NuPathe's Zecuity Approved by the FDA for the Acute Treatment of
First FDA-Approved Migraine Patch
Conference Call Scheduled January 18 at 8:30 a.m. EST
CONSHOHOCKEN, PA -- (Marketwire) -- 01/17/13 -- NuPathe Inc.
(NASDAQ: PATH) today announced that the U.S. Food and Drug
Administration (FDA) has approved Zecuity(TM) (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 medication, through the skin. Zecuity
provides relief of both migraine headache pain and migraine-related
"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 headache 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."
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.
ZECUITY(TM) (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.
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
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
Patients and healthcare providers interested in more information on
Zecuity should visit www.zecuity.com.
Company to Host Investor Conference Call
NuPathe will host a
conference call tomorrow, January 18, 2013, at 8:30 a.m. EST to
discuss the FDA approval of Zecuity. A question and answer session
will follow NuPathe's remarks. To participate on the live call,
please dial 888-329-8862 (domestic) or +1-719-325-2420
(international), and provide the participant passcode 9170164 five to
ten minutes before the start of the call. A live audio webcast of the
call will be available via the Investor Relations page of the NuPathe
website, www.nupathe.com. Please log on through NuPathe's website
approximately 10 minutes prior to the scheduled start time.
A replay of the webcast will also be archived on the Company's
website for 90 days following the call. A replay of the call will be
available for 90 days within a few hours after the call ends.
Investors may listen to the replay of the call by dialing
888-203-1112 (domestic) or +1-719-457-0820 (international), with the
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. 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 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).
Cautionary Note Regarding Forward-Looking Statements
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; the timing of the expected launch and availability of
Zecuity; and other statements relating to NuPathe's plans,
objectives, expectations and beliefs regarding its future operations,
performance, financial condition and other future events.
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,
2010 and Quarterly Report on Form on Form 10-Q for the quarter ended
September 30, 2012 under the caption "Risk Factors" and elsewhere in
such reports, which are 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
1. ICHD-II. Cephalagia 2004; 24 (Suppl 1).
2. Lipton, R. et al.
Classification of primary headaches. Neurology. 2004:63:427-435.
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/.
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.
Sage Strategic Marketing
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