CONSHOHOCKEN, PA--(Marketwire - July 16, 2012) - NuPathe Inc. (NASDAQ: PATH), a biopharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its migraine patch (NP101). NuPathe expects confirmation from the FDA regarding acceptance, resubmission classification and Prescription Drug User Fee Act (PDUFA) goal date within the next few weeks. The Company continues to expect a six-month review by FDA.
"Resubmission of the NDA for our migraine patch is an important milestone for NuPathe," said Jane Hollingsworth, chief executive officer of NuPathe. "With the additional data and enhancements made to the patch, we have submitted a strong application and have an even more attractive commercial opportunity designed to address the needs of the nearly half of migraine patients who frequently experience both headache pain and migraine-related nausea."
About the Migraine Patch (NP101 or Zelrix)
NP101 is an active, single-use, transdermal patch in development for the treatment of migraine. If approved, it will be the first transdermal patch for the treatment of migraine. The patch actively delivers sumatriptan, the most widely prescribed migraine medication. In three clinical trials involving more than 10,000 applications, NP101 offered patients fast onset and sustained relief of debilitating migraine symptoms including headache pain and migraine-related nausea (MRN). Because NP101 delivers sumatriptan transdermally, it may be an attractive treatment option for many of the approximately seven million migraineurs who might otherwise delay or avoid taking oral medication due to MRN. In addition, some migraine patients experience gastroparesis, a slowing of gastric absorption, which may affect a patient's response to oral medications. The patch utilizes SmartRelief™, NuPathe's proprietary transdermal delivery technology that allows the rapid yet tightly controlled transport of medication through the skin using a process called iontophoresis. As a result, in NP101 clinical trials there was a low incidence of triptan sensations that include chest tightness, flushing and feelings of pressure and numbness.
NuPathe Inc. is a biopharmaceutical company focused on innovative neuroscience solutions for diseases of the central nervous system including neurological and psychiatric disorders. NuPathe's lead product candidate, NP101, is an active, single-use, transdermal sumatriptan patch being developed for the treatment of migraine. In addition to NP101, 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 our pipeline products 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
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: timing of the FDA's confirmation regarding the acceptance, classification and PDUFA goal date for the resubmission; the expected review period for the resubmission; and the potential benefits of, commercial opportunity for, NP101.
Forward-looking statements are based upon our current expectations, plans 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 and adversely from those indicated by such statements including, among others: the FDA's acceptance of the resubmission for filing; the classification of the resubmission as a Class 2 resubmission resulting in a 6 month target review period; the adequacy of the activities undertaken to address the issues raised by the FDA in its complete response letter relating to our NDA for NP101; the extent to which the FDA may request or require us to provide additional information, undertake additional studies or redesign NP101; varying interpretation of study data; our ability to obtain additional capital to continue as a going concern; and the other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2011, under the caption "Risk Factors" and elsewhere in such report, which is available on our website at www.nupathe.com in the "Investor Relations -- SEC Filings" section. While we may update certain forward-looking statements and Risk factors from time to time, we 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.