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Title: Sumatriptan/Naproxen Rapid Release Provides Rapid and Sustained Efficacy in Migraineurs With Severe Pain: Presented at IHS

"Sumatriptan/Naproxen Rapid Release Provides Rapid and Sustained Efficacy in Migraineurs With Severe Pain: Presented at IHS"

By Claire Sowerbutt KYOTO, JAPAN -- October 18, 2005 -- Data on the efficacy of the new, single-tablet formulation of rapid release sumatriptan and naproxen sodium (SumaRT/NAP) in migraineurs with severe pain, show significant efficacy in 2- to 24-hour sustained pain-free responses compared with either agent administered alone, and compared with placebo. The study was in fact 2 studies designed to address 6 coprimary endpoints per study. "This trial was designed to address not only pain but also the associated symptoms of nausea and phono/photophobia that are so troublesome for so many migraineurs," said Dr. Jan Brandes, MD, neurologist, Nashville Neuroscience Group, Nashville, Tennessee. Dr. Brandes presented the data here October 12[^th during the 12^th Congress of the International Headache Society (IHS).

The first study randomized 1736 migraineurs, with data on 1470 available for the intent-to-treat (ITT) analysis. The second study randomized 1677 migraineurs, with data from 1441 available for the ITT analysis. Subjects had experienced migraine for nearly 2 decades and were predominantly Caucasian women of approximately 40 years of age.

The ITT population included participants who recorded moderate to severe pain at baseline, who provided at least 1 postdose assessment of the effects of the study medication. Therapeutic gain was determined as the active response less the placebo effect.

"When we look at the attacks that were treated, severe pain was somewhat higher than that seen in some of the earlier sumatriptan trials. When thinking about being able to treat these attacks, and achieve a 2- to 24-hours pain-free response, this endpoint becomes all the more meaningful," Dr. Brandes said.

Results show a 16% therapeutic gain among patients who used the combination medication in the first study, and 17% in the second study (P < .001 for both). In 1 study SumaRT/NAP showed significant efficacy in reducing nausea compared with either agent alone (P < .001). Among patients taking naproxen alone, 4% achieved a 2- to 24-hour sustained pain-free response in the first study, compared with 8% in the sumatriptan group.

"It would appear that there is something about the combination that produces a possible synergistic effect, translating into greater therapeutic gain in these patients," Dr. Brandes said.

"When we look at safety, the side effects are close to results seen in other studies," she said.

"Overall, the data for the combination show statistical difference on the outcomes of pain, photo-, and phonophobia [P < .001 vs SumaRT, NAP, and placebo] and when the trials are combined, there is statistical improvement in nausea [P < .005 vs SumaRT, NAP, and placebo]," Dr. Brandes said.

"In the most difficult parameter -- 2- to 24-hour pain-free response -- both studies showed statistical superiority for the combination product over either of the component products alone [P < .001]," she said.

[Presentation title: Therapeutic Clinical Benefits of a New Single-Tablet Formulation of Sumatriptan Formulated With RT Technology and Naproxen Sodium. Session 6]

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