GSK/Pozen: New Data Fails to Relieve Pain of Trexima Delays
Posted on: Friday, 4 May 2007, 12:00 CDT
With the FDA currently reviewing the response made by GlaxoSmithKline and Pozen to its approvable letter for Trexima, this new data represents an attempt to further differentiate the migraine drug from existing triptans prior to launch. However, the drug's commercial success has already been restricted by approval delays and will be limited further by the impending launch of generic sumatriptan.
New data from more than 1,100 patients presented at the American Academy of Neurology 59th Annual Meeting in Boston show that Trexima (sumatriptan/naproxen sodium) was effective at treating migraine attacks. When taken early, Trexima produced pain-free results at two and four hours, as well as sustained pain-free response 2-24 hours, across individual patients' multiple migraine attacks, demonstrating the consistency in efficacy. Furthermore, nearly one third of all patients were pain free at two hours.
With migraine sufferers frequently citing inconsistent effectiveness as a reason for their dissatisfaction with their medicine, these new data of Trexima demonstrating consistent pain-free results across multiple attacks adds to the anticipation of the drugs approval.
Trexima is an oral fixed dose combination tablet containing the popular migraine triptan therapy, sumatriptan 85mg, together with the anti-inflammatory drug, naproxen sodium 500mg. The drug is currently under review by the FDA for the acute treatment of migraines in adults, although its approval has been delayed. After issuing an approvable letter in June 2006, the FDA requested further safety information on the drug in November. However, the US regulator accepted an amended response to the approvable letter for review in March 2007, and a decision is now expected in August 2007, with a potential launch in the second half of 2007.
Following FDA approval, GSK is expected to aggressively market Trexima in the US. The combination of sumatriptan and naproxen will be marketed as a drug-line improvement and GSK will hope uptake will match this advancement. In the initial three years after launch, Datamonitor predicts Trexima will capture substantial market share from GSK's Imitrex (sumatriptan) and other triptans. However, sales growth will be significantly offset by the US launch of generic sumatriptan, expected in late 2008. As a result, Datamonitor forecasts Trexima sales to peak only two years after launch at $329 million in 2009.
Source: Datamonitor
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