Migraine disease affects close to 37 million Americans. Many Migraineurs use triptans to abort their Migraines quite successfully. For others, oral medications aren't well tolerated because of stomach upset or vomiting. For some Migraineurs, they just take too long to work.
You may remember Teri telling us last year about a new sumatriptan patch being developed, Zelrix. NuPathe has developed a new way of delivering sumatriptan (as in Imitrex), through a transdermal patch placed on the skin. Three important clinical trials of Zelrix have just been completed. This puts Zelrix one step closer to FDA submission later this year.
Zelrix, works to abort a Migraine attack like oral triptans do, but with a different delivery system. The patch uses SmartRelief, TM NuPathe's controlled transdermal delivery system, and administers mild electrical currents which transports the drug Sumatriptan through the skin. This process is called iontophoresis. You can read more about Zelrix in Teri's article, New Zelrix Sumatriptan Patch for Migraine.
Jane Hollingsworth, chief executive officer of NuPathe, commented,
"We are very excited about the results of these three trials. Given the completion of these studies and the continued progress of our ongoing long-term safety studies, we remain on track to submit our New Drug Application (NDA) for Zelrix to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2010."
Mark Pierce, MD PhD, chief scientific officer of NuPathe, said,
"Zelrix was designed specifically to overcome the limitations of current migraine therapies by providing rapid and controlled delivery of sumatriptan while bypassing the need for oral administration and reliance on gastrointestinal absorption. Successful completion of these three studies brings us one step closer to making this important therapy available to the many migraine patients underserved by current treatments. We plan to present detailed results from these studies at an appropriate medical meeting in the future."
This is very exciting news for Migraineurs who have trouble with oral medications. Zelrix has passed the safety trials and is ready for its next step, FDA submission. We can't wait!
PR-Insider.Com. News and Free PR. Business. NuPathe Announces Successful Completion of Three Key Trials for Zelrix(TM) New Drug Application for Zelrix on Track for Submission in Fourth Quarter of 2010. October 11, 2010.
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Last updated October 16, 2010
Published On: October 16, 2010