FDA Accepts NuPathe's Migraine Patch NDA Resubmission for Filing
PDUFA Date of January 17, 2013
CONSHOHOCKEN, PA, Jul 31, 2012 -- NuPathe Inc. PATH +1.03% , a biopharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, today announced that the company's New Drug Application (NDA) resubmission for its migraine patch (NP101) has been accepted for filing by the U.S. Food and Drug Administration (FDA). NuPathe has received a Prescription Drug User Fee Act (PDUFA) date, the target date for the FDA to complete its review of the NDA, of January 17, 2013.
"As important as FDA acceptance of our NDA resubmission is for NuPathe, we believe it's even more significant for the millions of migraine patients who suffer from headache pain and debilitating migraine-related nausea," said Armando Anido, chief executive officer of NuPathe. "We look forward to working closely with the FDA to complete its review and to bringing our innovative new treatment option to migraine patients in 2013."
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 frequent MRN sufferers and those patients who experience gastroparesis, a slowing of gastric absorption. The patch utilizes SmartRelief(TM), 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.
About Migraine and Migraine-Related Nausea Migraine is a neurological disorder that affects approximately 30 million adults in the U.S. In addition to a headache pain, most migraine patients suffer from one or more significant gastrointestinal problems, including nausea, vomiting, and gastroparesis. Approximately eight million diagnosed migraine sufferers experience MRN in greater than fifty percent of their migraines. These frequent-MRN sufferers are less likely to achieve headache relief with oral triptans and are less satisfied with their current migraine medications. They experience more medication-related interference in several aspects of life, including their ability to work and spend time with family. In addition, these patients generate increased direct medical costs as a result of their five-fold increase in emergency room and urgent care visits and eight-fold increase in overnight hospital stay costs. Some migraine patients also experience gastroparesis, which may affect a patient's response to oral medications.
About NuPathe 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(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 our pipeline products in the U.S. and territories throughout the world.
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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 completion of the FDA's review of our NDA for NP101; the timing of when NP101 may be available to patients; and the potential benefits of, and 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 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.