SOURCE: NuPathe Inc.

NuPathe Inc.

October 11, 2010 07:00 ET

NuPathe Announces Successful Completion of Three Key Trials for Zelrix™

New Drug Application for Zelrix on Track for Submission in Fourth Quarter of 2010

CONSHOHOCKEN, PA--(Marketwire - October 11, 2010) -  NuPathe Inc. (NASDAQ: PATH), a specialty pharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, today announced the completion of two recently completed Zelrix pharmacokinetic trials and a tolerability trial. Zelrix is a single-use, transdermal sumatriptan patch in development for the treatment of migraine.

"We are very excited about the results of these three trials," said Jane Hollingsworth, chief executive officer of NuPathe. "Given the completion of these studies and the continued progress of our ongoing long-term safety studies, we remain on track to submit our New Drug Application (NDA) for Zelrix to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2010." 

The first trial compared the pharmacokinetics of Zelrix in healthy elderly volunteers to healthy young adult volunteers and the pharmacokinetics of Zelrix applied to the upper arm and applied to the thigh. The results demonstrated no clinically significant difference in the pharmacokinetic profile of Zelrix based upon age or application site. Zelrix was well tolerated in the trial with no serious adverse events reported. 

The second trial was a confirmatory bioavailability study and the third trial was a safety study that evaluated cumulative skin irritation of Zelrix when applied daily to the same application site. Both trials were successfully completed. The results of all three studies will be used to support our NDA filing for Zelrix. 

"Zelrix was designed specifically to overcome the limitations of current migraine therapies by providing rapid and controlled delivery of sumatriptan while bypassing the need for oral administration and reliance on gastrointestinal absorption," commented Mark Pierce, MD PhD, chief scientific officer of NuPathe. "Successful completion of these three studies brings us one step closer to making this important therapy available to the many migraine patients underserved by current treatments. We plan to present detailed results from these studies at an appropriate medical meeting in the future."

About Zelrix
Zelrix is an active, single-use, transdermal sumatriptan patch in development for the treatment of migraine. Zelrix is designed to provide migraine patients fast onset and sustained relief through a tolerable, non-oral route of administration. We believe Zelrix may provide a better alternative for many migraine patients by circumventing treatment-altering nausea and vomiting, by increasing consistency of response, and by minimizing the incidence of triptan adverse events. Zelrix is powered by SmartRelief™, our proprietary transdermal delivery technology. SmartRelief consists of a controlled delivery technology that uses a mild electrical current to actively transport medication through the skin using a process called iontophoresis.

About Migraine
Migraine is a debilitating neurological disease that affects approximately 28 million people in the U.S. Symptoms of migraine include moderate to severe headache pain, nausea and vomiting, photophobia, and phonophobia. Most migraines last between four and 24 hours, but some last as long as three days. According to published research, 63% of migraine sufferers experience between one and four migraines per month.

In a majority of their migraines, most patients suffer from one or more significant gastrointestinal problems, which include nausea, vomiting and a compromised ability to digest, known as decreased gastric motility. Nausea and vomiting often impede the use of oral medications, while reduced gastric motility can result in inconsistent efficacy. According to a survey with over 500 respondents conducted by the National Headache Foundation in 2008, 90% of migraine patients have experienced nausea with a migraine and 59% of migraine patients have experienced vomiting with a migraine. In this survey, 48% of respondents who ever experienced nausea or vomiting with a migraine reported that the nausea or vomiting had a moderate to major impact on when or how they take migraine medications.

About NuPathe
NuPathe Inc. (www.nupathe.com) is a specialty pharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, including neurological and psychiatric disorders. NuPathe's most advanced product candidate, Zelrix, is a single-use, transdermal sumatriptan patch being developed for the treatment of migraine. In addition to Zelrix, NuPathe has two proprietary product candidates in preclinical development: NP201 for the continuous symptomatic treatment of Parkinson's disease, and NP202 for the long-term treatment of schizophrenia and bipolar disorder. 

Forward-Looking Statements

All statements contained in this press release that are not statements of historical facts are hereby identified as "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to, among other things, (i) our interpretation of clinical data from the referenced trials and our plan to present such data at a medical meeting in the future, (ii) the timing of the submission of our NDA for Zelrix, and (iii) the potential benefits of, and market for, Zelrix and our other product candidates. The words "may," "will," "intend," "plan," "anticipate," "believe," "potential," "continue," "ongoing" "remain," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and uncertainties relating to: (i) our ability to timely complete clinical and preclinical trials, (ii) varying interpretation of clinical data from the referenced trials, and (iii) serious adverse events or other safety risks that could require us to abandon or delay development, and preclude or limit approval of, Zelrix. For further information with respect to these and other factors that could cause actual results to differ materially from those indicated in this press release, reference is made to the "Risk Factors" section of our From 10-Q for the quarter ended June 30, 2010, which is on file with the Securities and Exchange Commission. In addition, the forward-looking statements contained in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so.

Contact Information

  • MEDIA CONTACTS
    Ron Schmid
    NuPathe Inc.
    (610) 659-3985

    INVESTOR CONTACTS
    John Woolford
    (443) 213-0506
    Email Contact

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