VYEPTI Rx

Approval was based on data from two phase 3, placebo-controlled trials, PROMISE 1 (N=665; mean migraine frequency at baseline: 8.6 migraines/month) and PROMISE 2 (N=1072; mean migraine frequency at baseline: 16.1 migraines/month), which evaluated the efficacy and safety of Vyepti as a preventive treatment of episodic and chronic migraine, respectively. 

Both studies randomly assigned  patients 1:1:1 to receive Vyepti 100mg, 300mg, or placebo; patients were allowed to use concurrent acute migraine or headache medications. The primary endpoint was the change from baseline in mean monthly migraine days (MMD) over months 1-3. Secondary end points included the percentage of patients with at least 50% and 75% reductions from baseline in MMD over months 1-3.

In PROMISE 1 (ClinicalTrials.gov Identifier: NCT02559895), Vyepti was associated with a significantly greater mean change from baseline in MMD compared with placebo over months 1-3: -3.9 days for 100mg (P=.018), -4.3 days for 300mg (P <.001), and -3.2 days for placebo. Moreover, 49.8% (P =.009) and 56.3% (P <.001) of patients treated with Vypeti 100mg and 300mg, respectively, demonstrated at least 50% reduction in MMD compared with 37.4% of placebo patients. The percentage of responders with at least 75% reduction in MMD were: 22.2% for 100mg (P = not statistically significant), 29.7% for 300mg (P <.001), and 16.2% for placebo.

In PROMISE 2 (ClinicalTrials.gov Identifier: NCT02974153), Vyepti demonstrated a statistically greater mean change from baseline in MMD compared with placebo over months 1-3: -7.7 days for 100mg (P <.001), -8.2 days for 300mg (P <.001) vs -5.6 days for placebo. The percentage of responders with at least 50% reduction and 75% reduction in MMD were: 57.6% (P <.001) and 26.7% (P <.001) for 100mg, 61.4% (P <.001) and 33.1% (P <.001) for 300mg, compared with 39.3% and 15% for placebo.

In both studies, treatment benefit over placebo was observed for both doses as early as day 1 post infusion; a greater percentage of placebo-treated patients had migraines on individual days during the first 7 days of treatment compared with Vyepti-treated patients.