Key clinical point: The safety and tolerability of once-daily atogepant observed over 40 weeks in this extension trial aligns with profiles from the pivotal phase 3 trials with no new safety signals identified in patients with episodic migraine.
Major finding: Nearly 63% of patients reported treatment-emergent adverse events, most being mild or moderate, with upper respiratory tract infection (5.5%) and urinary tract infection (5.3%) being most frequent. Treatment discontinuation rates due to lack of efficacy (0.6%) or adverse events (3.6%) were low. No deaths were reported.
Study details: Findings are from the 309-OLEX trial , an open-label extension of phase 3 ADVANCE trial, including 685 patients with episodic migraine with or without aura who received 60 mg atogepant once daily for 40 weeks.
Disclosures: This study was supported by AbbVie Inc. (formerly Allergan). Five authors declared being full-time or former employees of or holding stock or stock options in AbbVie. Several authors reported ties with various sources, including AbbVie.
Source: Klein BC et al. 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. Cephalalgia. 2023 (Jan 9). Doi: 10.1177/03331024221128250