- Federal regulators have approved the use of atogepant for the treatment of chronic migraine.
- The drug, sold under the brand name QULIPTA, was approved last year to treat episodic migraine.
- Experts say it’s beneficial to have another migraine treatment available, especially one that is taken in pill form as opposed to being injected.
The Food and Drug Administration (FDA) has approved the migraine drug atogepant (QULIPTA) for use in the preventive treatment of chronic migraine.
The drug was approved last year for the use of episodic migraine and will now also be an option for those with chronic migraine.
“This is certainly good news for those impacted by chronic migraine. It is great to have another therapeutic option for those who are disabled by this disease,” Dr. Andrew Charles, a professor of neurology and director of the University of California Los Angeles Goldberg Migraine Program, told Healthline.
“Atogepant is already approved for the prevention of episodic migraine (migraine with less than 15 days of headache per month), and we have been using it with good success for patients in this category,” he said. “The approval for chronic migraine will allow us to prescribe it within FDA guidelines for those with more frequent headache days, a population in which preventive treatment is essential.”
“Since September 2021, QULIPTA has helped people living with episodic migraine prevent migraine attacks, reducing the daily burden of migraine. Now, those with the most challenging to treat chronic migraine can also rely on QULIPTA to significantly reduce their migraine days,” Dr. Roopal Thakkar, senior vice president and chief medical officer at AbbVie, which manufactures the drug, said in a press statement.
Atogepant works by blocking a chemical called CGRP that plays a role in migraine.
“CGRP is short for calcitonin gene-related peptide… CGRP released in the brain can affect a nerve called your trigeminal nerve, which has been associated with migraine. It has an effect on the blood vessels which has been associated with symptoms that come on with migraine,” explained Dr. Ilan Danan, a sports neurologist and pain management specialist at the Center for Sports Neurology and Pain Medicine at Cedars-Sinai Kerlan-Jobe Institute in Los Angeles.
“This CGRP class of medications that has really come onto the scene in the last several years historically had been injectables, ones that you would administer yourself intramuscularly,” he told Healthline. “But, most recently, there have been a couple of oral medications, not injectable medications, that fall within the CGRP class and as you can imagine, patients are more inclined to ingest a medication orally than administer an injectable, say into their thigh for example.”
In clinical trials, researchers say treatment with atogepant over a 12-week period resulted in a statistically significant reduction in the mean number of monthly days with migraine compared with people who took a placebo.
Chronic migraine refers to migraine that occurs on more than 15 days every month for 3 months and that has features of migraine on at least 8 of those days.
In some cases, those experiencing episodic can progress to having chronic migraine. This can be due to overuse of medication such as NSAIDs and opioids but also an excessive intake of caffeine.
Currently, there is no cure for migraine as the causes behind it are not fully understood.
Treatment options are focused either on relieving symptoms when they occur or preventing migraine from happening in the first place.
Charles argues that for people experiencing chronic migraine, a preventive treatment is crucial, and the approval of atogepant in chronic migraine could fill a need for non-injectable options.
“Preventive treatments are essential for the treatment of chronic migraine. All patients with chronic migraine should be on a preventive treatment,” he said. “We now have five FDA-approved treatments for chronic migraine, including onabotulinum toxin A as well as four different monoclonal antibodies targeting the CGRP pathway. And while these treatments have been life changing for some with chronic migraine, they are all injections and they all have long half-lives, meaning that they stay in the body for weeks or months.”
“Having a tablet that is used for prevention of migraine provides a meaningful new treatment option,” Charles added. “Some may prefer taking a tablet as opposed to injections and, for some, this treatment may simply work better. We have no evidence comparing treatments yet, but we know that the response to migraine therapies can vary significantly from patient to patient, so it is definitely meaningful to have a new treatment option.”
It is thought approximately 3% to 5% of the population of the United States experiences chronic migraine. Globally, up to 148 million people live with chronic migraine.
Chronic migraine may cause moderate, severe or intense pain that may be on one or both sides of the head. It may resemble a throbbing, pulsing or pounding feeling and could worsen with movement.
Along with pain, those with chronic migraine may also experience sensitivity to light and sound as well as nausea and vomiting.
Both Danan and Charles agree that having an additional option for those experiencing the debilitating condition is good news.
“Migraine is a major public health issue, particularly among women,” Charles said. “It is extremely gratifying to see that advances in the understanding of the basic biology of migraine are leading to new therapeutic approaches that can help the hundreds of millions of individuals worldwide who are affected by this disabling disease.”