There is exciting news about new migraine-specific drugs being approved by the US Food and Drug Administration!  Atogepant, a new once-a-day oral preventive treatment for episodic migraine was approved in late September for adults.  

The Gepant Family

QULIPTA (atogepant) is in the same “gepant” family as UBRELVY (ubrogepant) and NURTEC (rimegepant). While Ubrogepant is to be used as needed for the acute treatment of migraine attacks, Rimegepant can be used either on an as-needed medication for the acute treatment of migraine attacks or as a medication to be taken every other day to prevent migraine attacks. Atogepant is meant to be taken every day to prevent migraine attacks -- i.e. to decrease the frequency, severity, and disability of migraine attacks. 

Dosages and Warnings

Atogepant comes in three different doses (10 mg, 30 mg, and 60 mg tablets), which helps accommodate for potential drug-drug interactions seen between gepants and some other medications. For example, it is recommended to take the lower dose of 10mg daily if you are also taking strong CYP3A4 inhibitors such as certain antibiotics or blood pressure medications. 

Given the potential interactions between atogepant and other substances, please make sure to tell your provider about all the other medications(prescription and over-the-counter), vitamins, grapefruit, and herbal supplements you are taking. 

Atogepant should currently be avoided in pregnancy and breastfeeding; more studies will be needed to assess its safety or risk during pregnancy or breastfeeding. Atogepant should also be avoided if you have severe liver disease. 

Atogepant’s Trial 

Atogepant’s FDA approval was based on the results of the ADVANCE randomized controlled trial that assessed the efficacy, safety, and side effects of atogepant 10 mg, 30 mg, and 60 mg tablets. The study’s 805 participants were between 18 and 73 years old and had between 4 and 14 migraine days per month at baseline (with an average of 7.4 migraine days per month). It’s worth noting that this study did not include participants with chronic migraine or some other types of headache diseases, who were pregnant or breastfeeding, whose migraine attacks did not significantly improve after trying more than four oral preventive medications, with opiate or barbiturate (such as Fioricet) use of more than 2 days per month, with triptan or ergots use of more than 9 days per month. 

The participants were asked to take a pill daily for 12 weeks and record their migraine attacks. They were not informed whether the pill they were assigned was a placebo pill, 10mg, 30mg, or 60mg of atogepant. The primary result of interest was the change in monthly migraine days between participants’ baseline and after taking atogepant daily for 12 weeks.  

The mean change in monthly migraine days between the beginning and the end of the study was 3.7 fewer migraine days per month for the group who took 10 mg atogepant pills, 3.9 fewer migraine days per month for the group who took 30mg atogepant pills, and 4.2 fewer migraine days per month for the group who took 60mg atogepant pills compared to 2.5 fewer migraine days with a placebo. 

Although these medications were not compared head-to-head yet in clinical studies, to give you some reference, fremanezumab (AJOVY) was found to reduce the number of migraine days per month by 4 days compared to 2.6 days for the placebo. Galcanezumab (EMGALITY) was found to reduce the number of migraine days per month by 4.7 and 4.3 days (respectively in the EVOLVE 1 and EVOLVE 2 studies) compared to 2.8 and 2.3 days for the placebo. 

This study also showed that atogepant helps reduce the number of headache days per month and the number of days per month one needs to take acute medications for migraine attacks. 

Atogepant was not associated with severe side effects in this study. The most common side effect was non-serious constipation (6.9-7.7% of participants on atogepant). There will be more studies in the future to look at data in the long-run and real-world data in clinical practice.

If you’re interested in speaking with a neurologist about whether atogepant could be right for your specific case, sign up for Neura membership today.