NuPathe公司向美国FDA递交Zelrix用于治疗偏头痛的的上市申请，这是首个在美国递交上市申请用于偏头痛的贴片。该药是经过缓释处理的舒马曲坦透皮贴剂。

NuPathe表示，将要求与FDA会晤，讨论其关注的问题。

Zelrix是一个递送舒马普坦的贴片，舒马普坦是葛兰素史克的偏头痛药物Imitrex的有效成分。葛兰素史克公司和其他几家公司销售Imitrex的片剂、喷鼻剂及注射剂。

Safeguard Scientifics’ partner company NuPathe submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). The NDA was filed for ZelrixTM, an active, single-use transdermal sumatriptan patch in development for the treatment of migraine. In fact, Zelrix is the first ever submission to the FDA of a transdermal patch for the treatment of migraine.

As NuPathe CEO Jane Hollingsworth stated this morning, “the NDA submission for Zelrix represents a tremendous milestone for NuPathe and the millions of underserved migraine patients.” Migraine affects approximately 28 million adults in the U.S., and in addition to a debilitating headache, most migraine patients suffer from one or more significant gastrointestinal problems, including nausea, vomiting and a compromised ability to digest (aka decreased gastric motility). The nausea and vomiting associated with migraine often makes it difficult for patients to take oral medications, while reduced gastric motility can affect the efficacy of oral medications.

The team at NuPathe designed Zelrix to overcome the limitations of current migraine treatments by avoiding oral administration and controlling the delivery of medication with the company’s SmartReliefTM transdermal technology.

Zelrix was well-tolerated in both the pivotal Phase III trial and the 12 month open label trial, and to date, in the Phase III clinical development program, Zelrix has been evaluated in approximately 800 patients treated for up to one year.
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NuPathe Announces Positive Top-Line Results From 12 Month Safety Trial for Zelrix
NuPathe Inc. announced positive top-line results from a 12 month open-label, safety trial for Zelrix. The company also announces the development of an in vitro analytical testing method for Zelrix, as requested by the U.S. Food and Drug Administration (FDA), to confirm the amount of sumatriptan delivered. Zelrix is a single-use, transdermal sumatriptan patch in development for the treatment of migraine.

"With strong results from this long term, open-label safety trial and the development of an in vitro analytical method for Zelrix, we continue to make steady progress toward the submission of a New Drug Application (NDA) prior to year end," said Jane Hollingsworth, chief executive officer of NuPathe. "Based upon the growing body of clinical evidence, we believe Zelrix, if approved, should provide an efficacious and well-tolerated treatment option for many of the millions of underserved migraine patients in the U.S. in a novel transdermal formulation."

The 12 month study (NP101-008) was an open-label trial designed to assess the long term safety of Zelrix. A total of 183 patients were enrolled and applied at least one Zelrix patch. Importantly, and consistent with findings from the Zelrix Phase III pivotal trial, Zelrix was well tolerated and the incidence of triptan-related adverse events was very low, with only three patients (1.6 percent) reporting a triptan adverse event with any Zelrix treatment over the course of the 12 month trial.

The most common adverse events were related to the patch application site and included application site itching (21.9 percent of patients), application site pain (21.3 percent) and application site hypersensitivity (6.0 percent). During the 12 month trial, 25 patients (13.7 percent) discontinued participation due to adverse events, which were primarily due to application site reactions. There was no observed increase in skin irritation with successive or cumulative patch usage.

In addition to assessing safety, this trial evaluated patients' efficacy responses two hours after application of Zelrix when treating a migraine with headache pain rated moderate to severe. Efficacy highlights include:

Achievement of headache pain relief within two hours for 58 percent of migraines treated

Achievement of headache pain freedom within two hours for 24 percent of migraines treated

Achievement of freedom from nausea within two hours for 79 percent of migraines treated

Rescue medication used in only 19 percent of migraines treated

"The safety and tolerability of Zelrix in this 12 month trial was consistent with the profile observed in the pivotal Phase III trial for Zelrix in which only a single migraine was treated," commented Mark Pierce, MD, PhD, chief scientific officer of NuPathe. "Additionally, the results demonstrate strong and consistent efficacy throughout the duration of the trial." NuPathe plans to present detailed results from the trial at a scientific meeting in 2011.