Safety and tolerability results of atogepant for the preventive treatment of episodic migraine from a 40-week, open-label multicenter extension of the phase 3 ADVANCE trial

• Published in: Cephalalgia 2023-01, Vol.43 (1), p.3331024221128250-3331024221128250
• Main Authors: Klein, Brad C, Miceli, Rosa, Severt, Lawrence, McAllister, Peter, Mechtler, Laszlo, McVige, Jennifer, Diamond, Merle, Marmura, Michael J, Guo, Hua, Finnegan, Michelle, Trugman, Joel M
• Format: Article
• Language: English
• Subjects: Double-Blind Method; Humans; Migraine Disorders - drug therapy; Migraine Disorders - prevention & control; Nausea; Treatment Outcome
• ISSN: 0333-1024; 1468-2982
• DOI: 10.1177/03331024221128250

Background Atogepant is a United States Food and Drug Administration-approved oral calcitonin gene-related peptide receptor antagonist for the preventive treatment of episodic migraine. The study objective was to evaluate the long-term safety and tolerability of atogepant in participants who completed the phase 3 ADVANCE trial (NCT03777059). Methods This 40-week, open-label extension trial (NCT03939312) monitored safety in participants receiving oral atogepant 60 mg once daily, followed by a four-week safety follow-up period. Results Of the 685 participants taking at least one dose of atogepant, the treatment period was completed by 74.6% of participants with a mean (standard deviation) treatment duration of 233.6 (89.3) days. Treatment-emergent adverse events occurred in 62.5% of participants, with upper respiratory tract infection (5.5%), urinary tract infection (5.3%), nasopharyngitis (4.8%), sinusitis (3.6%), constipation (3.4%), and nausea (3.4%) occurring at ≥3%. Serious adverse events were observed in 3.4% of participants (none were treatment-related), and there were no deaths. Adverse events leading to discontinuation occurring at >0.1% were nausea (0.4%) and abdominal pain, vomiting, weight decrease, dizziness, and migraine (0.3% each). Conclusion These results are consistent with atogepant’s known safety profile and support long-term use of atogepant 60 mg once daily dosing as safe and well tolerated. ClinicalTrials.gov Registration Number: NCT03939312