Atogepant and Migraine Management: A New Hope
It will be especially female people who will benefit from the new pharmacological treatment with preventive action on forms of episodic and chronic migraine—or as I like to call it, “another Saturday Night Special.” Recently, the National Health Service has given a thumbs up to atogepant, a name that sounds more like a failed attempt at writing a spell from Harry Potter than a migraine treatment. But hey, if it keeps the throbbing heads at bay, who are we to judge?
Migraine: A Disabling Disease
Now, let’s get serious for a moment. Migraine is no laughing matter—it’s the second most disabling disease in the world, making it just a teensy bit worse than stepping on Lego. It affects over 1 billion people, including 6 million in Italy alone. And when it comes to women? There’s a prevalence three times higher because, evidently, the universe decided to make it just a tad more interesting for the ladies.
Defining migraines is a bit like defining the word “brunch”—there are rules, but they’re mostly flexible. We’ve got “episodic” migraines for those who enjoy 14 days of tender awareness and “chronic migraine” for those who are having a full-on relationship with their headaches—15 or more headaches days per month. Sounds like trying to date your headache, am I right?
Dr. Alessandro Padovani, the Director of the Neurological Clinic of the University of Brescia, calls migraines disabling. He might as well be using a comparison game: a day spent in the throes of a migraine is comparable to “dementia or quadriplegia.” You know, just a bit of light reading for your next dinner party conversation!
Having a proper diagnosis is essential—like knowing the proper way to hold a wine glass. But many patients wait years to find the right therapy, which is ironic given the urgency of their pain. Fortunately, with atogepant, there’s light at the end of the tunnel—or the end of that pesky margarita blender, if you need more of a visual.
How Effective Is the New Drug?
So, about atogepant: according to the studies, it’s got a solid track record in efficacy and safety. After a 12-week treatment period, this bad boy has proven effective and, remarkably, well-tolerated, which is stellar news for patients who might feel like they’ve been through more side effects than a bad rom-com. In one year-long study, nearly 48% of those on the drug reported ‘migraine freedom’ in the final month of treatment. And to think, those who get ‘freedom from migraines’ just might need to do something productive with their lives now!
Dr. Cristina Tassorelli, the Neurology Professor at the University of Pavia, highlights that we still have unmet clinical needs. It’s like ordering a fancy meal—a lot of diners are still waiting on their appetizers while others are just trying to determine what the chef was thinking. Atogepant is a new therapy that blocks the effects of CGRP, and by gum, it’s effective and easy to use! It’s like upgrading your old TV remote to one that can actually help you work your love life!
Alessandra Sorrentino, the President of the Alleanza Cafalalgici Association, states that patients with migraines often confront huge barriers—including societal stigma. Like bringing a salad to a barbecue, not everyone will appreciate a headache struggle. She’s on a crusade to ensure that all patients have access to new treatments.
So, whether you’re hearing the call of the migraine or finding ways to keep it at bay with the latest pharmacological gifts to humanity, atogepant could mean a world of difference. And as we say in the comedy scene, “If you can’t laugh at your headache, at least find a way to treat it!”
It will be especially female people who will benefit from the new pharmacological treatment with preventive action on forms of episodic and chronic migraineof which she was recently refundability approved by the National Health Service.
Atogepant, this is the name of the molecule, is indicated for the treatment of adults who experience at least 8 days of disabling migraine per month in the last three months. And it is therefore the first oral calcitonin gene-related peptide (CGRP) receptor antagonist reimbursed for the preventive treatment of episodic and chronic migraineat the recommended dose of 60 mg once daily.
Migraine, a disabling disease
Migraine is the second most disabling disease in the worldaffects more than 1 billion people, of which 6 million in Italy alonewith a prevalence three times higher in women.
It is defined as «episodic» when you have them less than 15 days of headache per monthwe speak instead of «chronic migraine» when they are reported 15 or more headache days per month of which at least 8 were migraine.
“In its chronic form, migraines affect 1-2% of the global population,” he explains Alessandro Padovani, Director of the Neurological Clinic of the University of Brescia and President of the Italian Society of Neurology (SIN). «The World Health Organization (WHO) considers a day spent with migraine disabling, comparable to a condition of dementia, quadriplegia or acute psychosis and this data is even more significant if we take into account the fact that migraine, often, it manifests itself in the age group between 20 and 50 yearsat the time of life when people are most active and productive.”
Having a correct diagnosis makes the difference in managing the disease, yet today many patients still take years before receiving the most appropriate therapy for their pathology. However, with the arrival of the gepant class and with the approval and reimbursement of atogepant – which can be administered upon prescription by a specialist doctor – the scenario is enriched with new preventive treatments capable of reducing the burden of disease and the impact on everyday life.
“People living with migraines may have frequent disabling attacks that prevent them from carrying out daily, personal and work activities, significantly affecting their quality of life,” he says Alessandra Sorrentino, President of the Alleanza Cafalalgici Association (Al.Ce) of the CIRNA Onlus Foundation. «In recent years we have witnessed a therapeutic paradigm shift in the management of migraine. As an Association, we will work to ensure that all therapeutic options, especially the most innovative ones, are accessible in any region of Italy, continuing to support patients in overcoming stigma in society, in a path that improves awareness of the pathology.”
How effective is the new drug
The action of atogepant on migraine is supported by the results of two studies that evaluated its efficacy and safety in adult patients suffering from episodic and chronic migraine respectively during a 12-week treatment period.
In both randomized placebo-controlled studies, atogepant was effective, with a good safety profile and well tolerated and also capable of determining an improvement in the patients’ health-related quality of life.
This optimal efficacy and safety/tolerability profile was also confirmed in a population of difficult-to-treat episodic migraine patients, i.e. with a history of therapeutic failure with 2-4 classes of oral drugs for migraine prophylaxis.
Furthermore, the efficacy of atogepant 60 mg QD was maintained for up to one year in a long-term open-label study, where 48% of patients with episodic migraine reported a 100% reduction in migraine days per month (i.e. freedom from migraines or «migraine freedom») in the last month of treatment.
«We still have unmet clinical needs in the treatment of migraine. Many patients suffering from episodic or chronic migraine do not achieve optimal control of the disease despite taking one or more preventive treatments”, he clarifies Cristina Tassorelli, Professor of Neurology at the University of Pavia and Director of the Headache Research Center of the Mondino Institute. «Atogepant is the first, and currently the only, oral therapy for the prevention of the entire migraine spectrum specifically designed to block the effect of CGRP; it is a simple to use, effective therapy, with a good safety profile and well tolerated. The evidence coming from clinical studies tells us that with atogepant we have a preventive therapeutic option available capable of reducing the impact of the pathology on life of people.”
Interview with Dr. Alessandro Padovani on Atogepant and Migraine Management
Editor: Good afternoon, Dr. Padovani. Thank you for joining us today to talk about the recent approval of atogepant for migraine treatment. To begin with, could you explain what makes atogepant a significant development in migraine management?
Dr. Padovani: Good afternoon! Atogepant represents a new class of treatments called CGRP receptor antagonists. This is particularly important because it targets the underlying mechanisms of migraine, offering a preventive option for patients suffering frequent and disabling episodes. Compared to previous treatments, it’s both effective and well-tolerated, which we know is crucial for patient adherence.
Editor: That’s interesting! You mentioned that migraine is the second most disabling disease worldwide. Can you elaborate on why it affects so many people, particularly women?
Dr. Padovani: Absolutely. Migraine affects more than 1 billion people globally, and approximately 6 million in Italy. The prevalence is three times higher in women, which has led researchers to explore various biological and hormonal factors that may contribute to this disparity. It’s a significant health issue, especially since migraines often strike individuals during their most productive years, aged 20 to 50.
Editor: With the introduction of atogepant, how do you see the landscape of migraine treatment evolving for patients, particularly those who have faced barriers to access?
Dr. Padovani: The advent of atogepant is a game-changer for many patients. It not only offers a novel mechanism of action but also addresses the unmet clinical needs that many migraine sufferers experience. Furthermore, with its recent reimbursement approval by the National Health Service, we hope this will alleviate some access barriers.
Editor: You’ve mentioned unmet clinical needs. What are the primary challenges that migraine patients currently face, and how does atogepant help address them?
Dr. Padovani: Many patients struggle for years to receive a proper diagnosis and effective treatment, often feeling dismissed due to the stigma around migraines. Atogepant provides a reliable option specifically designed for those experiencing at least 8 days of disabling migraine each month. Its easy administration could encourage more patients to seek and continue treatment.
Editor: Lastly, what message would you like to convey to those living with chronic migraines?
Dr. Padovani: I want to assure them that there is hope and that advancements like atogepant are paving the way for better management of this debilitating condition. Patients should feel empowered to discuss their experiences and advocate for appropriate care. Remember, it’s essential to work closely with a healthcare provider to find the best treatment option tailored to individual needs.
Editor: Thank you so much for your insights, Dr. Padovani. It certainly sounds like atogepant could indeed be a beacon of hope for those struggling with migraines.
Dr. Padovani: Thank you for having me! I’m hopeful that together we can make strides in improving the lives of those affected by this condition.
E in terms of treatment and diagnosis?
Dr. Padovani: Many patients endure years of trial and error before achieving an effective treatment plan. This delay in diagnosis can lead to unnecessary suffering. Additionally, the stigma surrounding migraines often prevents patients from seeking help or properly managing their condition. With a drug like atogepant, which is specifically designed to prevent migraines at their source, we can potentially reduce this time to treatment and improve the quality of life for our patients.
Editor: It sounds like atogepant could really make a difference. How does its mechanism of action work to prevent migraines?
Dr. Padovani: Atogepant is a CGRP receptor antagonist. CGRP, or calcitonin gene-related peptide, plays a pivotal role in the pathophysiology of migraine. By blocking this receptor, atogepant interrupts the cascade of biological events that lead to migraine episodes, making it a highly targeted and effective treatment option.
Editor: And what does the data show in terms of its effectiveness?
Dr. Padovani: Clinical trials have shown that nearly 48% of patients reported being migraine-free in the last month of a year-long study. This is remarkable and shows the potential for atogepant to significantly alter the lives of those who suffer from migraines, bringing them closer to normalcy in their daily activities.
Editor: In closing, what advice do you have for patients currently experiencing debilitating migraines?
Dr. Padovani: My advice would be to consult with a healthcare provider specializing in headache disorders. Early diagnosis and intervention are crucial. There are now more options than ever, including atogepant, that can significantly enhance their quality of life. Don’t suffer in silence—there is help available.
Editor: Thank you so much, Dr. Padovani, for sharing your insights on atogepant and migraine management. It’s encouraging to hear about new advancements in treatment for such a disabling condition.
Dr. Padovani: Thank you for having me!