M.D., neurologist and founder of Headache Specialists of Oklahoma. 'The TEMPLE data provide a patient-centered measure of treatment effectiveness by capturing both efficacy and tolerability, representing a meaningful way to evaluate the real-world impact of treatment persistence in migraine prevention.' The AE profile of atogepant observed in this active-controlled study was generally consistent with its established safety profile from prior studies.1 Atogepant, marketed as AQUIPTA® in the EU and QULIPTA® in the U.S., Canada, Israel and Puerto Rico, is approved in 60 countries. Atogepant is a once-daily oral CGRP receptor antagonist, proven to prevent both episodic and chronic migraine in adults. Full results from the TEMPLE study will be presented at an upcoming medical meeting. About the TEMPLE Study TEMPLE is a Phase 3, multicenter, randomized, double-blind, active-controlled trial evaluating the tolerability, safety, and efficacy of atogepant versus topiramate in adult patients with a history of four or more migraine days per month. The trial randomized 545 participants with episodic or chronic migraine aged 18 and older across 73 sites in Europe, Israel and Canada. The study was conducted in two distinct periods. In the initial 24-week Double-Blind Treatment Period, which included a 6-week up-titration phase and an 18-week maintenance phase, participants were randomized to receive either atogepant (60 mg once daily) or the highest tolerated dose of topiramate (ranging from 50 to 100 mg/day). Following this, eligible participants continued into a 52-week Open-Label Treatment Period, during which all received atogepant (60 mg once daily). Throughout the study, patient reported outcomes were regularly collected and patients were continuously monitored for safety and tolerability through clinical assessments and lab tests. The primary endpoint was the percentage of patients who discontinued the study treatment due to AEs during the 24-week double-blind treatment period. An electronic diary (eDiary) was used to collect data on headache frequency, duration, symptoms, acute medication use, and various patient-reported outcomes. More information on the TEMPLE trial can be found on (NCT05748483). About Atogepant Atogepant is a once-daily orally administered CGRP receptor antagonist specifically developed for the preventive treatment of migraine in adults. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. Studies have shown that CGRP levels are elevated during migraine attacks. Atogepant, marketed as AQUIPTA® in the EU and QULIPTA® in the U.S., Canada, Israel and Puerto Rico, is approved in 60 countries. U.S. Uses and Important Safety Information What is QULIPTA® (atogepant)? QULIPTA is a prescription medicine used for the preventive treatment of migraine in adults. IMPORTANT SAFETY INFORMATION FOR QULIPTA® Do not take QULIPTA if you have had an allergic reaction to atogepant or any ingredients in QULIPTA. Before taking QULIPTA, tell your healthcare provider about all your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. QULIPTA may affect the way other medicines work, and other medicines may affect how QULIPTA works. Your healthcare provider may need to change the dose of QULIPTA when taken with certain other medicines. QULIPTA can cause serious side effects, including: The most common side effects of QULIPTA are nausea, constipation, and fatigue/sleepiness. These are not all the possible side effects of QULIPTA. QULIPTA is available in 10 mg, 30 mg, and 60 mg tablets. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit to learn more. Please see full Prescribing Information. Globally, prescribing information varies; refer to the individual country product label for complete information. About AbbVie in Migraine At AbbVie, we are committed to empowering people living with migraine disease. We advance science that enables healthcare providers to care for people impacted across the spectrum of migraine. Through education and partnerships with the migraine community, we strive to help those with migraine navigate barriers to care, access effective treatments, and reduce the impact of migraine on their lives. In the United States, AbbVie is the only company with three prescription treatments designed to meet patient needs across the spectrum of migraine to help patients living with this debilitating disease. About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on LinkedIn,Facebook, Instagram, X (formerly Twitter), and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words 'believe,' 'expect,' 'anticipate,' 'project' and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, 'Risk Factors,' of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. ALL-NEUR-250043 Contact(s): Global Media: Amber Landis +1 (231) 557-6596 [email protected] U.S. Media: Sara Sanders +1 (973) 307-6145 [email protected] References View original content: SOURCE AbbVie
Yahoo
18-06-2025
- Health
- Yahoo
AbbVie Announces New Data Demonstrating Atogepant (QULIPTA® / AQUIPTA®) Achieves Superiority Across All Endpoints in Phase 3 Head-to-Head Study Compared to Topiramate for Migraine Prevention
TEMPLE, a Phase 3 multicenter, randomized, double-blind, head-to-head study, evaluated the tolerability, safety and efficacy of atogepant compared to topiramate for the preventive treatment of migraine in adult patients with a history of four or more migraine days per month1 Atogepant met the primary endpoint of fewer treatment discontinuations attributed to adverse events versus topiramate, and all six secondary endpoints achieved statistical significance for superiority versus topiramate, demonstrating clinical efficacy1 Full results from the TEMPLE study will be presented at an upcoming medical meeting NORTH CHICAGO, Ill., June 18, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from its Phase 3 TEMPLE multicenter, randomized, double-blind, head-to-head study evaluating the tolerability, safety and efficacy of atogepant (QULIPTA® / AQUIPTA®, 60 mg once daily) compared to the highest tolerated dose of topiramate (50, 75 or 100 mg/day) in adult patients with a history of four or more migraine days per month.1 The study met the primary endpoint of treatment discontinuation due to adverse events (AEs), demonstrating that atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, had fewer discontinuations due to AEs than topiramate, an anticonvulsant medication also approved for migraine prevention. Over the 24-week double-blind treatment period, discontinuation due to AEs was significantly lower with atogepant (12.1%) compared to topiramate (29.6%), representing a relative risk of 0.41 (95% CI: 0.28, 0.59; p<0.0001).1 The study also met all six secondary endpoints, including a key measure of clinical efficacy: 64.1% of patients on atogepant achieved a ≥50% reduction in mean monthly migraine days (MMD) during months 4 to 6 of the double-blind treatment period compared to 39.3% of patients on topiramate (p<0.0001).1 "These TEMPLE data affirm recommendations from the American Headache Society and International Headache Society, highlighting the role of CGRP pathway inhibitors as first-line preventive treatment options for migraine," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "This study demonstrates our commitment to improving treatment options and advancing care standards for people living with this debilitating disease." Migraine continues to be underdiagnosed and undertreated, despite significant burden on patients' lives.2 It is a complex neurological disease that affects approximately 14% of the global population and ranks as the second leading cause of disability worldwide.2 Despite its prevalence and disabling impact, there are numerous gaps in patient care related to the standards for preventive treatment. Notably, over 50% of people currently using preventive medications still qualify for further preventive treatment, indicating that their current therapies may not be providing sufficient relief.3 "Far too often, people living with migraine struggle with meeting their treatment goals despite available and accessible preventive options," said Jaclyn Duvall, M.D., neurologist and founder of Headache Specialists of Oklahoma. "The TEMPLE data provide a patient-centered measure of treatment effectiveness by capturing both efficacy and tolerability, representing a meaningful way to evaluate the real-world impact of treatment persistence in migraine prevention." The AE profile of atogepant observed in this active-controlled study was generally consistent with its established safety profile from prior studies.1 Atogepant, marketed as AQUIPTA® in the EU and QULIPTA® in the U.S., Canada, Israel and Puerto Rico, is approved in 60 countries. Atogepant is a once-daily oral CGRP receptor antagonist, proven to prevent both episodic and chronic migraine in results from the TEMPLE study will be presented at an upcoming medical meeting. About the TEMPLE StudyTEMPLE is a Phase 3, multicenter, randomized, double-blind, active-controlled trial evaluating the tolerability, safety, and efficacy of atogepant versus topiramate in adult patients with a history of four or more migraine days per month. The trial randomized 545 participants with episodic or chronic migraine aged 18 and older across 73 sites in Europe, Israel and Canada. The study was conducted in two distinct periods. In the initial 24-week Double-Blind Treatment Period, which included a 6-week up-titration phase and an 18-week maintenance phase, participants were randomized to receive either atogepant (60 mg once daily) or the highest tolerated dose of topiramate (ranging from 50 to 100 mg/day). Following this, eligible participants continued into a 52-week Open-Label Treatment Period, during which all received atogepant (60 mg once daily). Throughout the study, patient reported outcomes were regularly collected and patients were continuously monitored for safety and tolerability through clinical assessments and lab tests. The primary endpoint was the percentage of patients who discontinued the study treatment due to AEs during the 24-week double-blind treatment period. An electronic diary (eDiary) was used to collect data on headache frequency, duration, symptoms, acute medication use, and various patient-reported outcomes. More information on the TEMPLE trial can be found on (NCT05748483). About Atogepant Atogepant is a once-daily orally administered CGRP receptor antagonist specifically developed for the preventive treatment of migraine in adults. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. Studies have shown that CGRP levels are elevated during migraine attacks. Atogepant, marketed as AQUIPTA® in the EU and QULIPTA® in the U.S., Canada, Israel and Puerto Rico, is approved in 60 countries. U.S. Uses and Important Safety Information What is QULIPTA® (atogepant)? QULIPTA is a prescription medicine used for the preventive treatment of migraine in adults. IMPORTANT SAFETY INFORMATION FOR QULIPTA®Do not take QULIPTA if you have had an allergic reaction to atogepant or any ingredients in QULIPTA. Before taking QULIPTA, tell your healthcare provider about all your medical conditions, including if you: Have high blood pressure Have circulation problems in your fingers and toes Have kidney problems or are on dialysis Have liver problems Are pregnant or plan to become pregnant Are breastfeeding or plan to breastfeed Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. QULIPTA may affect the way other medicines work, and other medicines may affect how QULIPTA works. Your healthcare provider may need to change the dose of QULIPTA when taken with certain other medicines. QULIPTA can cause serious side effects, including: Allergic (hypersensitivity) reactions, including anaphylaxis: Serious allergic reactions can happen when you take QULIPTA or days after. Stop taking QULIPTA and get emergency medical help right away if you get any of the following symptoms, which may be part of a serious allergic reaction: swelling of the face, lips, or tongue; itching; trouble breathing; hives; or rash. High blood pressure: New or worsening of high blood pressure can happen. Contact your healthcare provider if you have an increase in blood pressure. Raynaud's phenomenon: A type of circulation problem can worsen or happen. Raynaud's phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing color from pale, to blue, to red. Contact your healthcare provider if these symptoms occur. The most common side effects of QULIPTA are nausea, constipation, and fatigue/sleepiness. These are not all the possible side effects of QULIPTA. QULIPTA is available in 10 mg, 30 mg, and 60 mg tablets. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit to learn more. Please see full Prescribing Information. Globally, prescribing information varies; refer to the individual country product label for complete information. About AbbVie in MigraineAt AbbVie, we are committed to empowering people living with migraine disease. We advance science that enables healthcare providers to care for people impacted across the spectrum of migraine. Through education and partnerships with the migraine community, we strive to help those with migraine navigate barriers to care, access effective treatments, and reduce the impact of migraine on their lives. In the United States, AbbVie is the only company with three prescription treatments designed to meet patient needs across the spectrum of migraine to help patients living with this debilitating disease. About AbbVieAbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. Forward-Looking StatementsSome statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. ALL-NEUR-250043 Contact(s): Global Media:Amber Landis+1 (231) U.S. Media:Sara Sanders+1 (973) References Data on file. AbbVie, Inc. ABVRRTI81148 Steiner TJ, Stovner LJ, Jensen R, et al. Migraine remains second among the world's causes of disability, and first among young women: Findings from GBD2019. The Journal of Headache and Pain.2020;21(1):137. Buse DC, Sakai F, Matharu M, Reed ML, Fanning K, Dabruzzo B, Lipton RB. Characterizing gaps in the preventive pharmacologic treatment of migraine: Multi-country results from the CaMEO-I study. Headache. 2024;64(5):469-481. View original content: SOURCE AbbVie Sign in to access your portfolio
Medscape
12-06-2025
- Health
- Medscape
Migraine Expert Renews Call for Prompt, Effective Management
OTTAWA — Therapies that target calcitonin gene-related peptide (CGRP) should be used up front in the treatment and prevention of migraine because of their efficacy, safety, and potential to modify the disease course, an expert said. Speaking at the annual meeting of the Canadian Neurological Sciences Federation (CNSF) Congress 2025, David Dodick, MD, emeritus professor of neurology at Mayo Clinic in Phoenix, reiterated the appeal that was first published in an American Headache Society position statement: That migraine therapies that target CGRP become first-line treatments for migraine. A Bold Call Some of the available monoclonal antibodies to treat migraine include erenumab, fremanezumab, galcanezumab, and eptinezumab. The class of 'gepants' includes rimegepant and atogepant. All these treatments target CGRP. 'This was a type of expert consensus opinion,' Dodick told Medscape Medical News , referring to the 'rather bold' position statement. 'The real-world evidence supports what we saw in clinical trials, and we now know the safety profile of these [therapies] because we've had them for almost 8 years of use in clinical practice. They are not first-line [therapies] simply because of cost.' The largest prospective study on the use of anti-CGRP monoclonal antibodies demonstrated robust responses to these therapies. Because CGRP-targeting therapies are well tolerated, discontinuation due to adverse events is generally not a concern, and increased efficacy may be realized if patients stay the course with CGRP-targeting therapies, said Dodick. 'You can imagine that if people are able to tolerate them and stay on these drugs longer, then efficacy is cumulative over time. Adherence and compliance increase the response rate over time,' said Dodick. Early Treatment Vital 'It really does matter how early you get to the patient and treat them effectively, both from the standpoint of treating an individual episode of migraine and from the prevention standpoint: That is, treating the disease earlier,' said Dodick. 'The more frequent that migraines are, and the more you allow them to be frequent, the more likely they are to progress to a daily migraine, and the more difficult they are to manage.' In the US and Canada, patients with migraine must first fail other treatments before they are prescribed newer agents like CGRP monoclonal antibodies or gepants, and this requirement creates the potential for a lapse in care, noted Dodick. 'Patients can become discouraged and lost to follow-up if they fail one medicine and then two medicines,' which he said supports the case for first-line access to CGRP-targeting migraine therapies. High-Impact Agents The efficacy of migraine treatments that target CGRP is convincing, said Michael Hill, MD, professor of clinical neuroscience at the University of Calgary's Cumming School of Medicine, Calgary. 'For some patients, they can get back to living a relatively normal life,' said Hill, who also is CNSF president. 'It can be a remarkable evolution. They go from being nonfunctioning and not working to being fully functional again because their migraine is not chronic, or their recurrent migraines are not so disabling.' Seeing patients who are unable to access these therapies is disheartening, Hill told Medscape Medical News. 'It is hard to see them denied this therapy.' The preventive potential that these therapies could offer would certainly be welcome, Hill added. 'The idea that some of these people who start with simple migraine and progress to a chronic, refractory migraine state, and that these might actually be preventable with early treatment, is really exciting.' Episodic treatment of migraine has not altered the disease course. 'The focus on migraine therapy has been on acute treatment and not so much on this idea that you might prevent the evolving chronicity of the disease.'
