NuPathe Doses Adolescent Migraineurs in Clinical Study of ZECUITY

NuPathe Doses Adolescent Migraineurs in Clinical Study of ZECUITY 
Phase 1, Open Label, Single-Dose Safety, Pharmacokinetic, and
Tolerability Study of ZECUITY in Adolescents 
CONSHOHOCKEN, PA -- (Marketwired) -- 09/23/13 --  NuPathe Inc.
(NASDAQ: PATH) today announced the Company has initiated dosing of
patients for NP101-015, a Phase 1 study of ZECUITY(R) (sumatriptan
iontophoretic transdermal system) in adolescents with a history of
migraine attacks. This open label, single-dose study will assess the
safety, pharmacokinetics, and tolerability of ZECUITY in adolescent
migraine patients. ZECUITY was approved by the U.S. Food and Drug
Administration (FDA) in January 2013 for the acute treatment of
migraine with or without aura in adults and is the first and only
FDA-approved patch for the treatment of migraine. This study is part
of the Company's post-marketing requirem
ents. 
Migraine Treatment in Adolescents
 Oral tablets are the only route of
administration currently approved for the acute treatment of migraine
attacks in adolescents.(1,2) An analysis of the landmark American
Migraine Prevalence and Prevention Study (AMPP), the largest survey
of migraine sufferers, showed that 5.0% of boys and 7.7% of girls
aged 12 to 19 met the ICHD-2 criteria for migraine.(3) Adolescents
experience the same cardinal symptoms of migraine as do adults:
headache pain, migraine-related nausea, photophobia and phonophobia.
As reported in a retrospective review of Glaxo Wellcome (now
GlaxoSmithKline) adolescent clinical trials database (N = 1,952), 53%
of adolescent patients experienced nausea.(4) 
Study Overview
 Up to 36 adolescents, aged 12 to 17, will participate
in the trial. Patients will have a history of acute migraine attacks
but will be otherwise healthy. There will be a similar number of
subjects between 12 to 14 years of age and 15-17 years of age with
distribution of both sexes in each age bracket. The primary
objectives of the study are to: 


 
--  Determine the safety and tolerability of a single dose of ZECUITY in
    adolescent subjects with a history of acute migraine
--  Determine the pharmacokinetics of sumatriptan in adolescent subjects
    when delivered by ZECUITY's transdermal route of administration

  
Results of this study are expected in July 2014
.  
"Adolescents have limited options to treat their migraine symptoms,"
said Mark Pierce, MD, PhD, chief scientific officer of NuPathe.
"Because ZECUITY is an easy-to-use new treatment option that bypasses
the gastrointestinal tract, it may be particularly well-suited for
adolescent migraine patients who frequently suffer from debilitating
migraine-related nausea along with their headache pain during an
attack." 
About ZECUITY 
 ZECUITY 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.(5,6) In the U.S., 31
million adults, with approximately three times as many women as
men,(7) suffer from migraine.(7,8,9) 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.(10) These frequent-MRN patients report
significantly more migraine symptom burden and experience
significantly more interference with work, social and family
life.(10) Many migraine patients who experience MRN delay or avoid
taking orally administered medications due to nausea or vomiting.(11) 
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 timing of the availability of the
results of the referenced study; the potential benefits and safety of
ZECUITY for adolescents; 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: risks and uncertainties relating to the
completion and outcome of clinical trials; 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. US Prescribing Information Maxalt(R) (rizatriptan benzoate),
Tablets. 
 2. US Prescribing Information Axert(R) (almotriptan),
Tablets. 
 3. Bigal, M. et al. Migraine in adolescents: Association
with socioeconomic status and family history. Neurology, July 3,
2007; 69: 16-25. 
 4. Winner, P., Rothner, AD., Putnam, DG., et al,
Demographic and migraine characteristics of adolescents with
migraine: Glaxo Wellcome clinical trials database, Headache 2003 May
43(5):451-7. 
 5. ICHD-II. Cephalagia 2004; 24 (Suppl 1). 
 6.
Lipton, R. et al. Classification of primary headaches. Neurology.
2004:63:427-435. 
 7. 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. 
 8. 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/. 
 9.
NuPathe Analysis. 
 10. 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. 
 11. Silberstein, S.
Migraine symptoms: results of a survey of self-reported migraineurs.
Headache 1995;35:387-396.  
Contact Information:  
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:
Sam Brown Inc.
Mariesa Kemble
(608) 850-4745
mariesak@sambrown.com 
 
 
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