NuPathe Inc., 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, announced that the United States Patent and Trademark Office (USPTO) has issued a notice of allowance for US patent application 12/181,142 entitled "Transdermal Methods and Systems for the Delivery of Anti-Migraine Compounds." This application relates to methods of effectively treating a migraine using an iontophoretic patch containing a triptan. Given this action, NuPathe expects the patent to issue within the next few months.
Once issued, the patent will provide coverage for NuPathe's lead product candidate, Zelrix, through April 2027. This coverage is in addition to that provided by NuPathe's licensed US Patent No. 6,745,071, which expires in February 2023. Upon approval of NuPathe's New Drug Application (NDA) for Zelrix, NuPathe expects to list both patents in the US Food & Drug Administration's (FDA) Orange Book. NuPathe also has additional patent applications pending in the US and other territories for its migraine patch.
“This important allowance further validates the novelty of our sumatriptan transdermal patch and represents yet another significant achievement for NuPathe as we advance towards our goal of providing a tolerable, non-oral treatment for migraine patients,” said Jane Hollingsworth, chief executive officer of NuPathe. “The next milestone for NuPathe is our PDUFA date in August, which is the target date for the FDA to complete its review of our NDA for Zelrix.”
Zelrix is an active, single-use, transdermal sumatriptan patch being developed for the treatment of migraine. It 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 millions of migraine patients because it avoids the need for oral administration.
Many migraine patients delay or avoid treatment with oral medications as a result of underlying migraine-related nausea and vomiting. In addition, the absorption of oral medications may be compromised during a migraine which may adversely affect the efficacy of such 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.