Sumatriptan-naproxen and butalbital: a double-blind, placebo-controlled crossover study.

Area of Science:

• Neurology
• Pharmacology
• Clinical Trials

Background:

• Butalbital-containing medications (BCMs) are widely prescribed for migraines despite lacking FDA approval and placebo-controlled efficacy data.
• BCMs are linked to adverse effects, migraine chronification, and medication-overuse headaches.
• This study evaluates the efficacy and safety of Sumatriptan/Naproxen Sodium (SumaRT/Nap) compared to BCMs and placebo.

Purpose of the Study:

• To compare the efficacy of SumaRT/Nap, BCM, and placebo in treating moderate to severe migraine pain.
• To assess sustained pain freedom at 2-24 hours as the primary endpoint.
• To evaluate safety and tolerability across the treatment groups.

Main Methods:

• Randomized, double-blind, double-dummy, 3-attack crossover study in adult migraineurs with prior BCM use.
• Subjects treated three moderate to severe migraines with SumaRT/Nap, BCM, or placebo in a randomized sequence.
• Primary endpoint: sustained pain freedom from 2-24 hours without rescue medication.

Main Results:

• No significant difference in sustained pain-free rates between SumaRT/Nap (8%), BCM (6%), and placebo (3%) at the nominal 0.05 level.
• SumaRT/Nap showed superiority over BCM for pain freedom, pain relief, sustained pain relief, and complete symptom resolution at multiple time points (P≤.044).
• Adverse event incidence was similar across groups (9-12%); nausea was the most frequent event.

Conclusions:

• Despite prior satisfaction with BCMs, subjects reported better outcomes with SumaRT/Nap for migraine pain and associated symptoms.
• SumaRT/Nap use was associated with reduced rescue medication use and longer time to rescue medication compared to BCM and placebo.
• SumaRT/Nap offers a more effective treatment strategy for patients with moderate to severe migraines, particularly those previously treated with BCMs.