Speaking of POZN, this PR was released today:
Press Release Source: POZEN; GlaxoSmithKline
New Analysis Shows Patients Who Treat Their Migraine Pain Early With Trexima(TM) (Sumatriptan Succinate/Naproxen Sodium) Have Higher Sustained Pain-Free Rates Than Those Who Treat Late
Wednesday September 20, 9:22 am ET
Patients Who Treated Early Were More Likely to be Pain-free from 2 Through 24 Hours
LONDON, Sept. 20 /PRNewswire-FirstCall/ -- (NYSE: GSK - News; Nasdaq: POZN - News) -- Migraine sufferers frequently cite lack of recurrence of migraine symptoms as one of the most desired attributes of an acute migraine treatment. Now, a new analysis of four studies showed that patients who treated their migraines with Trexima while pain was mild and within one hour of the start of pain were nearly twice as likely to be pain free at 2 hours, and remain pain free through 24 hours, than those who waited until the pain was more severe. These findings were presented today at the 16th Migraine Trust International Symposium in London.
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"Patients are often hesitant to treat their migraine early as they are concerned that the medicine will wear off and their symptoms will return. These results are exciting because they may help dispel this myth." said Jan Lewis Brandes, MD, director of the Nashville Neurosciences Institute and lead study investigator. "These findings show that by treating a migraine early with a product like Trexima patients are more likely to still be pain free 24-hours later than if they wait to treat in the later stages of a migraine."
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 500mg, is currently under review by the United States Food and Drug Administration (FDA) for the acute treatment of migraines in adults.
Migraine pain is believed to be induced not only by the widening of blood vessels, or vasodilation, but also by inflammation, leading to increased nociception (perception of pain) and sensitization of nerves. This complex sequence of events occurs long before patients feel pain and take their medication.
About the Studies
Data were derived from identical, randomized, multi-center, double-blind, placebo controlled studies. This analysis evaluated sustained pain-free responses, defined as pain free at 2 hours and maintained through 24 hours, in these studies.
Two studies evaluated the clinical benefits of treating migraine early (while pain was mild and within one hour of the start of pain) with sumatriptan/naproxen sodium or placebo. These findings showed:
-- Significantly more patients who treated with sumatriptan/naproxen
sodium achieved a sustained pain-free response (45 percent and
40 percent) compared to patients who received placebo (12 percent and
14 percent).
Two studies evaluated the benefits of treating migraine late (when pain is moderate to severe) with sumatriptan/naproxen sodium; 85 mg of sumatriptan, formulated with RT Technology; 500 mg of naproxen sodium; or placebo.
-- Significantly more patients who treated with sumatriptan/naproxen
sodium achieved a sustained pain-free response (23 percent and
25 percent) compared to patients who treated with sumatriptan alone
(14 percent and 16 percent), naproxen sodium alone (10 percent and
10 percent), or placebo (7 percent and 8 percent).1
Sumatriptan/naproxen sodium was well-tolerated in all four studies. The most common adverse events were dizziness, somnolence, nausea, tingling, dry mouth, dyspepsia, and chest discomfort.
Of course patients would likely do even better if they could manage the hard task of taking two Alleve tabs (which is nearly 500mg of Naproxen) and one of the second-generation triptans...
Peter |
