SOURCE: NuPathe Inc.

NuPathe Inc.

June 26, 2013 07:30 ET

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 - Jun 26, 2013) -  NuPathe Inc. (NASDAQ: PATH) today announced the Company will present data on ZECUITY® (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®) 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 or call 1-800-FDA-1088.

Patients and healthcare providers interested in more information on Zecuity should visit

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™, 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 You can also follow us on StockTwits (, Twitter (, SlideShare ( and LinkedIn (

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 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.

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 01/03/13; and 2010, accessed at
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

    Westwicke Partners
    John Woolford
    (443) 213-0506

    Keith A. Goldan
    Vice President, Chief Financial Officer
    NuPathe Inc.
    (484) 567-0130

    Sage Strategic Marketing
    Jennifer Guinan
    (610) 410-8111