The research showed that the preventive effect of eptinezumab-jjmr was statistically significant versus placebo as early as day 1 and maintained throughout 3 months post-infusion.
Findings from the phase 3 PROMISE 2 study demonstrated that the use of eptinezumab-jjmr (Vyepti, Lundbeck) as a preventive treatment for chronic migraine in adults significantly reduced the number of mean monthly migraine days (MMD) over months 1-3, according to a company press release.
The research showed that the preventive effect of eptinezumab-jjmr was statistically significant versus placebo as early as day 1 and maintained throughout 3 months post-infusion. Further, approximately one-third of patients on eptinezumab-jjmr reduced the number of mean MMD by 75% or more at month 1. These patients were also more likely to achieve a 75% or greater response during months 1-3 compared with placebo, according to the press release.
These results support the findings from the PROMISE 1 study in adults with episodic migraine, which were published online in February 2020.
Eptinezumab-jjmr was recently approved by the FDA for the preventive treatment of migraine in adults, with the recommended dose at 100 mg every 3 months, although some patients may benefit from a dose of 300 mg. It is the first and only intravenous (IV) infusion for migraine prevention, administered via 30-minute IV every 3 months.
PROMISE 2 was a randomized, double-blind trial in adults with chronic migraine, which was defined as 15-26 headache days per month, of which at least 8 were migraine days. One thousand and seventy-two patients received up to 2 treatments with eptinezumab-jjmr 100 mg, eptinezumab-jjmr 300 mg, or placebo. Each dose was administered via IV on day 0 and by the end of month 3.
Eptinezumab-jjmr was well tolerated in the study with similar rates of treatment-emergent adverse events (AEs) seen versus placebo. The most common AEs from the trials were nasopharyngitis and hypersensitivity.
“The publications of PROMISE 2 and PROMISE 1 in Neurology and Cephalalgia, respectively, underscore the scientific support of Vyepti as a powerful and generally well-tolerated preventive therapy with 4 infusions a year,” said Roger Cady, MD, head of Neurology Medical, Lundbeck Seattle Biopharmaceuticals in a press release. “These publications also further highlight the design of Vyepti as an IV infusion to deliver 100 percent of the medicine into the bloodstream by the end of the infusion.”
VYEPTI™ (eptinezumab-jjmr) Demonstrated Significant Positive Impact in Prevention of Chronic Migraine in Adults, Pivotal Phase III Study Published in Neurology Finds [news release]. Deerfield, Ill.; BusinessWire: March 25, 2020. https://www.businesswire.com/news/home/20200325005374/en/VYEPTI%E2%84%A2-eptinezumab-jjmr-Demonstrated-Significant-Positive-Impact-Prevention. Accessed March 25, 2020.