Zelrix Sumatriptan Patch & FDA Approval Process

The developer of Zelrix, a patch to deliver the migraine treatment medication Sumatriptan, has filed a New Drug Application (NDA) petition with the Food and Drug Administration (FDA). This patch is thought to offer certain advantages over currently available migraine treatment medications, which makes the lengthy, complicated process of seeking FDA approval worthwhile for NuPathe, the company developing Zelrix.

Some of the most frustrating issues related to migraine treatment medications involve the stomach. Most migraine patients deal with nausea and vomiting and many of us have noticed that these symptoms make it difficult to keep a pill down long enough for it to take effect. But a less well known fact is that there is a term for what happens in the stomach during a migraine attack: gastroparesis. Gastroparesis is the medical term for a condition in which the stomach muscles do not properly contract to propel food through the stomach. It is a component of migraine disease, but can also be experienced by people who do not have migraine attacks. Gastroparesis is responsible for the nausea and vomiting and also keeps the stomach from processing a pill for migraine treatment and getting it into the blood stream in a rapid time frame. As with nasal sprays and injections, a patch like Zelrix bypasses the stomach to avoid the problems caused by gastroparesis in delivering relief to patients trying to treat a migraine attack.

To be available to patients Zelrix must first be approved by the Food and Drug Administration (FDA), an agency of the federal government. This is where the New Drug Application (NDA) petition comes in. The purpose of the NDA is to provide the FDA with sufficient information to determine if the drug is safe and effective, if the package insert is adequate and whether the manufacturing standards will ensure the consistency and safety of the drug. The information in the NDA tells the FDA what happened during clinical trials on animals and humans, how the drug affects the body and what the medication contains. Within 60 days the FDA must decide whether to accept the petition for review or reject it for being incomplete.

An FDA team of physicians and scientists review the data submitted by the drug developer in the NDA. This team looks for weaknesses in the manufacturer's data and decides whether it agrees with the conclusions made in the application. The agency's goal is to review and act on at least 90% of drug applications within 10 months of being filed. If the team decides the drug's benefits outweigh its risks, they will approve it. Sometimes the FDA team will ask for additional information to help in making their decision. A drug may have to go through a few review cycles in order to address all problems the FDA team has highlighted. Under certain circumstances the company is unable to correct the problems keeping the drug from being approved and the NDA petition is denied.

Once the developer receives approval for the drug it can begin selling it as soon as it's possible to begin manufacturing it on a large scale and put a system of distribution in place.

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