Many Migraine patients, especially who find oral medications don't work well for them and / or have problems with nasal sprays and injections have been waiting for FDA approval of NuPathe, Inc.'s sumatriptan patch Zelrix.
NuPathe received a Complete Response Letter (CRL) from the FDA on August 30 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 was the first triptan developed, originally under the brand name Imitrex, so sumatriptan is hardly new. Given that, one might think FDA approval of Zelrix would be quick and simple, but it wasn't. The Zelrix patch is a new type of patch that has never been used before, 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,
"Despite the delay in obtaining FDA approval, we remain confident that we will be able to offer our Migraine patch to patients in the near future. I, like many others, suffer from Migraine with nausea and am looking forward to having a patch for treatment."
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) tract) during a Migraine attack. Zelrix's non-oral medication delivery bypasses the GI tract, 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.
