NuPathe Updates Migraine Patch NDA Resubmission Timing

NuPathe Inc.

, 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