Zelrix Migraine Patch – FDA Approval Delayed
Posted by Teri-Robert—September 6th, 2011

Migraine patients who find oral medications don’t work well for them have been anxiously awaiting word of FDA approval of NuPathe, Inc.’s sumatriptan patch Zelrix.

On August 30, NuPathe received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for Zelrix. A CRL is issued by the FDA’s Center for Drug Evaluation and Research when the review of an NDA is completed and questions remain that preclude the FDA from approving the NDA at the time.

Sumatriptan is the triptan that was originally the brand name Imitrex, so sumatriptan is hardly new. One might think that made approval of Zelrix simple and somewhat a “no-brainer.” Not so. The Zelrix patch is a novel delivery system, and that made the approval of Zelrix more complex. In the CRL, the FDA acknowledged that NuPathe had established the efficacy of Zelrix. The CRL primarily contained chemistry, manufacturing and safety questions, which the Company believes it has, or shortly will have, sufficient data to address. The Company may conduct additional Phase I and/or non-clinical studies to address other questions. NuPathe has requested an End-of-Review meeting with the FDA to discuss the CRL and NuPathe’s approach to resolving the outstanding issues.

In an interview, Jane Hollingsworth, CEO of NuPathe, told me,

“We are disappointed in the delay in obtaining FDA approval for our patch but remain no less committed to working hard to bring this new migraine medicine to market as soon as possible. As a migraine sufferer, I know firsthand the problem that nausea with migraine causes. That is why we have been working the last six years to develop a migraine patch for patients.”

About Zelrix

Zelrix single-use, transdermal sumatriptan patch being developed for the acute treatment of Migraine. It’s designed to provide Migraineurs fast onset and sustained relief of the cardinal migraine symptoms including headache pain, migraine-related nausea, and sensitivity to light and sound. The migraine patch offers a non-oral route of administration of sumatriptan, the most widely prescribed migraine medication, with low incidence of triptan-related adverse events that can include chest tightness, flushing, feelings of pressure, and numbness. Zelrix may provide an attractive treatment option for millions of Migraineurs who delay or avoid treatment with oral medications because of migraine-related nausea (MRN). In addition, studies have shown that many Migraineurs experience gastric stasis (slowing of the gastrointestinal (GI) track) during a Migraine attack. Zelrix’s non-oral medication delivery bypasses the GI track, which may be an appealing treatment for these patients. Zelrix is powered by SmartRelief, NuPathe’s proprietary transdermal delivery technology. SmartRelief consists of a controlled delivery technology that rapidly transports medication through the skin using a process called iontophoresis.

Iontophoresis involves using a mild electrical current delivered to the skin that allows medications that otherwise can’t be delivered through the skin to travel into the skin, where the bloodstream can absorb the medication and deliver it throughout the body.

What’s next?

At this point, we’re waiting to see what happens with the CRL and the End-of-Review meeting. It’s difficult to estimate how long this process will take and how long it will take for a final determination on the approval of Zelrix.

As a Migraineur, a patient advocate, and a concerned citizen, I sent an email to Dr. Russell Katz, the director of the Division of Neurology Products for the FDA’s Center for Drug Evaluation and Research (CDER). Here’s what I said to him:

“I am writing you both as a patient with Migraines and as a patient educator and advocate in the area of Migraine and other headache disorders regarding the NDA and the CRL for NuPathe, Inc’s new acute Migraine treatment NP101/Zelrix.

With so many NDA’s to work with, it’s undoubtedly very difficult for FDA reviewers to fully understand the impact of every disease and the potential patient benefit of every drug for which FDA received an NDA. Personally and professionally, I come into contact with thousands of Migraineurs and have learned a great deal about how the symptoms impact us and the narrow range of medications developed to treat Migraine. For many of us, symptoms other than headache are more debilitating than the headache. Nausea is one of the symptoms that impacts us most severely. Even if we’re able to stay at work and be productive despite the pain, nausea often makes it difficult, if not impossible to work during a Migraine attack. Nausea and vomiting also make it difficult to use orally administered medications. Additionally, for many of us, the gastric stasis that can accompany a Migraine either slows the relief we get from oral medications or renders them useless.

Medications delivered via nasal sprays are also problematic for many of us because they can make nausea worse and induce vomiting. The congestion and rhinorrhea that can accompany a Migraine compound the issues with medications delivered via nasal spray. Sumatriptan injections are costly, even the generics, and too many Migraineurs do not do well with self-injecting.

The iontophoretic delivery system of NP101/Zelrix is unique in its transdermal delivery. Since it bypasses the gastrointestinal tract, it would be less likely to increase nausea, would not be affected by vomiting, and gastric stasis would not interfere with its delivery.

It’s my sincere hope that FDA and NuPathe are able to work as quickly as possible through the issues in the CRL that was issued by FDA last week. The struggles for effective Migraine treatment weigh heavily on the more than 37 million Americans who have Migraines, and we need help. At this point in time, there are absolutely no medications on the market that were originally developed for the prevention of Migraine. FDA has approved four medications for the treatment of Migraine and one for the treatment of chronic Migraine, but all of these are “hand-me-down” drugs originally developed for other conditions. This adds to the burden of the disease so significantly that too many Americans find themselves so debilitated by Migraines that they are unable to work or care for their families. The approval of this new acute treatment would at least give us another option for acute treatment. The World Health Organization has stated that a severe Migraine attack can be as debilitating as quadriplegia. We need all the assistance we can get.”

If you’d like to send him an email, his email address is russell.katz@fda.hhs.gov.

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