In chronic migraine, AQUIPTA® is generally well tolerated1
- The safety profile of AQUIPTA® was evaluated in 2,657 patients with migraine who received at least one dose1
- The most commonly reported adverse drug reactions were nausea (7%), constipation (7%) and fatigue/somnolence (5%)1
- The majority of cases were mild and none were serious1
- The adverse reaction that most commonly led to treatment discontinuation was nausea (0.6%)1
PROGRESS study
In the 12-week pivotal PROGRESS trial in patients with chronic migraine (N=778), AQUIPTA® 60 mg once‑daily (n=261) was generally well tolerated versus placebo (n=255) across 12 weeks.2*
- Rates of treatment-emergent adverse events (TEAEs) leading to treatment discontinuation were similar in the placebo (4%) and AQUIPTA® 60 mg once‑daily (3%) arms2
- Serious TEAEs were reported in 3% of patients in the AQUIPTA® 60 mg once‑daily arm (versus 1% in placebo arm); none of these were considered related to the study drug2
Adverse events occurring in ≥5% of patients in any group (safety population)2
Adapted from Pozo-Rosich P et al. 20232
*AQUIPTA® was evaluated for the prophylaxis of chronic migraine. The chronic migraine study (PROGRESS) enrolled patients who met International Classification of Headache Disorders criteria for chronic migraine. Patients with myocardial infarction, stroke, or transient ischaemic attacks within 6 months prior to screening were excluded.2
UK-AQP-250088 | Date of preparation: March 2025.
Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk
Adverse events should also be reported to AbbVie on GBPV@abbvie.com