NP101 – Migraine SmartRelief™

Migraine is an episodic headache disorder associated with various combinations of neurologic, gastrointestinal, and autonomic symptoms that affects approximately 36 million Americans, mostly women.  Gastrointestinal disturbances, including nausea and vomiting are quite common associated symptoms of migraine affecting over 90% of those experiencing migraine.  These GI symptoms can be incapacitating and for 30% of sufferers, migraine-associated nausea or vomiting interferes with their ability to take oral medications.  Moreover, nearly all patients suffer from gastric stasis, which, for many, adversely impacts drug absorption and pharmacokinetics, resulting in delayed, inconsistent, or incomplete relief.

While non-oral formulations are available, only sumatriptan injection does not depend on GI absorption.  Both nasal and melt formulations are absorbed primarily through the GI tract.  Moreover, few patients elect to use current non-oral formulations due to discomfort, inconvenience, and adverse effects.

NP101 Migraine SmartRelief™ is a potentially empowering alternative for migraine sufferers – convenient, consistent, and controlled delivery of their migraine medication regardless of nausea, vomiting, or other gastric symptoms associated with migraine.   

NP101 Migraine SmartRelief™ is a novel transdermal formulation of sumatriptan using NuPathe’s proprietary SmartRelief™ technology.  NuPathe has competed several Phase I studies, demonstrating that therapeutic blood levels can be obtained rapidly, consistently, and tolerably.  Initial Phase I studies have been completed with positive results and Phase III trials are scheduled to initiate in the first half of 2008.

Facts about migraine

An estimated 36 million Americans suffer from migraine Migraine costs the US economy over $13 billion in lost work and productivity each year Annual sales of triptans, the leading class of agents for acute migraine, exceed $2 billion in the US Over 50% of migraine sufferers experience nausea in a majority of their attacks    For more information about migraine: American Headache Society American Headache Foundation