CONSHOHOCKEN, PA--(Marketwire - July 02, 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 believes it has successfully completed all CMC and development work to address the U.S. Food and Drug Administration's (FDA) questions related to the New Drug Application (NDA) for its migraine patch (NP101). The only remaining activity related to the NDA resubmission is the completion of writing and collation of the document. The Company expects to resubmit its NDA in July and continues to anticipate a six-month review by the FDA.
Primary activities that have been successfully completed include:
- A Phase I study to confirm the performance of a device enhancement that prevents the patch from activating in the event that it is applied incorrectly
- A packaging improvement related to product containment and uniformity of dosage
- A usability study to demonstrate that patients can easily use the patch during a migraine
- Development and validation of a new in vitro testing method
- A Phase I bioequivalence study
- Additional data to support the justification for a waiver of the dermal carcinogenicity study
"Our team did a tremendous job designing and implementing the device enhancement and packaging modification," said Jane Hollingsworth, chief executive officer of NuPathe. "These improvements strengthen our NDA, better the patient experience and bolster the commercial opportunity for our migraine patch."
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 medication due to MRN. In addition, clinical trials suggest that many migraineurs fail to respond consistently to orally administered medications. This may result from a variety of causes including gastroparesis, a slowing of gastric absorption experienced by some migraine sufferers. 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 and based on clinical trial experience, the patch may offer 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: the timing of NuPathe's resubmission of its NDA for NP101; the FDA's review of such resubmission; and the potential benefits of, commercial opportunity for, NP101.
Forward-looking statements are based upon management's current expectations, plans and beliefs and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially from those indicated herein including, among others: NuPathe's interpretation of the FDA's complete response letter (CRL) relating to its NDA for NP101 and its interactions with the FDA regarding the CRL; the adequacy of the additional trials, tests, device enhancement, packaging modification and other activities completed by NuPathe to support the resubmission of its NDA for NP101; the extent to which the FDA may request or require NuPathe to provide additional information, undertake additional trials or studies or redesign NP101; serious adverse events or other safety risks that could require NuPathe to abandon or delay development of, or preclude or limit approval of its product candidates; varying interpretation of study data; the amount of time required to complete the writing and collation of the NDA resubmission document; NuPathe's ability to obtain additional capital to continue as a going concern; and the risks, uncertainties and other factors discussed in NuPathe's 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 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.