Zelrix, a Novel Transdermal Patch for Migraine, Found to Provide Rapid, Consistent, and Sustained Relief for Migraine Sufferers in Phase III Trial

Achieves Statistical Significance on Primary Endpoint and All Key Secondary
Endpoints
PHILADELPHIA--(Business Wire)--
NuPathe Inc., a specialty pharmaceutical company developing innovative products
for the treatment of neurological and psychiatric diseases, today announced data
from the pivotal Phase III trial of Zelrix, a novel transdermal patch in
clinical development for the treatment of acute migraine. Zelrix combines
NuPathe`s proprietary SmartRelief iontophoretic transdermal technology with
sumatriptan, the most prescribed treatment for acute migraine in the United
States. The Phase III trial was conducted in 530 adults and was administered in
a multi-center, randomized, parallel group, double-blind, placebo-controlled
trial, where efficacy and tolerability of Zelrix were compared with placebo.

Zelrix met the primary efficacy endpoint of a statistically significant
improvement compared to placebo for pain freedom at two hours after patch
application (18 percent vs. 9 percent, p=0.0092). Additional pre-defined two
hour efficacy endpoints included:

* Pain relief: 53 percent of patients treated with Zelrix compared with 29
percent for placebo (p<0.0001);
* Nausea free: 84 percent of patients treated with Zelrix compared with 63
percent for placebo (p<0.0001);
* Photophobia free: 51 percent of patients treated with Zelrix compared with 36
percent for placebo (p=0.0028);
* Phonophobia free: 55 percent of patients treated with Zelrix compared with 39
percent for placebo (p=0.0002).

In addition to meeting the primary and key secondary endpoints, Zelrix
demonstrated rapid efficacy and sustained pain relief with lower use of rescue
medication:

* Pain relief within one hour: 29 percent of patients treated with Zelrix
compared with 19 percent for placebo (p=0.0135);
* Nausea free within one hour: 71 percent of patients treated with Zelrix
compared with 58 percent for placebo (p=0.0251);
* Sustained pain relief (from two to 24 hours): 34 percent of patients treated
with Zelrix compared with 21 percent for placebo (p=0.0015);
* Use of rescue medication: 40 percent of patients treated with Zelrix compared
with 60 percent for placebo (p<0.0001).

Zelrix was well-tolerated in the clinical trial. Skin tolerability was typical
of other transdermal products with mild to moderate erythema present upon patch
removal. The incidence of triptan-specific adverse events was very low (2
percent for Zelrix). The most common adverse event was application site pain,
having been reported by 23 percent of patients with Zelrix compared to 15
percent with placebo. The next most common adverse event was application site
tingling, with 12 percent reported with Zelrix compared to 19 percent with
placebo. The majority of adverse events were reported as mild and transient.

"The Zelrix patch is a highly-effective, well tolerated, non-oral treatment for
migraine," said Jerome Goldstein, MD, founder of the Headache and Facial Pain
Section of the American Academy of Neurology and Director of the San Francisco
Headache Clinic and Clinical Research Center. "Treatment-altering nausea,
medication side effects, and inconsistent drug absorption are common problems
that prevent many patients from effectively treating their migraines. The data
from the clinical trial indicates that Zelrix could benefit many migraine
patients."

"Transdermal delivery has been recognized as an ideal approach to treating
migraine, but has not been achieved to date," said Jane Hollingsworth, chief
executive officer of NuPathe. "Using NuPathe`s SmartRelief technology, Zelrix is
poised to be the first and only transdermal patch approved for the treatment of
acute migraine. This breakthrough is an important milestone for NuPathe and
millions of migraine sufferers. We plan to file an NDA for Zelrix in 2010 and
look forward to bringing this important innovation to patients."

NuPathe will present Phase III data at the 14th Congress of the International
Headache Society in Philadelphia on Friday, Sept. 11, 2009 at 1:15 p.m. EDT and
on Saturday, Sept. 12, 2009 at 11:45 a.m. EDT.

About Zelrix

Zelrix is a novel migraine therapy in clinical development for the treatment of
acute migraine. If approved for marketing, Zelrix would be the first and only
transdermal patch for migraine patients. Zelrix utilizes a proprietary
state-of-the-art transdermal delivery system, SmartRelief, to deliver
sumatriptan, the most widely prescribed migraine therapy in the United States,
in a rapid but controlled manner.

Zelrix was designed to address key limitations of existing therapies. Oral
therapies are often difficult to take when patients are nauseated during
migraine attacks and can lead to inconsistent efficacy. In addition, side
effects associated with peak plasma concentrations limit patients` ability or
willingness to take certain treatments. Based upon clinical results to date,
Zelrix could offer patients a treatment that allows them to treat their migraine
on time every time, regardless of gastrointestinal symptoms, in a well-tolerated
manner. NuPathe expects to submit an NDA for Zelrix in 2010.

About SmartRelief

SmartRelief is a proprietary iontophoretic system combining modern electronics
with state-of-the-art formulation and pharmaceutics technology. Iontophoresis is
a non-invasive method for transporting a molecule through the skin by means of a
mild electrical current. The electrical current carries the charged molecule
from the patch across the skin. Once across, the drug is rapidly absorbed by the
microvascular and distributed systemically.

About Migraine

Migraine is an episodic headache disorder associated with various combinations
of neurologic, gastrointestinal, and autonomic symptoms that affects
approximately 28 million Americans, mostly women. Common symptoms of migraine
include recurrent headaches, nausea, vomiting, photophobia (sensitivity to
light) and phonophobia (sensitivity to sound).

According to the National Headache Foundation, 55 percent of migraine sufferers
frequently experience nausea as part of their migraine attacks commonly
resulting in patients delaying, modifying, or skipping treatment. Concerns about
treatment-related side effects also lead patients to delay, modify, or skip
treatment in over one-third of migraine attacks. Moreover, many patients
experience inconsistent relief, which experts attribute, in part, to substantial
variation in oral drug absorption.

About NuPathe

NuPathe Inc. is a specialty pharmaceutical company developing innovative
therapeutic products for the treatment of neurological and psychiatric diseases.
NuPathe`s mission is to identify and address the needs of patients that are
insufficiently met by current treatments. NuPathe`s product portfolio includes
Zelrix which, if approved, would be the first and only transdermal patch for the
treatment of acute migraine, and NP201, a long acting injectable implant for the
treatment of Parkinson`s disease. Please visit NuPathe`s web site at
www.nupathe.com.

MEDIA CONTACTS
Theresa Murray
610-642-8253 x164
Theresa@GregoryFCA.com
or
NuPathe Inc.
Jerry McLaughlin
Vice President, Commercial Operations
484-567-0130 ext.1111

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