Zelrix Resubmitted to FDA
Today NuPathe,Inc, announced that it has resubmitted it’s sumatriptan patch Zelrix to the US Food and Drug Administration (FDA) for approval. On August 30th, 2011 the NuPathe received a Complete Response Letter (CRL) from the FDA asking for more information regarding the patch. Apparently, NuPathe feels it has compiled all the needed information needed to address to questions in the CRL and it has resubmitted Zelrix to the FDA for approval.
“With the additional data and enhancements made to the patch, we have submitted a strong application and have an even more attractive commercial opportunity designed to address the needs of the nearly half of migraine patients who frequently experience both headache pain and migraine-related nausea.” said Jane Hollingsworth, chief executive officer of NuPathe.
Although the active ingredient in Zelrix is sumatriptan (the same active ingredient as Imitrex), Zelrix delivers the medicine through the skin (transdermally) via a patch, avoiding the stomach and gastro-intestinal tract. Since nausea and vomiting are common symptoms for many migraineurs, this type of delivery may offer benefit versus taking a pill.
The company states that in three clinical trials involving more than 10,000 applications, Zelrix offered patients fast onset and sustained relief of debilitating migraine symptoms including headache pain and migraine-related nausea (MRN). Additionally, since Zelrix uses a proprietary transdermal delivery technology that allows the rapid yet tightly controlled transport of medication through the skin. And as a result, in Zelrix clinical trials there was a low incidence of so-called “triptan sensations” associated with sumatriptan and other drugs in the same class that include chest tightness, flushing and feelings of pressure and numbness.
The company expects that within a few weeks they will hear back from the FDA on how long they will need to provide a final decision. The company expects this resubmission to receive an answer within six months, but ultimately that is up tp the FDA
So we sit and we wait, but all in all, this is a positive step for those who suffer from nausea along with their migraines who may be interested in trying this new product if and when it is approved.