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NuPathe Inc. (PATH) Doses Adolescent Migraineurs in Clinical Study of ZECUITY


9/23/2013 10:03:24 AM

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CONSHOHOCKEN, PA--(Marketwired - September 23, 2013) - NuPathe Inc. (NASDAQ: PATH) today announced the Company has initiated dosing of patients for NP101-015, a Phase 1 study of ZECUITY® (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 requirements.

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™, 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® (rizatriptan benzoate), Tablets.
2. US Prescribing Information Axert® (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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