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NuPathe Reports Positive Phase One Results for NP101 Transdermal,Therapy for Acute Migraine

CONSHOHOCKEN, Pa.--(BUSINESS WIRE)--Jun 8, 2007 - NuPathe Inc., a privately held specialty pharmaceutical company, today announced positive results from an initial Phase I study of NP101 SmartRelief, a novel treatment for acute migraine being developed by NuPathe.

NP101 combines NuPathe's SmartRelief(TM) proprietary iontophoretic transdermal technology with sumatriptan, the most widely prescribed treatment for acute migraine in the United States. Sumatriptan is also the active ingredient in IMITREX(R), which is also indicated for the treatment of acute migraine.

The study was a randomized, single-center, single-dose, six-period pilot study to evaluate four SmartRelief(TM) prototypes. The study compared sumatriptan pharmacokinetics and safety following administration of NP101 SmartRelief(TM) prototype patches, IMITREX 50 mg tablets, and IMITREX 6 mg subcutaneous injection. Results of the Phase I study were presented today in a poster presentation at the American Headache Society meeting in Chicago.

In the study, NP101 maintained continual therapeutic dosing levels of sumatriptan an average of four times longer than treatment with the 6 mg injection of IMITREX and up to twice as long as treatment with the 50 mg tablet of IMITREX. NP101 was also generally well tolerated.

"These results demonstrate that NuPathe's transdermal technology can deliver therapeutic drug levels quickly and then maintain those levels over a sustained period of time, which may significantly improve consistency of response and decrease frequency of recurrent migraines in patients," said Steven J. Siegel, MD, PhD, assistant professor, University of Pennsylvania, who presented the results in Chicago. "This controlled delivery option could represent an important alternative for patients who experience gastrointestinal disorders such as nausea and vomiting during their migraine attack."

According to Jane Hollingsworth
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