Zavzpret safe, provides acute and sustained relief for migraine
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Key takeaways:
- Zavegepant 10 mg nasal spray provided freedom from pain and the most bothersome migraine symptom 2 hours after treatment.
- Pain relief was achieved as early as 15 minutes and lasted 48 hours.
BOSTON — Intranasal Zavzpret was safe and effective for acute treatment of migraine, providing pain relief as early as 15 minutes after administration, according to a presenter at the American Academy of Neurology annual meeting.
“The bottom line is many patients with migraine want a rapid-onset, acute treatment effect,” Richard B. Lipton, MD, director of the Montefiore Headache Center and professor of neurology at Albert Einstein College of Medicine, told attendees. “Not surprisingly, the onset of treatment effect is very much influenced by route of administration.”
Lipton and colleagues sought to compare the safety, efficacy and tolerability of Zavzpret (zavegepant, Pfizer) with placebo in the acute treatment of migraine.
They conducted a phase 3, double-blind, randomized, placebo-controlled trial, which included 1,269 adults (mean age, 41 years; 83% women) with a history of two to eight moderate or severe migraines per month and less than 15 monthly headache days over the past 3 months.
Participants self-administered one dose of 10 mg intranasal zavegepant (n = 623) or placebo (n = 646) to treat one migraine episode and returned to the clinic for an end-of-treatment visit within 7 days.
The coprimary efficacy endpoints were freedom from pain and freedom from the most bothersome symptom (MBS) 2 hours after dosing, with secondary endpoints including pain relief at 15 minutes, return to normal function at 30 minutes and 2 hours, and sustained pain relief 2 to 48 hours after treatment.
According to results, zavegepant was superior to placebo in both primary efficacy endpoints: pain freedom (23.6% vs. 14.9%,) and freedom from the MBS (39.6% vs. 31.1%) 2 hours after treatment.
Data additionally showed zavegepant outperformed the placebo in secondary endpoints of pain relief at 15 minutes (15.9% vs. 8%) and 2 hours (58.7% vs. 49.7%); return to normal function at 30 minutes (10.5% vs. 6.1%) and 2 hours (35.8% vs. 25.6%); and sustained pain relief 2 to 48 hours (36.1% vs. 29.6%) after treatment.
The most common adverse events were dysgeusia (20.5% vs. 4.7%), nasal discomfort (3.7% vs. 0.8%) and nausea (3.2% vs. 1.1%). Most adverse events were mild or moderate, with no serious adverse events reported.
“The exciting thing about zavegepant is that you now have a nonoral option for patients with migraine,” Lipton said. “Given there are a billion people worldwide with migraine, this certainly is not a one-size-fits-all condition.”