NuPathe to Present ZECUITY Data at the 2013 International Headache Congress

NuPathe to Present ZECUITY Data at the 2013 International Headache Congress 
Data Analyses to Be Presented Include: 
Efficacy of ZECUITY in Migraine Patients With and Without Nausea at
Baseline 
Incidence of Treatment-Emergent Nausea During a Migraine Treated With
ZECUITY Compared With Patients Treated With a Placebo Patch 
Assessment of Migraine Patients' Ability to Correctly and Easily
Assemble, Apply and Activate ZECUITY During an Attack 
CONSHOHOCKEN, PA -- (Marketwired) -- 06/26/13 --  NuPathe Inc.
(NASDAQ: PATH) today announced the Company will present data on
ZECUITY(R) (sumatriptan iontophoretic transdermal system) at the
upcoming International Headache Congress (IHC) 2013, which takes
place June 27 to 30 in Boston, MA. 
The posters will be on display as of 11:30 am on Thursday, June 27,
2013, in Hall D of the John B. Hynes Veterans Memorial Convention
Center and are as follows: 
"Efficacy of the Sumatriptan Iontophoretic Transdermal System
(ZECUITY(R)) Is Similar in Migraine Patients with and without Nausea
at Baseline"
 This was a post-hoc analysis of the randomized,
parallel-group, double-blind, placebo-controlled Phase 3 clinical
trial data to compare the efficacy of ZECUITY in relieving migraine
headache pain and associated symptoms in patients who had nausea at
baseline compared with patients who did not report nausea as a
symptom at baseline. Patients who had migraine-related nausea (MRN)
at the time of treatment were nearly twice as likely to report their
headache pain as "severe" than those without MRN at the time of
treatment (31% vs. 16%). The data showed that ZECUITY was efficacious
in treating migraine headache pain and associated symptoms regardless
of the presence of nausea prior to treatment. 
Presenters will be available to answer questions on Friday, June 28,
from 10:30 am to noon and from 3:45 to 4:45 pm. All times are local
(EDT). 
"Sumatriptan Transdermal System (TDS) Is Associated with
Substantially Less Treatment Emergent Nausea than Placebo"
 This was
a post-hoc analysis of the randomized, parallel-group, double-blind,
placebo-controlled Phase 3 clinical trial data to compare the
incidence of treatment-emergent nausea two hours after patch
activation in patients treated with ZECUITY or placebo who were
nausea free at the beginning of treatment. The data showed that at
two hours following patch activation, patients treated with a placebo
patch (13.8%) were three times more likely to have treatment-emergent
nausea as those treated with ZECUITY (4.6%). In addition, the data
showed that the incidence of treatment-emergent nausea with ZECUITY
was lower than placebo from one hour through 24 hours following patch
activation.  
Presenters will be available to answer questions on Friday, June 28,
from 10:30 am to noon and on Saturday, June 29, from 3:45 to 4:45 pm.
All times are local (EDT). 
"Sumatriptan Transdermal System (TDS) Can Be Correctly Assembled,
Applied and Activated during Migraine Attacks"
 This was a
single-center, open-label study assessing a single use of ZECUITY in
48 adults including 32 migraine patients and 16 healthcare
professionals to validate the ability to easily assemble, apply and
activate ZECUITY. All of the migraine patients and healthcare
professionals safely and successfully assembled, applied and
activated ZECUITY. In addition, the subjects were asked to rate this
process on a scale of 1 to 7, with 1 being difficult and 7 being
easy. The average rating for ease of assembly was 6.1 out of 7 and
for ease of application and assembly was 6.8 out of 7.  
Presenters will be available to answer questions on Friday, June 28,
from 10:30 am to noon and on Saturday, June 29, from 3:45 to 4:45 pm.
All times are local (EDT). 
"These additional data show that ZECUITY is an easy-to-use new
treatment option that is particularly well-suited for the millions of
migraine patients who frequently suffer from debilitating
migraine-related nausea along with their headache pain during an
attack," said Mark Pierce, MD, PhD, chief scientific officer of
NuPathe. "Patients report that during a migraine attack, the symptom
of migraine-related nausea can be as debilitating as headache pain
itself, and treatments that bypass the GI tract may be the best way
to treat these patients." 
About Zecuity 
 ZECUITY (sumatriptan iontophoretic transdermal
system) (patch) is indicated for the acute treatment of migraine with
or without aura in adults. Zecuity is a single-use, battery-powered
patch applied to the upper arm or thigh during a migraine. Following
application and with a press of a button, Zecuity initiates
transdermal delivery (through the skin), bypassing the
gastrointestinal tract. Throughout the four-hour dosing period, the
microprocessor within Zecuity continuously monitors skin resistance
and adjusts drug delivery accordingly to ensure delivery of 6.5 mg of
sumatriptan, the most widely prescribed migraine medication, with
minimal patient-to-patient variability.  
Important Safety Information 
 Patients should not take ZECUITY if
they have heart disease, a history of heart disease or stroke,
peripheral vascular disease (narrowing of blood vessels to your legs,
arms, stomach or kidney), transient ischemic attack (TIA) or problems
with blood circulation, uncontrolled blood pressure, migraines that
cause temporary paralysis on one side of the body or basilar
migraine, Wolff-Parkinson-White syndrome or other disturbances of
heart rhythm. Very rarely, certain people, even some without heart
disease, have had serious heart-related problems after taking
triptans like ZECUITY.  
Patients should not use ZECUITY if they have taken other migraine
medications such as ergotamine medications or other triptans in the
last 24 hours or if they have taken monoamine oxidase-A (MAO-A)
inhibitors within the last 2 weeks. 
Patients should not use ZECUITY during magnetic resonance imaging
(MRI). 
Patients should not use ZECUITY if they have an allergy to
sumatriptan or components of ZECUITY or if they have had allergic
contact dermatitis (ACD) following use of ZECUITY. If patients
develop ACD, they should talk to their healthcare provider before
using sumatriptan in another form. 
ZECUITY, like other triptans, may be associated with a potentially
life-threatening condition called serotonin syndrome, mainly when
used together with certain types of antidepressants including
serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine
reuptake inhibitors (SNRIs).  
Patients should tell their healthcare provider before using ZECUITY
if they have heart disease or a family history of heart disease,
stroke, high cholesterol or diabetes; have gone through menopause;
are a smoker; have had epilepsy or seizures or if they are pregnant,
nursing or thinking about becoming pregnant.  
The most common side effects of ZECUITY are application site pain,
tingling, itching, warmth and discomfort. Most patients experience
some skin redness after removing ZECUITY. This redness typically goes
away in 24 hours.  
Please see full Prescribing Information for ZECUITY. 
Patients are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call
1-800-FDA-1088. 
Patients and healthcare providers interested in more information on
Zecuity should visit www.zecuity.com. 
About Migraine and Migraine-Related Nausea (MRN)
 Migraine is a
debilitating neurological disease afflicting a large underserved
patient population. Migraine is characterized by headache pain
accompanied by associated neurological and GI symptoms including
nausea, vomiting, photophobia, and phonophobia.(1,2) In the U.S., 31
million adults, with approximately three times as many women as
men,(3) suffer from migraine.(3,4,5) Of the 16 million migraine
patients who are diagnosed and treated, approximately eight million
experience migraine-related nausea (MRN) in at least half of their
migraine attacks.(6) These frequent-MRN patients report significantly
more migraine symptom burden and experience significantly more
interference with work, social and family life.(6) Many migraine
patients who experience MRN delay or avoid taking orally administered
medications due to nausea or vomiting.(7) 
About NuPathe
 NuPathe Inc. is a specialty pharmaceutical company
focused on innovative neuroscience solutions for diseases of the
central nervous system including neurological and psychiatric
disorders. NuPathe's lead product, Zecuity (sumatriptan iontophoretic
transdermal system), has been approved by the FDA for the acute
treatment of migraine with or without aura in adults. Zecuity is
expected to be available by prescription in the fourth quarter of
2013. In addition to Zecuity, NuPathe has two proprietary product
candidates based on its LAD(TM), or Long-Acting Delivery,
biodegradable implant technology that allows delivery of therapeutic
levels of medication over a period of months with a single dose.
NP201, for the continuous symptomatic treatment of Parkinson's
disease, utilizes a leading FDA-approved dopamine agonist,
ropinirole, and is being developed to provide up to two months of
continuous delivery. NP202, for the long-term treatment of
schizophrenia and bipolar disorder, is being developed to address the
long-standing problem of patient noncompliance by providing three
months of continuous delivery of risperidone, an atypical
antipsychotic. NuPathe is actively seeking partnerships to maximize
the commercial potential for Zecuity and its other product candidates
in the U.S. and territories throughout the world. 
For more information about NuPathe, please visit our website at
www.nupathe.com. You can also follow us on StockTwits
(stocktwits.nupathe.com), Twitter (twitter.nupathe.com), SlideShare
(slideshare.nupathe.com) and LinkedIn (linkedin.nupathe.com). 
Cautionary Note Regarding Forward-Looking Statements 
 This press
release contains "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995. All statements
that are not historical facts are hereby identified as
forward-looking statements for this purpose and include, among
others, statements relating to: the potential benefits of, and
commercial opportunity for, ZECUITY and NuPathe's other product
candidates; partnering plans for ZECUITY and NuPathe's other product
candidates; and the timing of the expected launch and availability of
ZECUITY. Forward-looking statements are based upon management's
current expectations and beliefs and are subject to a number of
risks, uncertainties, assumptions and other factors that could cause
actual results and events to differ materially from those indicated
herein including, among others: NuPathe's ability to obtain
sufficient capital to launch ZECUITY; NuPathe's ability to obtain
commercial and development partners for ZECUITY and its other product
candidates; NuPathe's reliance on third parties to manufacture
ZECUITY; NuPathe's ability to establish and effectively manage its
supply chain; NuPathe's ability to establish effective marketing and
sales capabilities; market acceptance among physicians and patients
and the availability of adequate reimbursement from third party
payors for ZECUITY; and the risks, uncertainties and other factors
discussed in NuPathe's Annual Report on Form 10-K for the year ended
December 31, 2012 under the caption "Risk Factors" and elsewhere in
such report, which is available on NuPathe's website at
www.nupathe.com in the "Investor Relations -- SEC Filings" section.
While NuPathe may update certain forward-looking statements from time
to time, it specifically disclaims any obligation to do so, whether
as a result of new information, future developments or otherwise. You
are cautioned not to place undue reliance on any forward-looking
statements. 
References
 1. ICHD-II. Cephalagia 2004; 24 (Suppl 1).  
2. Lipton, R. et al. Classification of primary headaches. Neurology.
2004:63:427-435. 
 3. Lipton, R. et al. Prevalence and Burden of
Migraine in the United States: Data From the American Migraine Study
II. Headache, July/August 2001: p. 646. 
 4. US Census Data. 1999,
accessed at http://www.census.gov/prod/2001pubs/p23-205.pdf 01/03/13;
and 2010, accessed at http://www.census.gov/2010census/data/. 
 5.
NuPathe Analysis. 
 6. Lipton, R. et al. "Frequency and Burden of
Headache-Related Nausea: Results from the American Migraine
Prevalence and Prevention (AMPP) Study." Headache 2012:53:93-103.
Funded by a research grant from NuPathe Inc. 
 7. Silberstein, S.
Migraine symptoms: results of a survey of self-reported migraineurs.
Headache 1995;35:387-396.  
INVESTOR CONTACTS
Westwicke Partners
John Woolford
(443) 213-0506
john.woolford@westwicke.com 
Keith A. Goldan
Vice President, Chief Financial Officer
NuPathe Inc.
(484) 567-0130 
MEDIA CONTACT:
Sage Strategic Marketing
Jennifer Guinan
(610) 410-8111
jennifer@sagestrat.com 
 
 
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