15 Jan NuPathe Continues to Pursue Development of Zelrix
In the first half of this year, the pharmaceutical company NuPathe Inc. plans to resubmit its new drug application to the U.S. Food and Drug Administration (FDA) for Zelrix, a transdermal sumatriptan patch intended to treat migraine.
The company had hoped to launch the new product in that time frame, but the FDA raised concerns in mid-2011 about the chemistry, manufacturing and safety of Zelrix, slowing the product’s release.
In November, NuPathe representatives met with FDA officials about their concerns.
According to NuPathe Chief Executive Jane Hollingsworth, the meeting was productive.
“Based on this discussion we have a clear understanding and plan to address the remaining issues required for approval and now intend to submit our (new drug application) in the first half of 2012,” she said, “We will use the time between now and approval to continue to launch preparation, including our efforts to broaden physicians’ awareness of the burden of migraine-related nausea.”
Zelrix is reported to offer fast and sustained pain relief through a process called iontophoresis, in which a slight electrical current transports medication through skin. The benefit of a patch, NuPathe officials say, is that it bypasses the gastrointestinal system.
This is important, they note, because nausea and the fear of it makes it difficult for many patients to take oral medications, and when they do, reduced gastric motility associated with the migraine may reduce medications’ efficacy.
In addition to pain, Zelrix is reported to alleviate other cardinal symptoms of migraine, including nausea and sensitivity to light and sound.