NuPathe Inc. out of Conshohocken, Pennsylvania has announced that US FDA has accepted for filing the company’s New Drug Application (NDA) for Zelrix electronic transdermal patch, a pharmaceutical designed to treat migraines. A year and a half ago we reported on positive results from a Phase III clinical trial of the single-use arm patch that quickly and consistently delivers sumatriptan on demand into the blood stream.
More about the Zelrix from NuPathe:
Zelrix is an active, single-use, transdermal sumatriptan patch in development for the treatment of migraine. Zelrix is designed to provide migraine patients fast onset and sustained relief through a tolerable, non-oral route of administration. Zelrix may provide an attractive treatment option for many migraine patients because it avoids the need for oral administration and does not depend upon gastrointestinal absorption. Many migraine patients delay or avoid treatment with oral migraine medications as a result of underlying nausea and fear of vomiting. In addition, the reduced gastric motility experienced during migraine may affect the efficacy of oral medications. Zelrix is powered by SmartRelief, NuPathe’s proprietary transdermal delivery technology. SmartRelief consists of a controlled delivery technology that uses a mild electrical current to actively transport medication through the skin using a process called iontophoresis.
Press release: NuPathe Announces FDA Acceptance of Zelrix NDA for Filing…
Product page: The Zelrix Patch…
Flashback: Zelrix, A Migraine Patch, Is Moving Forward