Updates on Migraine Abortives Levadex and Zecuity

Nancy Harris Bonk Health Guide
  • For many people with Migraine disease, abortive treatment options are limited. This may be due to stomach upset and vomiting, gastric stasis (belated stomach emptying) and/or that the medications don't work fast enough. Teri and I have reported on two potential novel treatments, Zecuity (formerly called Zelrix) and Levadex. Both medications have been in the news recently, which means it's time for an update.

     

    Nupathe, the developers of Zecuity, is a biopharmaceutical business that creates drugs for central nervous system diseases. Zecuity, which would be their lead product if approved by the FDA, is a transdermal patch using NuPathe's privately owned SmartRelief™ system. This transdermal system, called iontophoresis, administers mild electrical currents delivering the drug sumatriptan (brand name Imitrex) through the skin. The company was required to apply for a New Drug Application (NDA) to the Food and Drug Administration (FDA) in July  2012 because they received a complete response letter (CRL). The FDA sends CRLs when new or generic drugs cannot be approved in their current state.

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    The CRL NuPathe received indicated concerns regarding chemistry, manufacturing and safety, not efficacy; Zecuity did meet sufficient efficacy standards in their Migraine population. NuPathe also expects to receive a Prescription Drug User Fee Act (PDUFA) in January 2013, which allows the FDA to collect fees from companies who produce certain human drug and biological products. This helps expedite the drug approval process.

     

    DHE (dihydroergotamine) can be used by IV infusion at clinics and hospitals, injection or nasal spray to abort a Migraine attack. Levadex is MAP Pharmaceuticals' unique orally-inhaled DHE using TEMPO®, an inhaler similar that resembles an asthma inhaler. This inhaler releases DHE into the airway, aborting an attack. As with NuPathe, MAP Pharmaceuticals received a CRL from the FDA in March 2012 expressing concerns about chemistry, manufacturing and controls of Levadex. MAP addressed the FDA's concerns regarding third party "implementation and documentation of process controls" by working closely with the third party facility that handles the manufacturing process to resolve these issues. MAP originally filed a NDA in October 2012, which included the 24 month data on the stability of Levadex that the FDA agreed needed to be included in the NDA.

     

    Both of these medications are sorely needed for those with Migraine disease because of their novel delivery systems. They may both be helpful with something that has been referred to as "triptan sensation." "Triptan sensation" is a set of side effects similar to the symptoms of angina that, unfortunately, some people experience when they use triptans. These side effects can include anxiety, chest pain and/or discomfort, dizziness, fatigue, nausea, neck and/or jaw pain and sweating. We've been waiting a long time for these treatments, and their approvals can’t come fast enough.

     

    For more information:

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    Zelrix Submitted to FDA for Approval for Migraine Treatment

    Update: Zelrix Sumatriptan Patch for Migraine

    FDA Approval of Zelrix Migraine Patch Delayed


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    Resources:


    Loder, E.; Biondi,D. "Can This Patient Take A Triptan?: Review Of The Cardiovascular Safety Of The Triptans And Recommendations For Patient Selection And Evaluation." The Internet Journal of Neurology. 2004; Volume 3 Number 1. DOI: 10.5580/1849.

     

    Matusow, Scott. "NuPathe Pharma: Potentially A Triple In Stock Price On FDA Approval." Seeking Alpha. October 17, 2012.

     

    Fact Sheet. "Zecuity." NuPathe. October 21, 2012.  http://www.nupathe.com/pipeline/zecuity-migraine.

     

    FDA Drugs. "Questions and Answers Regarding Complete Response Letter." U.S. Food and Drug Administration. Last updated April 30, 2009.

     

    FDA Industry. "Prescription Drug User Fee Act (PDUFA)." U.S. Food and Drug Administration. Last updated  August 16, 2012.

     

    Press Release. "MAP Pharmaceuticals Provides Update Following Meeting with FDA for Levadex (dihydroergotamine) New Drug Application." Seeking Alpha. Mountain view California. June 25, 2012. http://tinyurl.com/8zwmgc9.

     

    Product Profolio. "Levadex." MAP Pharmaceuticals. 2011. http://www.mappharma.com/product-portfolio/levadex.

     

     

    Thanks for reading,

     

    NancySig

     


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    © HealthCentral Network, 2012 
    Last updated Ocotber 23, 2012.

     

Published On: October 23, 2012