NuPathe Inc, a specialty pharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, has submitted a New Drug Application (NDA) for Zelrix to the US Food and Drug Administration (FDA). Zelrix is the first ever submission to the FDA of a transdermal patch for the treatment of migraine.
"The NDA submission for Zelrix represents a tremendous milestone for the company and the millions of underserved migraine patients," said Jane Hollingsworth, chief executive officer of NuPathe. "The dedication and persistence of our employees allowed us to develop this truly novel solution and achieve our goal of submitting the NDA prior to year end."
Migraine is a neurological disorder that affects approximately 28 million adults in the US. In addition to a debilitating headache, most migraine patients suffer from one or more significant gastrointestinal problems, including nausea, vomiting and a compromised ability to digest, known as decreased gastric motility. The nausea and vomiting associated with a migraine makes it difficult for many patients to take oral medications, while reduced gastric motility can affect the efficacy of oral medications.
The most prescribed treatments for acute migraine in the US are triptans, accounting for 94 per cent of the 13 million prescriptions filled for acute migraine therapies in 2009. Yet, triptan-related adverse events including chest tightness, chest heaviness, paresthesias, and panic can lead some patients to avoid or delay treatment with triptans. Zelrix delivers sumatriptan, the leading triptan medication, in a controlled manner to minimize these triptan adverse events while still achieving efficacy for patients.
"We designed Zelrix specifically to overcome the limitations of current treatments by avoiding oral administration and controlling the delivery of medication with our SmartRelief transdermal technology," said Mark Pierce, chief scientific officer of NuPathe. "Results from the clinical development program demonstrate efficacy and a favorable tolerability profile for Zelrix in both our single migraine pivotal trial and our long-term open label trial, during which patients used Zelrix over a 12 month period."
The NDA submission is based on a comprehensive development programme, including data from a pivotal phase-III trial (NP101-007) conducted in 530 migraine patients, where the efficacy and tolerability of Zelrix were compared with a matching placebo patch. In that trial, Zelrix met the pre-defined efficacy endpoints of a statistically significant improvement compared to placebo at two hours after patch application for pain free (p=0.0092), pain relief (p < 0.0001), nausea free (p < 0.0001), photophobia free (p=0.0028), phonophobia free (p=0.0002), and migraine free (p=0.0135). Additionally, in our 12-month long-term open label trial (NP101-008) in which 183 patients enrolled, Zelrix demonstrated efficacy for these same endpoints consistently throughout the duration of the trial.
Zelrix was well-tolerated in both the pivotal phase-III trial and the 12-month long-term open label trial. The most common adverse events were related to the patch application site and included application site pain, itching, tingling, and skin reaction. The majority of adverse events were mild and transient. The incidence of triptan-specific adverse events reported for Zelrix was very low. We believe this low incidence, taken together with the efficacy demonstrated in our clinical trial program, validates the benefit of controlled transdermal delivery. Importantly, the safety and tolerability profile of Zelrix remained consistent over the course of the 12 months of the long-term open label trial.
To date, in the phase-III clinical development program, Zelrix has been evaluated in approximately 800 patients treated for up to one year.
Zelrix is an active, single-use, transdermal sumatriptan patch in development for the treatment of migraine.
NuPathe is a specialty pharmaceutical company focused on the development and commercialization of branded therapeutics for diseases of the central nervous system, including neurological and psychiatric disorders.