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Trial: Sumatriptan Succinate/Naproxen Sodium Combo Delivers Consistent Efficacy From Multiple Migraines
Trexima, the proposed brand name for a single tablet containing sumatriptan 85 mg as the succinate salt, formulated with RT Technology(TM), and naproxen sodium 500 mg, is currently under review by the United States Food and Drug Administration (FDA) for the acute treatment of migraines in adults.
"While current therapies may be efficacious for many patients, we know that consistency across migraine attacks continues to be a problem for some," said Richard Lipton, MD, professor of Neurology, Epidemiology and Social Medicine, Albert Einstein College of Medicine in New York. "These study results are significant because they demonstrated that treatment with this therapy was consistent across multiple attacks in a large number of patients."
The desire for treatments that better meet migraine patients' needs was underscored in other data presented at the Symposium. The Migraine Assessment of Current Therapy (ACT), an office-based questionnaire, was administered to 418 migraine patients to assess whether their medication works consistently, relieves pain within two hours, allows normal functioning within two hours, and enables enough comfort to plan daily activities. Respondents were categorized by primary therapy, including triptans, barbiturates, opioids, prescription NSAIDs or OTC analgesics, isometheptene, dichloralphenazone, and acetaminophen (IDA) combinations, and other. Results showed that while patients taking triptans had the best responses, there is still room for improvement.
About the Studies
Consistent Efficacy Across Four Migraine Attacks
Two identical cross-over clinical trials were conducted in adults with multiple migraine attacks. The trials were randomized, multi-center, double- blind, placebo-controlled, and utilized early intervention (treating mild migraine pain and within one hour of the start of pain).
Subjects were randomized to one of five treatment sequences and instructed to treat four migraine attacks. Patients in four groups received sumatriptan/naproxen sodium in three of four attacks and placebo in the remaining attack. Patients in the fifth group received sumatriptan/naproxen sodium for all four attacks. The primary analyses used repeated measures techniques across attacks for both pain severity at two hours and sustained through 24 hours (co-primaries).
In the first consistency study:
- Five hundred and seventy (570) patients treated 1,693 attacks with sumatriptan/naproxen sodium and 424 attacks with placebo.
- The percentage of patients who were pain free at two hours was 52 percent and 25 percent (p The percentage of patients who were sustained pain free at 24
hours was 37 percent and 17 percent (p
In the second consistency study:
- Five-hundred and sixty-five (565) patients treated 1,678 attacks with sumatriptan/naproxen sodium and 422 attacks with placebo.
- The percentage of patients who were pain free at two hours was 50 percent and 20 percent (p The percentage of patients who were sustained pain free at 24 hours was 34 percent and 12 percent (p
Adverse events were generally mild with the most common being dry mouth, nausea, and dizziness across all attacks treated in both studies. No serious drug-related adverse events were reported.
Source: POZEN; GlaxoSmithKline