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Microsoft word - ahs 07 press release final.docNUPATHE REPORTS POSTIVE PHASE ONE RESULTS FOR NP101
TRANSDERMAL THERAPY FOR ACUTE MIGRAINE
Results presented today at American Headache Society meeting in Chicago show that NuPathe’s SmartRelief™Transdermal Drug Delivery Technology effectively delivers therapeutic levels of sumatriptan over a sustained period
Conshohocken, PA (June 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™ 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®, which is also indicated for the treatment of
The study was a randomized, single-center, single-dose, six-period pilot study to evaluate four
SmartRelief™ prototypes. The study compared sumatriptan pharmacokinetics and safety
following administration of NP101 SmartRelief™ 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, CEO of NuPathe, “Patients need better options for treatment of
acute migraine attacks. Triptans, which are considered the gold standard in treatment today, are
proven to be efficacious, but they often result in inconsistent response, nausea, and recurrent
headaches. Through NuPathe’s patented transdermal delivery system, NP101 is designed to
deliver sumatriptan in a consistent and sustained manner through a patch, significantly reducing
the risk of GI problems.”
Migraine is a widespread, chronic condition that affects approximately 25 million Americans. The
primary symptoms include intense and disabling headache, acute sensitivity to light and sound,
nausea, and aura. Some experts estimate that the loss of productivity associated with migraine
costs the US economy between $13 and $17 billion each year. (1)
Iontophoresis is a non-invasive process for actively transporting drugs through the skin and into
underlying tissue. During iontophoresis charged molecules are propelled through the skin using
bi-polar electrical fields. Iontophoretic products have been approved for multiple medical and
NuPathe specializes in the development of therapeutics for the treatment of neurological and
psychiatric disorders including migraine, Parkinson’s disease and schizophrenia. NuPathe’s lead
product, NP101, uses SmartRelief™, the company’s novel, transdermal patch technology, to
deliver sumatriptan, a widely-used therapy for the treatment of acute migraine. Pending
regulatory review and approval, NP101 would be the first ever migraine treatment based on a
transdermal patch delivery. Phase I clinical results for NP101 have thus far demonstrated rapid
delivery of migraine medication and improved pharmacokinetics compared to current standard of
care. For additional information, visit www.nupathe.com.
(1) Hu XH, Markson LE, Lipton RB, Stewart WF, Berger ML. Burden of migraine in the United
States: disability and economic costs. Arch Intern Med 1999; 159(8):813-818.
For additional information please contact Kim Angelastro at Berry & Company: 212-253-
8881 or send an e-mail to: email@example.com.
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