
NuPathe Inc. graphics superimposed.
NuPathe's Zecuity Approved by the FDA for the
Acute Treatment of Migraine With New Delivery System for the Patient
CONSHOHOCKEN,
PA— SUNDAY, JANUARY 27th , 2013 — (MAGNUM)
— According to Marketwire on January 17th NuPathe Inc. (NASDAQ:
PATH) announced that the U.S. Food and Drug
Administration (FDA) had approved Zecuity™ (sumatriptan iontophoretic
transdermal system) for the acute treatment of Migraine with or without aura in
adults. Zecuity is a single-use, battery-powered patch that actively delivers
sumatriptan, the most widely prescribed Migraine abortive medication, through
the skin. Zecuity provides relief of both Migraine head pain and
migraine-related nausea (MRN).
"The approval of Zecuity represents a major milestone for
NuPathe and Migraine sufferers," said Armando Anido, CEO of NuPathe. "As the
first and only FDA-approved Migraine patch, we believe Zecuity will be a
game-changing treatment option for millions of migraine patients, especially
those with Migraine-related nausea. We thank the patients and physicians who
participated in our clinical trials as well as our employees for their support
throughout the development of Zecuity. We now intensify our focus to securing
commercial partners and preparing for the launch of Zecuity expected in the
fourth quarter of this year."
"In addition to severe [Migraine] pain, Migraine patients
present with other significant symptoms, which commonly includes Migraine-related
nausea," said Lawrence C. Newman, MD, FAHS, FAAN, Director of the Headache
Institute at St. Luke's-Roosevelt Hospital in New York. "For these
patients, physicians need to assess and offer treatments tailored to each
individual patient's array of Migraine symptoms. In fact, the American Academy
of Neurology guidelines recommend a non-oral route of administration for Migraineurs
who experience nausea or vomiting as significant symptoms."
"Migraine-related nausea can be as debilitating as Migraine
headache pain itself," said study investigator Stephen D. Silberstein, MD,
FACP, FAHS, FAAN, Professor of Neurology and Director of the Jefferson Headache
Center in Philadelphia. "Treatments bypassing the GI tract may be the best
way to treat these patients." MAGNUM would like to point out that Dr. Silberstein
is one of the nation’s finest Migraine researchers.
Zecuity was approved based upon an extensive development program
with phase 3 trials that included 800 patients using more than 10,000 Zecuity
patches. In these trials, Zecuity was proven safe and effective at treating Migraine
and relieving its cardinal symptoms (headache pain, Migraine-related nausea and
sensitivity to light and sound) two hours after patch activation.
In the phase 3 pivotal study, twice as many patients treated
with Zecuity achieved freedom from headache pain at two hours compared with
placebo (18% and 9%, respectively). Additionally, 53% of patients treated with
Zecuity achieved relief from headache pain and 84% were nausea free at two
hours (29% and 63%, respectively, with placebo). The incidence of
triptan-associated adverse events known as "atypical sensations" and
"pain and other pressure sensations" was 2% each in Zecuity-treated
patients. The most common (greater than 5%) side effects of Zecuity were
application site pain, tingling, itching, warmth and discomfort.
What MAGNUM finds most exciting about the FDA’s approval of the Zecuity™ sumatriptan iontophoretic
transdermal system is its benefits to who tend to vomit up Migraine medication before
it has taken effect. This is a welcome treatment to the Migraineurs toolkit.
About Zecuity
ZECUITY™ (sumatriptan iontophoretic
transdermal system) 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.

NuPathe Inc. graphic.
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

NuPathe Inc. graphic.
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™, 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 and
our blog 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).
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.
Contact Information:
MEDIA CONTACTS:
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Tony Plohoros
(908) 940-0135
tplohoros@6degreespr.com
Sage Strategic Marketing
Jennifer Guinan
(610) 410-8111
jennifer@sagestrat.com